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RECRUITING
NCT05182944
PHASE2

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

Sponsor: The First Affiliated Hospital of Zhengzhou University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

130

Start Date

2022-01-15

Completion Date

2027-01-15

Last Updated

2022-05-11

Healthy Volunteers

No

Interventions

DRUG

A: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

DRUG

B: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

DRUG

A: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

DRUG

B: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

Locations (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China