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

University of Chinese Academy Sciences

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Esophageal Squamous Cell Carcinoma

Treatments: Drug: Paclitaxel for Injection (Albumin Bound); Drug: Carboplatin; Drug: Camrelizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT04506138

ZJCH-2020183-II-ESCC

Details and patient eligibility

About

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

Enrollment: 46 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 1 patient group

Camrelizumab plus Chemotherapy

Experimental group

Treatment:

Drug: Paclitaxel for Injection (Albumin Bound)

Drug: Camrelizumab

Drug: Carboplatin