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

• Sponsor: Zhejiang Cancer Hospital (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04506138
• Collaborator: (none)
• Enrollment: 46
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 64.7
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

This study aims to evaluate the efficacy of Camrelizumab with neoadjuvant chemotherapy for resectable thoracic esophageal squamous cell carcinoma

Condition or Disease	Intervention/Treatment	Phase
Esophageal Squamous Cell Carcinoma	Drug: Camrelizumab; Drug: Paclitaxel for Injection (Albumin Bound); Drug: Carboplatin	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 46 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Camrelizumab in Combination With Neoadjuvant Chemotherapy for Resectable Thoracic Esophageal Squamous Cell Carcinoma
• Actual Study Start Date: Aug 11, 2020
• Anticipated Primary Completion Date: Dec 31, 2025
• Anticipated Study Completion Date: Dec 31, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Pathologic complete remission (PCR) [12 weeks]

2. Major Pathologic Response (MPR) [12 weeks]

Secondary Outcome Measures

1. Overall Survival (OS) [5 years]

2. Event Free Survival（EFS） [5 years]

Other Outcome Measures

1. EQ-5D-3L questionnaire [5 years]

2. FACT-E questionnaire [5 years]

   Functional Assessment of Cancer Therapy for patients with esophageal cancer questionnaire - version 4 (FACT-E)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhejiang Cancer Hospital	Hangzhou	Zhejiang	China	310022

Sponsors and Collaborators

• Zhejiang Cancer Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chenqixun, Director of Thoracic Surgery Department, Zhejiang Cancer Hospital
• ClinicalTrials.gov Identifier: NCT04506138
• Other Study ID Numbers: ZJCH-2020183-II-ESCC
• First Posted: Aug 10, 2020
• Last Update Posted: Dec 14, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma; Paclitaxel; Carboplatin

Study Results

No Results Posted as of Dec 14, 2021