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Efficacy of Neoadjuvant PD-1 Blockade Plus Chemotherapy for Esophageal Squamous Cell Carcinoma

NCT04225364 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2021-02-02

No results posted yet for this study

Summary

This study aims to evaluate the efficacy of Camrelizumab plus concurrent chemotherapy as neoadjuvant approach for patients with opearble esophageal squamous cell carcinoma. In addition, potential clinical utility of ctDNA in monitoring tumor burden and dynamics of tumor clonality during neoadjuvant immunotherapy will be assessed as well. At the same time, CD8 and PD-L1 will also be used as monitoring indicators.

Conditions

Interventions

DRUG

camrelizumab

Participants will receive camrelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks for 6 weeks. Discontinuation will be considered due to toxicity, withdrawal of consent, or end of study. Every 3-week treatment period was considered to be a cycle.

DRUG

Paclitaxel for injection (albumin-bound)

Paclitaxel for injection (albumin-bound): 260mg/m2(in total), ivgtt d1, d8, q3w，for 2 cycle

DRUG

Cisplatin

75mg/m2(in total), ivgtt d1-d3, q3w, for 2 cycles

Sponsors & Collaborators

  • BGI-Shenzhen

    collaborator INDUSTRY

  • Jiangsu HengRui Medicine Co., Ltd.

    collaborator INDUSTRY

  • Guangzhou Institute of Respiratory Disease

    lead OTHER

Principal Investigators

  • Jun liu, Ph.D, M.D · The First Affiliated Hospital of Guangzhou Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
17 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-17
Primary Completion
2021-01-15
Completion
2021-01-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04225364 on ClinicalTrials.gov