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A Clinical Trial of TQB2618 Injection Combined With Penpulimab Injection and Chemotherapy Versus Penpulimab Injection Combined With Chemotherapy in First-line Treatment of Relapsed/Metastatic Head and Neck Squamous Cell Carcinoma

Primary Purpose

Recurrent Squamous Cell Carcinoma of the Head and Neck, Metastatic Squamous Cell Carcinoma

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
TQB2618 injection, Penpulimab injection, Paclitaxel, Cisplatin or Carboplatin
Penpulimab injection, Paclitaxel, Cisplatin or Carboplatin
Sponsored by
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Squamous Cell Carcinoma of the Head and Neck

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The subjects voluntarily joined the study, signed the informed consent form, and had good compliance. Between the ages of 18-75 years (calculated based on the date of signing ICF); male or female; Eastern cooperative oncology group (ECOG) score 0-1; estimated survival time ≥ 3 months. No indications of local radical therapy for recurrence/metastasis head and neck squamous cell carcinoma.And histologically- or cytologically-confirmed head and neck squamous cell carcinoma ,Primary tumor locations of oropharynx, oral cavity, hypopharynx, or larynx. No systemic therapy for recurrent/metastatic lesions, but excluding systemic therapy for locally advanced disease as a part of multimodal therapy (including induction therapy, systemic therapy in the same period of radiotherapy, and adjuvant therapy), and the completion time of treatment was more than 6 months from enrollment (according to the date of informed consent); At least one measurable lesion (based on RECIST1.1). The main organs function are normally, the following criteria are met: hemoglobin (Hb) ≥90g/L (no blood transfusion and blood products within 14 days) ;absolute neutrophil count (ANC) ≥1.5×109/L; platelets (PLT) ≥90×109/L. Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN. If accompanied by liver metastases, ALT and AST ≤ 5×ULN; Serum creatinine (CR) ≤ 1.5×ULN or creatinine clearance (CCR) ≥ 60 ml/min. Prothrombin time (PT), activated partial thromboplastin time (APTT), international normalized ratio (INR) ≤ 1.5×ULN (no anticoagulant therapy); Thyroid-stimulating hormone (TSH) ≤ ULN; If abnormalities should be examined, T3 and T4 levels should be examined, and T3 and T4 levels are normal. Cardiac ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ 50%. Female participants of childbearing age should agree to use contraception (e.g., IUDs, pills, or condoms) during the study period and for 6 months after the end of the study; Have a negative serum pregnancy test within 7 days prior to study enrollment and must be a non-lactating subject; Male participants should agree that contraception must be used during the study period and for 6 months after the end of the study period. Exclusion Criteria: Comorbidity and medical history: Have had or currently have other malignant tumors within 3 years. The following two conditions can be enrolled: other malignancies treated with a single surgery to achieve 5-year disease-free survival (DFS); cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumors), Tis (carcinoma in situ) and T1 (tumor-invasive basement membrane)]; adverse effects due to any prior treatment have not been restored to CTCAE 5.0 ≤ level 1 (except for toxicity where the investigator determines that there is no safety risk); Major surgical treatment, incision biopsy, or significant traumatic injury were received within 28 days prior to study treatment Long-term unhealed wounds or fractures Arteriovenous thrombotic events within 6 months, such as cerebrovascular accidents; Those who have a history of psychotropic substance abuse and cannot quit or have a mental disorder; Subjects with any severe and/or uncontrolled medical conditions, including: Unsatisfactory blood pressure control (systolic blood pressure ≥ 150mmHg or diastolic blood pressure ≥100 mmHg); Have grade ≥2 myocardial ischemia or myocardial infarction, arrhythmias (including QTc ≥ 450 ms (male) in men and QTc ≥ 470 ms (female)) and grade ≥ congestive heart failure grade 2 (New York Heart Association (NYHA) grade); Active or uncontrolled severe infection (≥ CTC AE grade 2 infection) or unexplained fever > 38.5°C; Liver cirrhosis, active hepatitis Note: Active hepatitis (hepatitis B reference: HBsAg positive and HBV (hepatitis B virus) DNA detection value of more than 1000 copies /mL; Hepatitis C reference: HCV (hepatitis C virus) antibody positive, and HCV virus titer test value above the upper limit of normal); Known to have syphilis; Renal failure requires hemodialysis or peritoneal dialysis A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; Poor diabetes control [fasting blood glucose (FBG) > 10mmol/L] Urine routine indicated urine protein ≥++, and confirmed 24 hours urine protein quantity > 1.0 g People who have epilepsy and need treatment Tumor related symptoms and treatment Study history of surgery, chemotherapy, radiotherapy, or other anticancer therapy within 4 weeks prior to the start of treatment (washout period from the end of the last treatment); progress during or within 6 months of completion of systemic therapy (including induction therapy, concurrent radiotherapy, adjuvant therapy) for locally advanced disease; Secondary radiotherapy was performed for local recurrent lesions; Received Chinese patent drugs with anti-tumor indications specified in the Chinese National Medical Product Administration approved drug instructions within 1 week before the study treatment; Have received relevant immunotherapy drugs in the past; where imaging (CT or MRI) shows that the tumor has invaded important blood vessels, or the investigator determines that the tumor is highly likely to invade important blood vessels and cause fatal massive bleeding during the follow-up study period; Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (investigator's judgment) Subjects with known central nervous system metastatic and/or cancerous meningitis; Research and treatment related: Study history of live attenuated vaccine vaccination within 28 days before the start of treatment or planned live attenuated vaccine vaccination during the study period; Patients with a definite tendency to bleed or clinically significant bleeding symptoms, including but not limited to gastrointestinal bleeding, nasal bleeding, and hemorrhagic disease or coagulopathy within 28 days prior to initial medication; People who have experienced severe hypersensitivity after the use of monoclonal antibodies, or are allergic to known components of the drug under study; Study of active autoimmune diseases requiring systemic treatment that occurred within 2 years prior to initiation of treatment; Have been diagnosed with immunodeficiency or are receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy (dose > 10mg/ day prednisone or other efficacy hormone) and continue to use within 2 weeks before the study therapy begins; Participated in clinical trials of other antitumor drugs within 4 weeks before the first medication; Subjects who, in the judgment of the investigator, have concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study, or subjects who are not suitable for inclusion for other reasons.

Sites / Locations

  • Gansu Prouincial Cancer HospitalRecruiting
  • Jiangmen Central HospitalRecruiting
  • Guangxi Medical University Cancer HospitalRecruiting
  • Harbin Medical University Cancer HospitalRecruiting
  • AnYang Tumor HospitalRecruiting
  • The First Affiliated Hospital of Henan University of Science and TechnologyRecruiting
  • The First Affiliated Hospital of Zhengzhou UniversityRecruiting
  • Zhumadian Centre HospitalRecruiting
  • Hunan Cancer HospitalRecruiting
  • Jiangxi Cancer HospitalRecruiting
  • Liaoning Cancer hospitalRecruiting
  • The Second Hospital Of Dalian Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TQB2618 injection +Penpulimab injection+Chemotherapy (Paclitaxel+Cisplatin or Carboplatin)

Penpulimab injection + Chemotherapy (Paclitaxel+Cisplatin or Carboplatin)

Arm Description

TQB2618 injection combined with Penpulimab injection, Paclitaxel, Cisplatin or Carboplatin, 21 days as a treatment cycle. After 4~6 cycles, TQB2618 injection combined with Penpulimab injection, 21 days as a treatment cycle.

Penpulimab injection combined with Paclitaxel, Cisplatin or Carboplatin, 21 days as a treatment cycle. After 4~6 cycles, Penpulimab injection, 21 days as a treatment cycle.

Outcomes

Primary Outcome Measures

Progression free survival (PFS)
The time period from the first administration of the drug to disease progression or death event (whichever occurs first).
Objective response rate (ORR)
According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and iRECIST, the proportion of subjects whose tumors are evaluated as complete response(CR) and partial response(PR) by subcenter imaging evaluation. It is recorded from the first administration of the drug to disease progression or initiation of a new anticancer treatment.

Secondary Outcome Measures

PFS rate at 9 months
Proportion of survived participants without progression at 9th months.
Overall survival (OS)
Time from the randomization to death from all causes.
Disease Control Rate (DCR)
The percentage of participants with complete response (CR), partial response (PR), or stable disease (SD) for 6 weeks or more as determined by investigators according to RECIST 1.1.
Clinical benefit rate (CBR)
The percentage of participants with complete response (CR), partial response (PR), or stable disease (SD) for 6 months or more as determined by investigators according to RECIST 1.1.
Duration of Remission (DOR)
The period from firstly-recorded objective tumor response (CR or PR) to firstly-recorded objective tumor progression or death due to any cause (whichever occurs first).
Incidence of adverse events (AEs)
All adverse medical events that occur after the subject receives the investigational drug may be manifested as symptoms, signs, disease, or laboratory abnormalities, but are not necessarily causally related to the investigational drug, evaluated according to the National Cancer Institute standard for common toxic criteria [NCI-CTC v5.0].
Severity of adverse events (AEs)
All adverse medical events that occur after the subject receives the investigational drug may be manifested as symptoms, signs, disease, or laboratory abnormalities, but are not necessarily causally related to the investigational drug, evaluated according to the National Cancer Institute standard for common toxic reactions [NCI-CTC v5.0].
Serious adverse events (SAEs)
It refers to adverse medical events such as death, life-threatening, permanent or serious disability or loss of function, hospitalization or prolonged hospitalization, and congenital abnormalities or birth defects after the subject receives the experimental drug.

Full Information

First Posted
March 8, 2023
Last Updated
July 26, 2023
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05783921
Brief Title
A Clinical Trial of TQB2618 Injection Combined With Penpulimab Injection and Chemotherapy Versus Penpulimab Injection Combined With Chemotherapy in First-line Treatment of Relapsed/Metastatic Head and Neck Squamous Cell Carcinoma
Official Title
A Randomized, Open, Multicenter Phase 1/Phase 2 Clinical Trial of TQB2618 Injection Combined With Penpulimab Injection and Chemotherapy Versus Penpulimab Injection Combined With Chemotherapy in First-line Treatment of Relapsed/Metastatic Head and Neck Squamous Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2023 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
To evaluate the efficacy and safety of TQB2618 injection combined with Penpulimab and chemotherapy in the first-line treatment of relapsed/metastatic head and neck squamous cell carcinoma compared to Penpulimab combined chemotherapy. Progression-free survival (PFS) and objective response rate (ORR) were the primary efficacy endpoints.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Squamous Cell Carcinoma of the Head and Neck, Metastatic Squamous Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TQB2618 injection +Penpulimab injection+Chemotherapy (Paclitaxel+Cisplatin or Carboplatin)
Arm Type
Experimental
Arm Description
TQB2618 injection combined with Penpulimab injection, Paclitaxel, Cisplatin or Carboplatin, 21 days as a treatment cycle. After 4~6 cycles, TQB2618 injection combined with Penpulimab injection, 21 days as a treatment cycle.
Arm Title
Penpulimab injection + Chemotherapy (Paclitaxel+Cisplatin or Carboplatin)
Arm Type
Active Comparator
Arm Description
Penpulimab injection combined with Paclitaxel, Cisplatin or Carboplatin, 21 days as a treatment cycle. After 4~6 cycles, Penpulimab injection, 21 days as a treatment cycle.
Intervention Type
Drug
Intervention Name(s)
TQB2618 injection, Penpulimab injection, Paclitaxel, Cisplatin or Carboplatin
Intervention Description
TQB2618 injection is an Anti TIM-3 (T-cell immunoglobulin and mucin domain-3) monoclonal antibody. Penpulimab injection is a humanized Monoclonal Antibody target Programmed Cell Death Protein 1 (PD-1). Paclitaxel is a anti-microtubule drug, which promotes tubulin polymerization, inhibits depolymerization, maintains tubulin stability and inhibits cell mitosis. Cisplatin inhibits DNA synthesis by generating in-strand interstrand crosslinking with DNA. Protein and RNA synthesis can also be inhibited. Carboplatin is a cyclic nonspecific antitumor agents that cause cross-linking between DNA strands and affect their synthesis to inhibit cancer cells.
Intervention Type
Drug
Intervention Name(s)
Penpulimab injection, Paclitaxel, Cisplatin or Carboplatin
Intervention Description
Penpulimab injection is a humanized Monoclonal Antibody target Programmed Cell Death Protein 1 (PD-1). Paclitaxel is a anti-microtubule drug, which promotes tubulin polymerization, inhibits depolymerization, maintains tubulin stability and inhibits cell mitosis. Cisplatin inhibits DNA synthesis by generating in-strand interstrand crosslinking with DNA. Protein and RNA synthesis can also be inhibited. Carboplatin is a cyclic nonspecific antitumor agents that cause cross-linking between DNA strands and affect their synthesis to inhibit cancer cells.
Primary Outcome Measure Information:
Title
Progression free survival (PFS)
Description
The time period from the first administration of the drug to disease progression or death event (whichever occurs first).
Time Frame
Baseline to up to two years.
Title
Objective response rate (ORR)
Description
According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and iRECIST, the proportion of subjects whose tumors are evaluated as complete response(CR) and partial response(PR) by subcenter imaging evaluation. It is recorded from the first administration of the drug to disease progression or initiation of a new anticancer treatment.
Time Frame
Baseline to up to two years.
Secondary Outcome Measure Information:
Title
PFS rate at 9 months
Description
Proportion of survived participants without progression at 9th months.
Time Frame
Baseline to 9 months
Title
Overall survival (OS)
Description
Time from the randomization to death from all causes.
Time Frame
Baseline to up to two years.
Title
Disease Control Rate (DCR)
Description
The percentage of participants with complete response (CR), partial response (PR), or stable disease (SD) for 6 weeks or more as determined by investigators according to RECIST 1.1.
Time Frame
Baseline to up to two years.
Title
Clinical benefit rate (CBR)
Description
The percentage of participants with complete response (CR), partial response (PR), or stable disease (SD) for 6 months or more as determined by investigators according to RECIST 1.1.
Time Frame
Baseline to up to two years.
Title
Duration of Remission (DOR)
Description
The period from firstly-recorded objective tumor response (CR or PR) to firstly-recorded objective tumor progression or death due to any cause (whichever occurs first).
Time Frame
Baseline to up to two years.
Title
Incidence of adverse events (AEs)
Description
All adverse medical events that occur after the subject receives the investigational drug may be manifested as symptoms, signs, disease, or laboratory abnormalities, but are not necessarily causally related to the investigational drug, evaluated according to the National Cancer Institute standard for common toxic criteria [NCI-CTC v5.0].
Time Frame
Baseline to up to two years.
Title
Severity of adverse events (AEs)
Description
All adverse medical events that occur after the subject receives the investigational drug may be manifested as symptoms, signs, disease, or laboratory abnormalities, but are not necessarily causally related to the investigational drug, evaluated according to the National Cancer Institute standard for common toxic reactions [NCI-CTC v5.0].
Time Frame
Baseline to up to two years.
Title
Serious adverse events (SAEs)
Description
It refers to adverse medical events such as death, life-threatening, permanent or serious disability or loss of function, hospitalization or prolonged hospitalization, and congenital abnormalities or birth defects after the subject receives the experimental drug.
Time Frame
Baseline to up to two years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The subjects voluntarily joined the study, signed the informed consent form, and had good compliance. Between the ages of 18-75 years (calculated based on the date of signing ICF); male or female; Eastern cooperative oncology group (ECOG) score 0-1; estimated survival time ≥ 3 months. No indications of local radical therapy for recurrence/metastasis head and neck squamous cell carcinoma.And histologically- or cytologically-confirmed head and neck squamous cell carcinoma ,Primary tumor locations of oropharynx, oral cavity, hypopharynx, or larynx. No systemic therapy for recurrent/metastatic lesions, but excluding systemic therapy for locally advanced disease as a part of multimodal therapy (including induction therapy, systemic therapy in the same period of radiotherapy, and adjuvant therapy), and the completion time of treatment was more than 6 months from enrollment (according to the date of informed consent); At least one measurable lesion (based on RECIST1.1). The main organs function are normally, the following criteria are met: hemoglobin (Hb) ≥90g/L (no blood transfusion and blood products within 14 days) ;absolute neutrophil count (ANC) ≥1.5×109/L; platelets (PLT) ≥90×109/L. Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN. If accompanied by liver metastases, ALT and AST ≤ 5×ULN; Serum creatinine (CR) ≤ 1.5×ULN or creatinine clearance (CCR) ≥ 60 ml/min. Prothrombin time (PT), activated partial thromboplastin time (APTT), international normalized ratio (INR) ≤ 1.5×ULN (no anticoagulant therapy); Thyroid-stimulating hormone (TSH) ≤ ULN; If abnormalities should be examined, T3 and T4 levels should be examined, and T3 and T4 levels are normal. Cardiac ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ 50%. Female participants of childbearing age should agree to use contraception (e.g., IUDs, pills, or condoms) during the study period and for 6 months after the end of the study; Have a negative serum pregnancy test within 7 days prior to study enrollment and must be a non-lactating subject; Male participants should agree that contraception must be used during the study period and for 6 months after the end of the study period. Exclusion Criteria: Comorbidity and medical history: Have had or currently have other malignant tumors within 3 years. The following two conditions can be enrolled: other malignancies treated with a single surgery to achieve 5-year disease-free survival (DFS); cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumors), Tis (carcinoma in situ) and T1 (tumor-invasive basement membrane)]; adverse effects due to any prior treatment have not been restored to CTCAE 5.0 ≤ level 1 (except for toxicity where the investigator determines that there is no safety risk); Major surgical treatment, incision biopsy, or significant traumatic injury were received within 28 days prior to study treatment Long-term unhealed wounds or fractures Arteriovenous thrombotic events within 6 months, such as cerebrovascular accidents; Those who have a history of psychotropic substance abuse and cannot quit or have a mental disorder; Subjects with any severe and/or uncontrolled medical conditions, including: Unsatisfactory blood pressure control (systolic blood pressure ≥ 150mmHg or diastolic blood pressure ≥100 mmHg); Have grade ≥2 myocardial ischemia or myocardial infarction, arrhythmias (including QTc ≥ 450 ms (male) in men and QTc ≥ 470 ms (female)) and grade ≥ congestive heart failure grade 2 (New York Heart Association (NYHA) grade); Active or uncontrolled severe infection (≥ CTC AE grade 2 infection) or unexplained fever > 38.5°C; Liver cirrhosis, active hepatitis Note: Active hepatitis (hepatitis B reference: HBsAg positive and HBV (hepatitis B virus) DNA detection value of more than 1000 copies /mL; Hepatitis C reference: HCV (hepatitis C virus) antibody positive, and HCV virus titer test value above the upper limit of normal); Known to have syphilis; Renal failure requires hemodialysis or peritoneal dialysis A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; Poor diabetes control [fasting blood glucose (FBG) > 10mmol/L] Urine routine indicated urine protein ≥++, and confirmed 24 hours urine protein quantity > 1.0 g People who have epilepsy and need treatment Tumor related symptoms and treatment Study history of surgery, chemotherapy, radiotherapy, or other anticancer therapy within 4 weeks prior to the start of treatment (washout period from the end of the last treatment); progress during or within 6 months of completion of systemic therapy (including induction therapy, concurrent radiotherapy, adjuvant therapy) for locally advanced disease; Secondary radiotherapy was performed for local recurrent lesions; Received Chinese patent drugs with anti-tumor indications specified in the Chinese National Medical Product Administration approved drug instructions within 1 week before the study treatment; Have received relevant immunotherapy drugs in the past; where imaging (CT or MRI) shows that the tumor has invaded important blood vessels, or the investigator determines that the tumor is highly likely to invade important blood vessels and cause fatal massive bleeding during the follow-up study period; Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (investigator's judgment) Subjects with known central nervous system metastatic and/or cancerous meningitis; Research and treatment related: Study history of live attenuated vaccine vaccination within 28 days before the start of treatment or planned live attenuated vaccine vaccination during the study period; Patients with a definite tendency to bleed or clinically significant bleeding symptoms, including but not limited to gastrointestinal bleeding, nasal bleeding, and hemorrhagic disease or coagulopathy within 28 days prior to initial medication; People who have experienced severe hypersensitivity after the use of monoclonal antibodies, or are allergic to known components of the drug under study; Study of active autoimmune diseases requiring systemic treatment that occurred within 2 years prior to initiation of treatment; Have been diagnosed with immunodeficiency or are receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy (dose > 10mg/ day prednisone or other efficacy hormone) and continue to use within 2 weeks before the study therapy begins; Participated in clinical trials of other antitumor drugs within 4 weeks before the first medication; Subjects who, in the judgment of the investigator, have concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study, or subjects who are not suitable for inclusion for other reasons.
Facility Information:
Facility Name
Gansu Prouincial Cancer Hospital
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Wang
Phone
+86 13893338170
Email
jack3376@126.com
Facility Name
Jiangmen Central Hospital
City
Jiangmen
State/Province
Guangdong
ZIP/Postal Code
529030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fangming Li
Phone
+86 13528342766
Email
342674168@qq.com
Facility Name
Guangxi Medical University Cancer Hospital
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Song Qu, Doctor
Phone
+86 13607887386
Email
daisyqs@163.com
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin Wu
Phone
+86 15303608800
Email
w.u-jin@163.com
Facility Name
AnYang Tumor Hospital
City
Anyang
State/Province
Henan
ZIP/Postal Code
455000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YongGui Hong
Phone
+86 13525836556
Email
hygsir168@126.com
Facility Name
The First Affiliated Hospital of Henan University of Science and Technology
City
Luoyang
State/Province
Henan
ZIP/Postal Code
471003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiye Zhang
Phone
+86 13783100985
Email
13783100985@163.com
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Zong, Doctor
Phone
+86 13523586882
Email
zonghong522@126.com
Facility Name
Zhumadian Centre Hospital
City
Zhumadian
State/Province
Henan
ZIP/Postal Code
463003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yunfang Chen
Phone
+86 13783961672
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yaqian Han
Phone
+86 18673176667
Email
hanyaqian@hnca.org.cn
Facility Name
Jiangxi Cancer Hospital
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingao Li, Doctor
Phone
+86 13970866296
Email
lijingao@hotmail.com
Facility Name
Liaoning Cancer hospital
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhendong Li, Doctor
Phone
+86 18900917937
Email
1349946150@qq.com
Facility Name
The Second Hospital Of Dalian Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
116027
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
XiuHua Sun
Phone
+86 17709873631
Email
3038668@vip.sina.com

12. IPD Sharing Statement

Learn more about this trial

A Clinical Trial of TQB2618 Injection Combined With Penpulimab Injection and Chemotherapy Versus Penpulimab Injection Combined With Chemotherapy in First-line Treatment of Relapsed/Metastatic Head and Neck Squamous Cell Carcinoma

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