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Circulating Tumor DNA MRD-Guided Adjuvant Therapy for Curatively Resected Locally Advanced Esophageal Squamous Cell Carcinoma

NCT06914011 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2025-12-03

No results posted yet for this study

Summary

This study was a multicenter, randomized, phase 3 trial to determine whether adjuvant chemotherapy including tisleliizumab improves recurrence-free survival compared to follow-up alone without chemotherapy in patients with curatively resected esophageal squamous cell carcinoma.

Conditions

  • Esophageal Cancer

Interventions

DRUG

Tislelizumab

* Participants who underwent upfront surgery without prior neoadjuvant therapy: * Tislelizumab 200 mg iv D1, Paclitaxel 175 mg/m2 iv D1, and Carboplatin AUC 5 mg/mL/min iv D1, in a 3-week cycle for one cycle * Concurrent radiotherapy (25 fractions of 1.8 Gy each, with 5 fractions per week) with Tislelizumab 200 mg iv D1, D22, Paclitaxel 50 mg/m2 iv D1, 8, 15, 22, 29, and Carboplatin AUC 2 mg/mL/min D1, 8, 15, 22, 29 * Tislelizumab 200 mg iv D1, Paclitaxel 175 mg/m2 iv D1, and Carboplatin AUC 5 mg/mL/min iv D1, in a 3-week cycle for 1 cycle * Tislelizumab 400 mg iv D1, in a 6-week cycle for six cycles * For participants who underwent neoadjuvant chemoradiotherapy followed by surgery will receive adjuvant chemoimmunotherapy in the following sequence: * Tislelizumab 200 mg iv D1, Paclitaxel 175 mg/m2 iv D1, and Carboplatin AUC 5 mg/mL/min iv D1, in a 3-week cycle for four cycles * Tislelizumab 400 mg iv D1, in a 6-week cycle for six cycles

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-06
Primary Completion
2031-02-28
Completion
2034-05-30

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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 NCT06914011 on ClinicalTrials.gov