A Study of Camrelizumab Combined With Chemotherapy as Neoadjuvant Therapy in Adcanced Esophageal Squamous Cell Carcinoma (ESCC)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Esophageal Squamous Cell Carcinoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Patients fulfilling Eligibility Criteria will be included in our study. ESCC participants in this study will be given intravenous administration of SHR-1210 (200mg/3w) combined with albumin paclitaxel (260 mg/m2) plus carboplatin chemotherapy. Every three weeks for a cycle of treatment, which will be conducted twice, and minimally invasive surgery within 5-8 weeks after the last administration. Treatments will be administrated until disease progression, unacceptable adverse events (AE), concomitant diseases that hinder continued treatment.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 70 years
- Gender
- Both males and females
Description
Primary outcome: 1. Analysis of prognosis efficacy of patients: pathologic complete response (pCR) Secondary outcome: Overall survival(OS), Progressive-free survival(PFS), Disease control rate(DCR), Objective response rate(ORR), and the proportion of subjects who completed all treatments and radical...
Primary outcome: 1. Analysis of prognosis efficacy of patients: pathologic complete response (pCR) Secondary outcome: Overall survival(OS), Progressive-free survival(PFS), Disease control rate(DCR), Objective response rate(ORR), and the proportion of subjects who completed all treatments and radical resection (R0); Explorative outcome: To explore the efficacy of ultrasound gastroscopy, PET/CT, peripheral circulating blood tumor cell (CTC) detection and CTC-based immunofluorescence detection of PD-L1 antibody for the treatment of locally advanced ESCC with camrelizumab combined with albumin paclitaxel and platinum and potential biomarkers for predicting the efficacy of camrelizumab, including but not limited to immunohistochemical detection of PD-L1 expression in tumor specimens, T cell receptor (TCR) sequencing analysis in peripheral blood, and esophageal microbiome Analysis, etc.; patients' quality of life
Tracking Information
- NCT #
- NCT04767295
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Investigators
- Principal Investigator: wangwenxiang@hnca.org.cn wangwenxiang@hnca.org.cn Hunan Cancer Hospital
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