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NCT04506138 Clinical Trial

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

Esophageal Squamous Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04506138
Other study ID # ZJCH-2020183-II-ESCC
Secondary ID
Status Active, not recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date August 11, 2020
Est. completion date December 31, 2025

Study information
Verified date December 2021
Source Zhejiang Cancer Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 46
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Camrelizumab
Camrelizumab 200mg D1, D22
• Paclitaxel for Injection (Albumin Bound)
Paclitaxel for Injection (Albumin Bound) 100mg/m^2 D1, D8, D22, D29
• Carboplatin
Carboplatin AUC5 D1, D22

Locations
Country Name City State
China Zhejiang Cancer Hospital Hangzhou Zhejiang

Sponsors (1)
Lead Sponsor Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Other EQ-5D-3L questionnaire 5 years
Other FACT-E questionnaire Functional Assessment of Cancer Therapy for patients with esophageal cancer questionnaire - version 4 (FACT-E) 5 years
Primary Pathologic complete remission (PCR) 12 weeks
Primary Major Pathologic Response (MPR) 12 weeks
Secondary Overall Survival (OS) 5 years
Secondary Event Free Survival(EFS) 5 years
See also
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Completed NCT02399306 - Chemoradiotherapy With or Without Enteral Nutrition for Locally Advanced Thoracic Esophageal Carcinoma Phase 3
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Not yet recruiting NCT05552651 - Envafolimab Combined With Chemotherapy in Neoadjuvant Therapy for Resectable Esophageal Squamous Cell Carcinoma Phase 2
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Terminated NCT03251417 - Apatinib and Irinotecan Combination Treatment in Unresectable or Metastatic Esophageal Squamous Cell Carcinoma Phase 2
Recruiting NCT05990231 - Cadonilimab/Anlotinib in Locally Advanced or Relapsed/Metastatic ESCC Patients After Failure of PD-1 Combined With Platinum-containing Chemotherapy Phase 2
Recruiting NCT04644250 - Combination of Toripalimab and Neoadjuvant Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma Phase 2
Completed NCT02916511 - Study of Extensive Clinical Target Volumes in Postoperative Radiotherapy Concurrent With Chemotherapy for Esophageal Squamous Cell Carcinoma Phase 2
Terminated NCT04032704 - A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors Phase 2