NCT06303583

Neoadjuvant Chemoradiotherapy Followed by Sequential Immunotherapy for Thoracic Esophageal Squamous Cell Carcinoma

• Status: Enrolling By Invitation
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Qiu Guoqin · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of study is to investigate the safety and efficacy of sequential immunotherapy with neoadjuvant chemoradiotherapy for esophageal cancer

Detailed description

This is a single-arm, phase Ib study. Eligibility criteria include histologically confirmed ESCC and clinical T3-4aN0M0 or T2-4aN+M0 (AJCC/UICC 8). Patients received neoadjuvant radiotherapy (41.4Gy in 23 fractions) with concurrent chemotherapy (paclitaxel, 50 mg/m2, carboplatin area under the curve of 2mg/mL/min, QW\*5). Then followed by two cycles of tislelizumab (200mg, Q3W). The primary endpoint was the pathological complete response (pCR) rate and safety.

Conditions

• Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	paclitaxel	paclitaxel, 50 mg/m2, QW\*5
DRUG	carboplatin	area under the curve of2mg/mL/min, QW\*5
DRUG	tislelizumab	200mg Q3W, 2cycles
RADIATION	radiotherapy	41.4Gy in 23 fractions

Timeline

• Start date: 2022-06-01
• Primary completion: 2024-08-31
• Completion: 2026-12-31
• First posted: 2024-03-12
• Last updated: 2024-03-12

Locations

1 site across 1 country: China