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

Phase 1
Active, not recruiting
Conditions
Esophageal Squamous Cell Carcinoma
Interventions
Registration Number
NCT04506138
Lead Sponsor
Zhejiang Cancer Hospital
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
46
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

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Camrelizumab plus ChemotherapyPaclitaxel for Injection (Albumin Bound)-
Camrelizumab plus ChemotherapyCamrelizumab-
Camrelizumab plus ChemotherapyCarboplatin-
Primary Outcome Measures
NameTimeMethod
Pathologic complete remission (PCR)12 weeks
Major Pathologic Response (MPR)12 weeks
Secondary Outcome Measures
NameTimeMethod
Overall Survival (OS)5 years
Event Free Survival(EFS)5 years

Trial Locations

Locations (1)

Zhejiang Cancer Hospital

🇨🇳

Hangzhou, Zhejiang, China

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