RecruitingPhase 2NCT05182944

A Study of Perioperative Camrelizumab Combined With Chemotherapy in Patients With Resectable ESCC

A Randomized, Controlled, Phase II Study of Perioperative Camrelizumab Combined With Albumin Paclitaxel and Cisplatin in Patients With Resectable Esophageal Squamous Cell Carcinoma

Sponsor

The First Affiliated Hospital of Zhengzhou University

Enrollment

130 participants

Start Date

Jan 15, 2022

Study Type

INTERVENTIONAL

Conditions

Esophageal Cancer

Summary

The purpose of this study is to observe and evaluate the efficacy and safety of camrelizumab combined with albumin paclitaxel and cisplatin as perioperative treatment of advanced esophageal squamous cell.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding camrelizumab (an immunotherapy drug) to chemotherapy given both before and after surgery improves outcomes for patients with resectable (surgically removable) squamous cell cancer of the esophagus. **You may be eligible if:** - You are between 18 and 80 years old - You have been diagnosed with squamous cell esophageal cancer confirmed by biopsy - You have not yet received any anti-cancer treatment for this cancer - Your cancer is at a stage that may be surgically removed - You are in good health (ECOG 0–1) and your organs (blood, liver, kidneys, heart, lungs) are functioning well - Your BMI is at least 18.5 **You may NOT be eligible if:** - You have previously received chemotherapy, radiation, or immunotherapy for this cancer - Your cancer has spread to distant organs - You have active autoimmune disease or are taking immune-suppressing medications - You are pregnant or breastfeeding - You have significant heart, liver, or lung problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGA：non-pCR patients

After 2 cycles of neoadjuvant therapy（Camrelizumab+Albumin Paclitaxel+Cisplatin）, non-pCR patients adjuvant treatment（2-4 cycles Camrelizumab+Albumin Paclitaxel+Cisplatin and Camrelizumab maintenance treatment） Camrelizumab, 200 mg，Intravenous injection，q3W continuous medication Albumin Paclitaxel, 125 mg/m2, Intravenous injection d1,8 q3W continuous medication Cisplatin: 75mg/m2, Intravenous injection,d1, q3W continuous medication

DRUGB：non-pCR patients

After 2 cycles of neoadjuvant therapy（Camrelizumab+Albumin Paclitaxel+Cisplatin）, non-pCR patients adjuvant treatment（Camrelizumab maintenance treatment） Camrelizumab, 200 mg，Intravenous injection，q3W continuous medication Albumin Paclitaxel, 125 mg/m2, Intravenous injection d1,8 q3W continuous medication Cisplatin: 75mg/m2, Intravenous injection,d1, q3W continuous medication

DRUGA：pCR patients

After 2 cycles of neoadjuvant therapy（Camrelizumab+Albumin Paclitaxel+Cisplatin）, pCR patients adjuvant treatment（Camrelizumab maintenance treatment） Camrelizumab, 200 mg，Intravenous injection，q3W continuous medication Albumin Paclitaxel, 125 mg/m2, Intravenous injection d1,8 q3W continuous medication Cisplatin: 75mg/m2, Intravenous injection,d1, q3W continuous medication

DRUGB：pCR patients

After 2 cycles of neoadjuvant therapy（Camrelizumab+Albumin Paclitaxel+Cisplatin）, pCR patients adjuvant treatment（Best Supportive Care） Camrelizumab, 200 mg，Intravenous injection，q3W continuous medication Albumin Paclitaxel, 125 mg/m2, Intravenous injection d1,8 q3W continuous medication Cisplatin: 75mg/m2, Intravenous injection,d1, q3W continuous medication