Camrelizumab in Combination With Neoadjuvant Chemotherapy for Resectable Thoracic Esophageal Squamous Cell Carcinoma

December 12, 2021 updated by: Chenqixun, Zhejiang Cancer Hospital
This study aims to evaluate the efficacy of Camrelizumab with neoadjuvant chemotherapy for resectable thoracic esophageal squamous cell carcinoma

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

46

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Zhejiang Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histological diagnosis of thoracic Esophageal squamous cell carcinoma
  • ECOG performance status 0-1
  • Age 18-75 years
  • Resectable disease, cT2-4aNanyM0 or cT1-3N+M0
  • Life expectancy more than 6 months
  • Use of an effective contraceptive for adults to prevent pregnancy

Exclusion Criteria:

  • Not suitable for surgery
  • Prior chemotherapy, radiotherapy and immune-oncology therapies for ESCC
  • Prior esophageal, gastric, or gastro-esophageal junction surgery
  • Esophageal ulcer, esophageal perforation，chest pain（≥middle level）
  • Pregnant or lactating women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Camrelizumab plus Chemotherapy
Drug: Camrelizumab
Camrelizumab 200mg D1, D22
Drug: Paclitaxel for Injection (Albumin Bound)
Paclitaxel for Injection (Albumin Bound) 100mg/m^2 D1, D8, D22, D29
Drug: Carboplatin
Carboplatin AUC5 D1, D22

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pathologic complete remission (PCR)
Time Frame: 12 weeks
12 weeks
Major Pathologic Response (MPR)
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: 5 years
5 years
Event Free Survival（EFS）
Time Frame: 5 years
5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
EQ-5D-3L questionnaire
Time Frame: 5 years
5 years
FACT-E questionnaire
Time Frame: 5 years
Functional Assessment of Cancer Therapy for patients with esophageal cancer questionnaire - version 4 (FACT-E)
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 11, 2020

Primary Completion (ANTICIPATED)

December 31, 2025

Study Completion (ANTICIPATED)

December 31, 2025

Study Registration Dates

First Submitted

August 5, 2020

First Submitted That Met QC Criteria

August 7, 2020

First Posted (ACTUAL)

August 10, 2020

Study Record Updates

Last Update Posted (ACTUAL)

December 14, 2021

Last Update Submitted That Met QC Criteria

December 12, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZJCH-2020183-II-ESCC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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