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Tislelizumab Combined APF Chemotherapy in the Treatment of Locally Advanced Head and Neck Tumors

Primary Purpose

Head and Neck Tumors

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Tislelizumab, Paclitaxel (albumin-bound type), Cisplatin, 5-FU
Sponsored by
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Tumors focused on measuring Immune checkpoint inhibitors, Chemotherapy, Locally advanced head and neck tumors, Induction therapy

Eligibility Criteria

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

Inclusion Criteria: Age 18-75 years old; Histological or cytology-confirmed head and neck tumors (including oral, oropharynx, hypopharynx, larynx) squamous cell carcinoma, etc.; Have at least one radiographically measurable lesion (RECIST 1.1 criteria); The clinical stage is III-IVb; There are tumor samples that can detect gene expression; ECOG score 0-1 points; Have not received radiotherapy and chemotherapy or other anti-tumor drugs before; The following hematological indicators need to be met: (1) Neutrophil count≥ 1.5×109/L; (2) Hemoglobin≥ 10g/dL; (3) Platelet count ≥ 100×109/L The following biochemical indicators need to be met: (1) Total bilirubin ≤1.5× upper limit of normal value (ULN); (2) AST and ALT < 1.5 ×ULN; (3) Creatinine clearance ≥ 60ml/min; (4) Alkaline phosphatase ≤ 5 times ULN; (5) Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤1.5xULN (for anticoagulation at a stable dose such as low molecular weight heparin or warfar.) LIN and INR can be screened within the expected therapeutic range of anticoagulants) Subjects of childbearing age need to take appropriate protective measures (contraceptive measures) before enrollment and in trials administration or other methods of birth control); Have signed informed consent; Ability to follow study protocols and follow-up procedures. Exclusion Criteria: Received anti-tumor treatment in the past 6 months, including radiotherapy and chemotherapy, surgery, immunotherapy Wait; Previously or concurrently suffering from other malignant tumors (except for malignant tumors that have been cured and survived for more than 5 years without cancer, such as skin basal cell carcinoma, cervical carcinoma in situ, superficial bladder cancer, and thyroid papillary carcinoma, etc.); There is distant metastasis; Active autoimmune diseases, history of autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); but excludes autoimmune-mediated hypothyroidism on stable doses of thyroid replacement hormone; type 1 diabetes on stable doses of insulin; vitiligo or resolved childhood asthma/allergies, Patients who do not require any intervention after adulthood; Known history of primary immunodeficiency (including positive HIV test, or suffering from other acquired or congenital immunodeficiency diseases, or history of organ transplantation and allogeneic bone marrow transplantation); Severe infection (CTC AE>2 grade) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia requiring hospitalization, bacteremia, infection complications, etc.; baseline chest imaging examination showed active lung Inflammation, symptoms and signs of infection within 2 weeks before the first use of the study drug or the need for oral or intravenous antibiotic treatment (excluding prophylactic use of antibiotics); The subject has severe liver and kidney dysfunction, HIV infection, HCV infection, uncontrolled clinical symptoms or diseases of the heart, such as: heart failure above NYHA grade II or echocardiography showing left ventricular ejection fraction (LVEF) < 50%; unstable angina; myocardial infarction within 1 year; patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention (including QTc interval ≥ 470 ms); uncontrolled diabetes, uncontrolled Patients with high blood pressure, hypertensive crisis or hypertensive encephalopathy or other diseases considered by the researchers to be ineligible; Patients with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) DNA exceeding 500 IU/ml, or patients with active hepatitis C virus (HCV) should be excluded; inactive hepatitis B surface Antigen carriers, treated and stable hepatitis B patients (HBV DNA<500IU/ml), and cured hepatitis C patients can be enrolled; Have a history of interstitial lung disease (excluding radiation pneumonitis that has not been treated with hormones) and non-infectious pneumonia; Active tuberculosis infection was found through medical history or CT examination, or patients with a history of active tuberculosis infection within 1 year before enrollment, or patients with a history of active tuberculosis infection more than 1 year ago but without formal treatment; Patients who have received any of the following treatments (1) Subjects who need to be given corticosteroids (> 10 mg prednisone equivalent dose per day) or other immunosuppressants for systemic treatment within 2 weeks before the first use of the study drug, except for local inflammation and prevention of allergies and nausea, Cases of use of corticosteroids for vomiting. In the absence of active autoimmune disease, corticosteroid replacement with inhaled or topical steroids and curative doses of prednisone >10 mg/day is permitted; (2) Have been vaccinated against tumors; those who have been vaccinated or have been vaccinated with live vaccines within 4 weeks before the first administration of the study drug; (3) Received major surgery or severe trauma within 4 weeks before the first use of the study drug; (4) Enrolled in another clinical study at the same time; Pregnant and lactating women. Women of childbearing age must take a pregnancy test within 7 days before enrollment Negative; Substance abuse, clinical or psychological or social factors that hinder informed consent or research conduct influences; Those who may be allergic to the study drug; Those who cannot perform radiotherapy and chemotherapy due to social or geographical factors; Significant weight loss within 6 weeks before enrollment (weight loss ≥ 10%); Any uncertain factors affecting the safety or compliance of the subjects; Contraindications to hormone use.

Sites / Locations

  • Department of Oncology, Drum Tower Hospital, Nanjing University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

immunotherapy combined with chemotherapy

Arm Description

Outcomes

Primary Outcome Measures

Change of pathological examination
Changes in pathologic examination before treatment and after 3-cycle induction therapy were evaluated to derive the number and proportion of patients with pathological complete remission
Change of tumor size
imaging (MRI or CT) assessment according to RECIST v1.1 was performed and documented during follow-up as required

Secondary Outcome Measures

Security assessment
according to the NCI-CTCAE 4.0 adverse reaction evaluation criteria

Full Information

First Posted
January 17, 2023
Last Updated
February 24, 2023
Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT05758389
Brief Title
Tislelizumab Combined APF Chemotherapy in the Treatment of Locally Advanced Head and Neck Tumors
Official Title
A Prospective Single-center, Single-arm Clinical Study of the PD-1 Inhibitor Tislelizumab Combined With APF Sequential Surgery or Radical Concurrent Chemoradiotherapy in the Treatment of Locally Advanced Head and Neck Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 3, 2022 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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
The goal of this clinical trial is to test in describe participant population. The main questions it aims to answer are: evaluate the efficacy and safety of tislelizumab combined with APF sequential surgery or radical concurrent chemoradiotherapy in the treatment of locally advanced head and neck tumors. the exploration of efficacy-related immune microenvironment genes Participants will receive tislelizumab combined with APF sequential surgery or radical concurrent chemoradiotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Tumors
Keywords
Immune checkpoint inhibitors, Chemotherapy, Locally advanced head and neck tumors, Induction therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
immunotherapy combined with chemotherapy
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tislelizumab, Paclitaxel (albumin-bound type), Cisplatin, 5-FU
Intervention Description
evaluate the efficacy and safety of immunotherapy combined with chemotherapy
Primary Outcome Measure Information:
Title
Change of pathological examination
Description
Changes in pathologic examination before treatment and after 3-cycle induction therapy were evaluated to derive the number and proportion of patients with pathological complete remission
Time Frame
Change from Baseline pathologic examination at the end of Cycle 3 (each cycle is 21 days)
Title
Change of tumor size
Description
imaging (MRI or CT) assessment according to RECIST v1.1 was performed and documented during follow-up as required
Time Frame
Change from baseline tumor size at the end of Cycle 3 (each cycle is 21 days)
Secondary Outcome Measure Information:
Title
Security assessment
Description
according to the NCI-CTCAE 4.0 adverse reaction evaluation criteria
Time Frame
At the end of Cycle 3 (each cycle is 21 days)

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: Age 18-75 years old; Histological or cytology-confirmed head and neck tumors (including oral, oropharynx, hypopharynx, larynx) squamous cell carcinoma, etc.; Have at least one radiographically measurable lesion (RECIST 1.1 criteria); The clinical stage is III-IVb; There are tumor samples that can detect gene expression; ECOG score 0-1 points; Have not received radiotherapy and chemotherapy or other anti-tumor drugs before; The following hematological indicators need to be met: (1) Neutrophil count≥ 1.5×109/L; (2) Hemoglobin≥ 10g/dL; (3) Platelet count ≥ 100×109/L The following biochemical indicators need to be met: (1) Total bilirubin ≤1.5× upper limit of normal value (ULN); (2) AST and ALT < 1.5 ×ULN; (3) Creatinine clearance ≥ 60ml/min; (4) Alkaline phosphatase ≤ 5 times ULN; (5) Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤1.5xULN (for anticoagulation at a stable dose such as low molecular weight heparin or warfar.) LIN and INR can be screened within the expected therapeutic range of anticoagulants) Subjects of childbearing age need to take appropriate protective measures (contraceptive measures) before enrollment and in trials administration or other methods of birth control); Have signed informed consent; Ability to follow study protocols and follow-up procedures. Exclusion Criteria: Received anti-tumor treatment in the past 6 months, including radiotherapy and chemotherapy, surgery, immunotherapy Wait; Previously or concurrently suffering from other malignant tumors (except for malignant tumors that have been cured and survived for more than 5 years without cancer, such as skin basal cell carcinoma, cervical carcinoma in situ, superficial bladder cancer, and thyroid papillary carcinoma, etc.); There is distant metastasis; Active autoimmune diseases, history of autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); but excludes autoimmune-mediated hypothyroidism on stable doses of thyroid replacement hormone; type 1 diabetes on stable doses of insulin; vitiligo or resolved childhood asthma/allergies, Patients who do not require any intervention after adulthood; Known history of primary immunodeficiency (including positive HIV test, or suffering from other acquired or congenital immunodeficiency diseases, or history of organ transplantation and allogeneic bone marrow transplantation); Severe infection (CTC AE>2 grade) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia requiring hospitalization, bacteremia, infection complications, etc.; baseline chest imaging examination showed active lung Inflammation, symptoms and signs of infection within 2 weeks before the first use of the study drug or the need for oral or intravenous antibiotic treatment (excluding prophylactic use of antibiotics); The subject has severe liver and kidney dysfunction, HIV infection, HCV infection, uncontrolled clinical symptoms or diseases of the heart, such as: heart failure above NYHA grade II or echocardiography showing left ventricular ejection fraction (LVEF) < 50%; unstable angina; myocardial infarction within 1 year; patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention (including QTc interval ≥ 470 ms); uncontrolled diabetes, uncontrolled Patients with high blood pressure, hypertensive crisis or hypertensive encephalopathy or other diseases considered by the researchers to be ineligible; Patients with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) DNA exceeding 500 IU/ml, or patients with active hepatitis C virus (HCV) should be excluded; inactive hepatitis B surface Antigen carriers, treated and stable hepatitis B patients (HBV DNA<500IU/ml), and cured hepatitis C patients can be enrolled; Have a history of interstitial lung disease (excluding radiation pneumonitis that has not been treated with hormones) and non-infectious pneumonia; Active tuberculosis infection was found through medical history or CT examination, or patients with a history of active tuberculosis infection within 1 year before enrollment, or patients with a history of active tuberculosis infection more than 1 year ago but without formal treatment; Patients who have received any of the following treatments (1) Subjects who need to be given corticosteroids (> 10 mg prednisone equivalent dose per day) or other immunosuppressants for systemic treatment within 2 weeks before the first use of the study drug, except for local inflammation and prevention of allergies and nausea, Cases of use of corticosteroids for vomiting. In the absence of active autoimmune disease, corticosteroid replacement with inhaled or topical steroids and curative doses of prednisone >10 mg/day is permitted; (2) Have been vaccinated against tumors; those who have been vaccinated or have been vaccinated with live vaccines within 4 weeks before the first administration of the study drug; (3) Received major surgery or severe trauma within 4 weeks before the first use of the study drug; (4) Enrolled in another clinical study at the same time; Pregnant and lactating women. Women of childbearing age must take a pregnancy test within 7 days before enrollment Negative; Substance abuse, clinical or psychological or social factors that hinder informed consent or research conduct influences; Those who may be allergic to the study drug; Those who cannot perform radiotherapy and chemotherapy due to social or geographical factors; Significant weight loss within 6 weeks before enrollment (weight loss ≥ 10%); Any uncertain factors affecting the safety or compliance of the subjects; Contraindications to hormone use.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Yan
Phone
+86 15805182426
Email
firefreebird@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kongcheng Wang
Phone
+86 13814165197
Email
wangxxbz@126.com
Facility Information:
Facility Name
Department of Oncology, Drum Tower Hospital, Nanjing University School of Medicine
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Yan
Phone
+86 15805182426
Email
firefreebird@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Tislelizumab Combined APF Chemotherapy in the Treatment of Locally Advanced Head and Neck Tumors

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