RecruitingNot ApplicableNCT06401447

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

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)


Sponsor

Fudan University

Enrollment

50 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding an immunotherapy drug to a combination of chemotherapy and radiation can improve survival for people with locally advanced esophageal squamous cell carcinoma (cancer of the food tube) who cannot or choose not to have surgery. **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with stage II–IV esophageal squamous cell carcinoma (with spread limited to nearby lymph nodes at most) - Surgery is not possible or you have declined it - You are in good functional health (ECOG 0–1) - Your expected survival is more than 3 months **You may NOT be eligible if...** - You have had an esophageal or tracheal stent placed - Your tumor has invaded major blood vessels or the airway and poses a high risk of bleeding or perforation - You have had another cancer in the past 3 years - You have previously received immune checkpoint therapy (anti-PD-1/PD-L1) or similar drugs - You are currently in another clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONRadiotherapy

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


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, China

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NCT06401447


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