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

NCT06676449 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 432

Last updated 2026-01-07

No results posted yet for this study

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

Conditions

  • Esophageal Carcinoma
  • Radiotherapy
  • Immunotherapy

Interventions

DRUG

Immunotherapy

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

DRUG

chemotherapy: 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

RADIATION

TDLN-sparing RT

TDLN-sparing radiotherapy 50.4Gy/28Fx.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2028-10-31
Completion
2030-10-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06676449 on ClinicalTrials.gov