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Camrelizumab Combined With Chemoradiotherapy in Advanced Esophageal Cancer.

Primary Purpose

Esophageal Neoplasms, Esophageal Diseases, Digestive System Neoplasms

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
camrelizumab
Paclitaxel drugs
Platinum drug
Radiation
Sponsored by
Fujian Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Neoplasms focused on measuring Immunotherapy, Platinum, radiotherapy, Paclitaxel

Eligibility Criteria

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

Inclusion Criteria: Sign written informed consent and voluntarily participate in this study; Patients with esophageal squamous cell carcinoma confirmed by histopathology and/or immunohistochemistry (8th edition 2017) had UICC/AJCC TNM stage IVA or oligometastatic stage IVB; Survival is expected to exceed 3 months Age 18-75; ECOG PS 0-2 Never received any systemic anti-tumor therapy for esophageal cancer, including radiotherapy, chemotherapy, targeted and immunotherapy; Have at least one measurable lesion Normal function of major organs, including: Routine blood test (no blood components, cell growth factors, whitening drugs, platelet raising drugs, and anemia correcting drugs are allowed within 14 days before the first use of study drugs) White blood cell count ≥ 3.0×10^9/L Neutrophil count ≥ 1.0×10^9/L Platelet count ≥ 80×109/L Hemoglobin ≥ 80 g/L Blood biochemical examination: Total bilirubin ≤ 1.5×ULN ALT ≤2.5×ULN, AST ≤2.5×ULN, Serum creatinine ≤ 1.5×ULN, or creatinine clearance ≥ 45mL/min Subjects have good compliance and cooperate with follow-up Exclusion Criteria: The presence of uncontrollable pleural effusion, pericardial effusion or ascites that require repeated drainage; Poor nutritional status, BMI < 18.5 Kg/m^2; If symptomatic nutritional support was corrected before randomization, enrollment could be considered after evaluation by the principal investigator; Gastrointestinal bleeding (bleeding volume > 200ml/ day); Patients with deep ulcers as determined by the investigator; Previous allergy to monoclonal antibodies, any component of camrelizumab, paclitaxel, cisplatin or other platinum-based drugs; Has received or is receiving any of the following medical treatment: any radiation, chemotherapy or other antitumor drugs for the tumor; Being treated with immunosuppressive agents or systemic hormones for immunosuppression purposes (dose >10mg/ day prednisone or equivalent) within 2 weeks prior to the first use of the study drug; In the absence of active autoimmune disease, inhaled or topical steroids and adrenocorticosteroid replacement at a dose of >10mg/ day or its equivalent are permitted; Received live attenuated vaccine within 4 weeks before the first administration of the study drug; Major surgery or severe trauma within 4 weeks before the first use of the study drug; A history of any active autoimmune disease or autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (which may be considered for inclusion after hormone replacement therapy); Patients with complete remission of psoriasis or childhood asthma/allergies who did not require any intervention as adults were considered for inclusion, but patients requiring medical intervention with bronchodilators were not included; A history of immunodeficiency, including being HIV positive, or suffering from another acquired or congenital immunodeficiency disease, or a history of organ transplantation or allogeneic bone marrow transplantation; The presence of poorly controlled cardiac clinical symptoms or diseases, including but not limited to: Such as (1) NYHAII grade or above heart failure; (2) unstable angina pectoris; (3) myocardial infarction occurred within 1 year; (4) Clinically significant supraventricular or ventricular arrhythmias are not well controlled without clinical intervention or after clinical intervention; Severe infection (CTCAE > 2) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, infection complications requiring hospitalization; Baseline chest imaging examination indicated active pulmonary inflammation, signs and symptoms of infection within 14 days before the first use of study drugs, or the need for oral or intravenous antibiotic treatment, except for prophylactic antibiotic use; Patients with active pulmonary tuberculosis infection found by medical history or CT examination, or with a history of active pulmonary tuberculosis infection within 1 year before enrollment, or with a history of active pulmonary tuberculosis infection more than 1 year ago but without regular treatment; The presence of active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL) and hepatitis C (HCV antibody positive and HCV RNA above the assay limit); In the judgment of the investigator, there are other factors that may lead to the forced termination of the study, such as the presence of other serious medical conditions (including mental illness) requiring concomitant treatment, alcoholism, substance abuse, family or social factors, and factors that may affect the safety or compliance of the subjects.

Sites / Locations

  • Fujian Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

drug

Arm Description

camrelizumab 200mg intravenous drip d1q3w Paclitaxel: 150mg/m2 d1 q3w Platinum: Cisplatin, carboplatin, nedaplatin and other platinum drugs Radiotherapy dose: 5040cGy/28f radiotherapy efficacy evaluation after 2-3 cycles of chemotherapy PR/SD received local radiotherapy.

Outcomes

Primary Outcome Measures

Objective Response Rate(ORR)
ORR is determined using RECIST v1.1, defined as best overall response (CR or PR) across all assessment time points during the period from enrolment to termination of trial treatment.

Secondary Outcome Measures

Overall survival(OS)
Defined as the time from the enrollment to death from any cause
Progression free survival(PFS)
It is defined as the time from enrollment to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first.

Full Information

First Posted
November 13, 2022
Last Updated
October 17, 2023
Sponsor
Fujian Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05624099
Brief Title
Camrelizumab Combined With Chemoradiotherapy in Advanced Esophageal Cancer.
Official Title
Prospective Single-arm, Exploratory, Multicenter Phase II Clinical Study of Camrelizumab Combined With Chemoradiotherapy in the Treatment of Advanced First-line Esophageal Phosphorous Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
December 1, 2025 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fujian Cancer Hospital

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
This is a prospective single-arm exploratory clinical study. The efficacy and safety of camrelizumab combined with chemoradiotherapy and camrelizumab combined with chemotherapy were evaluated in patients with advanced esophageal cancer who had not previously received any systemic antitumor therapy for esophageal cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Neoplasms, Esophageal Diseases, Digestive System Neoplasms
Keywords
Immunotherapy, Platinum, radiotherapy, Paclitaxel

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
drug
Arm Type
Experimental
Arm Description
camrelizumab 200mg intravenous drip d1q3w Paclitaxel: 150mg/m2 d1 q3w Platinum: Cisplatin, carboplatin, nedaplatin and other platinum drugs Radiotherapy dose: 5040cGy/28f radiotherapy efficacy evaluation after 2-3 cycles of chemotherapy PR/SD received local radiotherapy.
Intervention Type
Drug
Intervention Name(s)
camrelizumab
Intervention Description
200mg intravenous drip d1q3w
Intervention Type
Drug
Intervention Name(s)
Paclitaxel drugs
Intervention Description
150mg/m2 d1 q3w
Intervention Type
Drug
Intervention Name(s)
Platinum drug
Intervention Description
Cisplatin, carboplatin, nedaplatin and other platinum drugs
Intervention Type
Radiation
Intervention Name(s)
Radiation
Intervention Description
Dose: 5040cGy/28f
Primary Outcome Measure Information:
Title
Objective Response Rate(ORR)
Description
ORR is determined using RECIST v1.1, defined as best overall response (CR or PR) across all assessment time points during the period from enrolment to termination of trial treatment.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Overall survival(OS)
Description
Defined as the time from the enrollment to death from any cause
Time Frame
3 years
Title
Progression free survival(PFS)
Description
It is defined as the time from enrollment to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first.
Time Frame
3 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: Sign written informed consent and voluntarily participate in this study; Patients with esophageal squamous cell carcinoma confirmed by histopathology and/or immunohistochemistry (8th edition 2017) had UICC/AJCC TNM stage IVA or oligometastatic stage IVB; Survival is expected to exceed 3 months Age 18-75; ECOG PS 0-2 Never received any systemic anti-tumor therapy for esophageal cancer, including radiotherapy, chemotherapy, targeted and immunotherapy; Have at least one measurable lesion Normal function of major organs, including: Routine blood test (no blood components, cell growth factors, whitening drugs, platelet raising drugs, and anemia correcting drugs are allowed within 14 days before the first use of study drugs) White blood cell count ≥ 3.0×10^9/L Neutrophil count ≥ 1.0×10^9/L Platelet count ≥ 80×109/L Hemoglobin ≥ 80 g/L Blood biochemical examination: Total bilirubin ≤ 1.5×ULN ALT ≤2.5×ULN, AST ≤2.5×ULN, Serum creatinine ≤ 1.5×ULN, or creatinine clearance ≥ 45mL/min Subjects have good compliance and cooperate with follow-up Exclusion Criteria: The presence of uncontrollable pleural effusion, pericardial effusion or ascites that require repeated drainage; Poor nutritional status, BMI < 18.5 Kg/m^2; If symptomatic nutritional support was corrected before randomization, enrollment could be considered after evaluation by the principal investigator; Gastrointestinal bleeding (bleeding volume > 200ml/ day); Patients with deep ulcers as determined by the investigator; Previous allergy to monoclonal antibodies, any component of camrelizumab, paclitaxel, cisplatin or other platinum-based drugs; Has received or is receiving any of the following medical treatment: any radiation, chemotherapy or other antitumor drugs for the tumor; Being treated with immunosuppressive agents or systemic hormones for immunosuppression purposes (dose >10mg/ day prednisone or equivalent) within 2 weeks prior to the first use of the study drug; In the absence of active autoimmune disease, inhaled or topical steroids and adrenocorticosteroid replacement at a dose of >10mg/ day or its equivalent are permitted; Received live attenuated vaccine within 4 weeks before the first administration of the study drug; Major surgery or severe trauma within 4 weeks before the first use of the study drug; A history of any active autoimmune disease or autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (which may be considered for inclusion after hormone replacement therapy); Patients with complete remission of psoriasis or childhood asthma/allergies who did not require any intervention as adults were considered for inclusion, but patients requiring medical intervention with bronchodilators were not included; A history of immunodeficiency, including being HIV positive, or suffering from another acquired or congenital immunodeficiency disease, or a history of organ transplantation or allogeneic bone marrow transplantation; The presence of poorly controlled cardiac clinical symptoms or diseases, including but not limited to: Such as (1) NYHAII grade or above heart failure; (2) unstable angina pectoris; (3) myocardial infarction occurred within 1 year; (4) Clinically significant supraventricular or ventricular arrhythmias are not well controlled without clinical intervention or after clinical intervention; Severe infection (CTCAE > 2) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, infection complications requiring hospitalization; Baseline chest imaging examination indicated active pulmonary inflammation, signs and symptoms of infection within 14 days before the first use of study drugs, or the need for oral or intravenous antibiotic treatment, except for prophylactic antibiotic use; Patients with active pulmonary tuberculosis infection found by medical history or CT examination, or with a history of active pulmonary tuberculosis infection within 1 year before enrollment, or with a history of active pulmonary tuberculosis infection more than 1 year ago but without regular treatment; The presence of active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL) and hepatitis C (HCV antibody positive and HCV RNA above the assay limit); In the judgment of the investigator, there are other factors that may lead to the forced termination of the study, such as the presence of other serious medical conditions (including mental illness) requiring concomitant treatment, alcoholism, substance abuse, family or social factors, and factors that may affect the safety or compliance of the subjects.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiancheng Li, Doctor
Phone
13906900190
Email
jianchengli6@126.com
Facility Information:
Facility Name
Fujian Cancer Hospital
City
Fuzhou
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Camrelizumab Combined With Chemoradiotherapy in Advanced Esophageal Cancer.

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