NCT04506138Active, not recruitingPhase 1
Camrelizumab in Combination With Neoadjuvant Chemotherapy for Resectable Thoracic Esophageal Squamous Cell Carcinoma
Zhejiang Cancer Hospital1 site in 1 country46 target enrollmentStarted: August 11, 2020Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Zhejiang Cancer Hospital
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Major Pathologic Response (MPR)
Study Overview
Brief Summary
This study aims to evaluate the efficacy of Camrelizumab with neoadjuvant chemotherapy for resectable thoracic esophageal squamous cell carcinoma
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
Camrelizumab plus Chemotherapy
Experimental
Intervention: Camrelizumab (Drug)
Camrelizumab plus Chemotherapy
Experimental
Intervention: Paclitaxel for Injection (Albumin Bound) (Drug)
Camrelizumab plus Chemotherapy
Experimental
Intervention: Carboplatin (Drug)
Outcomes
Primary Outcomes
Major Pathologic Response (MPR)
Time Frame: 12 weeks
Pathologic complete remission (PCR)
Time Frame: 12 weeks
Secondary Outcomes
- Overall Survival (OS)(5 years)
- Event Free Survival（EFS）(5 years)
Investigators
Chenqixun
Director of Thoracic Surgery Department
Zhejiang Cancer Hospital
Study Sites (1)
Loading locations...
Similar Trials
Recruiting
Phase 2
Neoadjuvant Therapy of Camrelizumab Combined With Chemotherapy for Resectable Locally Advanced Esophageal Squamous Cell CarcinomaEsophageal CarcinomaNCT05476380Tianjin Medical University Cancer Institute and Hospital39
Recruiting
Phase 3
Camrelizumab Plus Neoadjuvant Chemotherapy or Chemoradiotherapy Versus Chemoradiotherapy in Resectable ESCC.Resectable Esophageal Squamous Cell CarcinomaNCT05043688Zhigang Li426
Recruiting
Phase 2
Phase Ⅱ Trial of Camrelizumab in Patients Without Distant Metastasis Nasopharyngeal CarcinomaDisease-free Survival RateNCT04782765Tianjin Medical University Cancer Institute and Hospital59
Recruiting
Phase 2
Neoadjuvant Camrelizumab Combined With Chemotherapy for Resectable Stage IIIA-IIIB NSCLCIMMUNOTHERAPYNeoadjuvant TherapyResectable Lung Non-Small Cell CarcinomaBiomarkers / BloodNCT06241807Shandong Cancer Hospital and Institute30
Completed
Phase 2
Efficacy of Neoadjuvant PD-1 Blockade Plus Chemotherapy for Esophageal Squamous Cell CarcinomaEsophageal Squamous Cell CarcinomaImmunotherapyNCT04225364Guangzhou Institute of Respiratory Disease56