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RECRUITING
NCT06843889
PHASE2

A Phase II Study of Toripalimab Combined With Sequential Neoadjuvant Chemoradiotherapy in Patients With Esophageal Squamous Cell Carcinoma

Sponsor: Nanfang Hospital, Southern Medical University

View on ClinicalTrials.gov

Summary

This was a single-center, open phase II clinical study. 34 patients with resectable local middle and advanced esophageal squamous cell carcinoma were treated with anti-PD-1 antibody combined with sequential chemoratherapy regimen: Phase I:Toripalimab (240mg day1, Q3W\*2cycle) + clinical routine chemotherapy regimen selected by the investigator; The second stage: Toripalimab (240mg day1, Q3W\*1cycle) + radiotherapy (intensity modulated radiotherapy, 40Gy/20F, 2Gy/F); Surgery was performed 4-6 weeks after completion, and subsequent treatment options were considered after surgery according to MDT discussion. According to the postoperative pathological results, the pathological complete response (pCR) and major response (MPR) were evaluated. The disease-free survival (DFS), overall survival (OS), 1 or 2 years survival rate and adverse reactions were recorded.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

34

Start Date

2025-04-03

Completion Date

2028-08-01

Last Updated

2025-04-16

Healthy Volunteers

No

Interventions

DRUG

Toripalimab (240mg day1, Q3W*3cycle)

Phase 1: Toripalimab (240mg day1, Q3W\*2cycle) + investigator's choice of clinical conventional chemotherapy; Phase 2: Toripalimab (240mg day1, Q3W\*1cycle) + radiotherapy (intensity modulated radiotherapy, 40Gy/20F, 2Gy/F); Surgery was performed 4-6 weeks after completion, and subsequent treatment options were considered after surgery according to MDT discussion.

Locations (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Baiyun District, China