RecruitingPhase 3NCT06676449

TDLN-sparing RT Plus Immunotherapy and Chemotherapy in Locally Advanced ESCC

Tumor Draining Lymph Nodes Sparing Radiotherapy Plus Immunotherapy and Chemotherapy in Locally Advanced Esophageal Squamous Cell Carcinoma: a Randomized Phase III Trial


Sponsor

Fudan University

Enrollment

432 participants

Start Date

Nov 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn if immunotherapy in combination with tumor draining lymph nodes-sparing radiotherapy (TDLN-sparing RT) and chemotherapy works to treat locally advanced esophageal squamous cell cancer in adults. Researchers will compare immunotherapy in combination with TDLN-sparing RT and chemotherapy to TDLN-sparing RT and chemotherapy to see if immunotherapy works more effectively when using TDLN-sparing RT to treat locally advanced esophageal squamous cell cancer Participants will: TDLN-sparing RT for esophageal cancer 50.4Gy/28Fx Paclitaxel plus cisplatin every 3 weeks for 4 cycles PD-1 inhibitors or observation every 3 weeks for 1 year


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial studies a new radiation approach for esophageal squamous cell cancer (cancer of the swallowing tube) that intentionally spares lymph nodes near the tumor site. These lymph nodes are thought to help the immune system and immunotherapy work better. The study combines this targeted radiation with chemotherapy and immunotherapy. **You may be eligible if...** - You are 18–75 years old - You have confirmed squamous cell cancer of the esophagus - Your cancer is locally advanced (has not spread widely) - Your general performance level is good enough for treatment **You may NOT be eligible if...** - Your cancer has spread to distant organs beyond certain lymph nodes - You have had prior radiation to the chest or esophagus - You have autoimmune disease or conditions that prevent immunotherapy use - You have severe heart, lung, or liver problems - You are pregnant or breastfeeding 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

DRUGImmunotherapy

PD-1 inhibitors will be administered intravenously, a fixed dose of 200 mg, once every 3 weeks for 1 year.

DRUGchemotherapy: Paclitaxel/Cisplatin or other guideline recommended regimens

Paclitaxel 135mg/m2 d1, cisplatin 25mg/m2 d1-3, once every 3 weeks for 4 cycles. or other guideline recommended regimens

RADIATIONTDLN-sparing RT

TDLN-sparing radiotherapy 50.4Gy/28Fx.


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT06676449


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