Camrelizumab Combined With Chemoradiotherapy in Advanced Esophageal Cancer.

Sponsor

Fujian Cancer Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05624099

Collaborator

(none)

226

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This is a randomized, open, parallel controlled clinical study. Patients with advanced esophageal cancer who have not received any previous systemic antitumor therapy for esophageal cancer were selected to compare the efficacy and safety of camrelizumab combined with chemoradiotherapy versus camrelizumab combined with chemotherapy.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Neoplasms Esophageal Diseases Digestive System Neoplasms	Drug: Camrelizumab Drug: Paclitaxel Drug: Platinum Radiation: Radiotherapy	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

226 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Prospective, Open-label Clinical Study on the First-line Treatment of Advanced Esophageal Squamous Cell Carcinoma With Camrelizumab Combined With Chemoradiotherapy

Anticipated Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Camrelizumab and chemoradiotherapy	Drug: Camrelizumab 200mg i.v. d1 q3w Drug: Paclitaxel 150mg/m^2 d1 q3w Drug: Platinum Carboplatin, cisplatin and other platinum Radiation: Radiotherapy 5000cGy/30f
Active Comparator: Camrelizumab and chemotherapy	Drug: Camrelizumab 200mg i.v. d1 q3w Drug: Paclitaxel 150mg/m^2 d1 q3w Drug: Platinum Carboplatin, cisplatin and other platinum

Arm

Intervention/Treatment

Experimental: Camrelizumab and chemoradiotherapy

Drug: Camrelizumab

200mg i.v. d1 q3w

Drug: Paclitaxel

150mg/m^2 d1 q3w

Drug: Platinum

Carboplatin, cisplatin and other platinum

Radiation: Radiotherapy

5000cGy/30f

Active Comparator: Camrelizumab and chemotherapy

Drug: Camrelizumab

200mg i.v. d1 q3w

Drug: Paclitaxel

150mg/m^2 d1 q3w

Drug: Platinum

Carboplatin, cisplatin and other platinum

Outcome Measures

Primary Outcome Measures

Objective Response Rate(ORR) [3 years]
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) [3 years]
Defined as the time from the enrollment to death from any cause
Progression free survival(PFS) [3 years]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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 or advanced after surgical resection (8th edition, 2017) with UICC/AJCC TNM stage cT4N0-2M0, c any TN3M0, or c any T any NM1(clinical stage IV);
Patients with recurrent esophageal cancer after treatment without immunotherapy;
Age 18-70;
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.