Back to resultsCamrelizumab in Combination With Neoadjuvant Chemotherapy for Resectable Thoracic Esophageal Squamous Cell Carcinoma
Primary Purpose
Esophageal Squamous Cell Carcinoma
Status
Active
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Camrelizumab
Paclitaxel for Injection (Albumin Bound)
Carboplatin
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma
Eligibility Criteria
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
Sites / Locations
- Zhejiang Cancer Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Camrelizumab plus Chemotherapy
Arm Description
Outcomes
Primary Outcome Measures
Pathologic complete remission (PCR)
Major Pathologic Response (MPR)
Secondary Outcome Measures
Overall Survival (OS)
Event Free Survival（EFS）
Full Information
NCT ID
NCT04506138
First Posted
August 5, 2020
Last Updated
December 12, 2021
Sponsor
Zhejiang Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04506138
Brief Title
Camrelizumab in Combination With Neoadjuvant Chemotherapy for Resectable Thoracic Esophageal Squamous Cell Carcinoma
Official Title
Camrelizumab in Combination With Neoadjuvant Chemotherapy for Resectable Thoracic Esophageal Squamous Cell Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 11, 2020 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang Cancer Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study aims to evaluate the efficacy of Camrelizumab with neoadjuvant chemotherapy for resectable thoracic esophageal squamous cell carcinoma
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Camrelizumab plus Chemotherapy
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Camrelizumab
Intervention Description
Camrelizumab 200mg D1, D22
Intervention Type
Drug
Intervention Name(s)
Paclitaxel for Injection (Albumin Bound)
Intervention Description
Paclitaxel for Injection (Albumin Bound) 100mg/m^2 D1, D8, D22, D29
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin AUC5 D1, D22
Primary Outcome Measure Information:
Title
Pathologic complete remission (PCR)
Time Frame
12 weeks
Title
Major Pathologic Response (MPR)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Time Frame
5 years
Title
Event Free Survival（EFS）
Time Frame
5 years
Other Pre-specified Outcome Measures:
Title
EQ-5D-3L questionnaire
Time Frame
5 years
Title
FACT-E questionnaire
Description
Functional Assessment of Cancer Therapy for patients with esophageal cancer questionnaire - version 4 (FACT-E)
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Camrelizumab in Combination With Neoadjuvant Chemotherapy for Resectable Thoracic Esophageal Squamous Cell Carcinoma
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