Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06401447
NA

TPF Concurrent Chemo-radiotherapy Plus Immunotherapy for Local Advanced Esophageal Squamous Cell Carcinoma

Sponsor: Fudan University

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn if immune microenvironment modification could improve the effect of chemoradiotherapy for patients with local advanced esophageal squamous cell carcinoma. The main questions it aims to answer are: 1. Does immune microenvironment could be modified by medium dose of three drugs (paclitaxel, cisplatin, 5-FU), PD1 checkpoint inhibitor, probiotics, and thymosin α1? 2. Does induction and consolidation of PD1 checkpoint inhibitor improve the effect of chemoradiotherapy for patients with esophageal cancer? This is a single arm study. Participants will: 1. Take one cycle of induction chemotherapy (paclitaxel, cisplatin, 5-FU) and immunotherapy (Sintilimab), two cycle of concurrent chemoradiotherapy, one cycle of consolidation chemo-immunotherapy, and then 1 year of immunotherapy. 2. Take probiotics (Clostridium Butyricum) for 1 year and thymosin alpha-1 daily during radiotherapy.

Official title: Medium Dose of Three Drugs (TPF) Concurrent Chemoradiotherapy Combined With PD-1 Checkpoint Inhibitor for Locally Advanced Esophageal Squamous Cell Carcinoma --Prospective, Single Center, Single Arm, Phase II Clinical Study (FUTURE-2)

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2023-12-01

Completion Date

2026-12-01

Last Updated

2024-05-06

Healthy Volunteers

No

Interventions

RADIATION

Radiotherapy

Simultaneously optimizing the target, dosage, and synchronized drugs for radiotherapy.

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, China