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

Sponsor
Asan Medical Center
Study ID
NCT06914011
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tislelizumab — DRUG
    1. Option 1: adjuvant chemoradioimmunotherapy in the following sequence: * Cycle 1: 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 * Cycle 2: 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 * Cycle 3: 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 * Cycles 4-9: Tislelizumab 400 mg iv D1, in a 6-week cycle for six cycles 2. Option 2: adjuvant chemoimmunotherapy in the following sequence: * Cycles 1-4: 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 * Cycles 5-10: Tislelizumab 400 mg iv D1, in a 6-week cycle for six cycles

Study Details

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.

Key Dates

Start date
May 6, 2026
Status verified
May 2026
Primary completion
Jun 28, 2031
Completion
May 30, 2034

Study Design

Enrollment
172 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Adjuvant therapy arm
    For participants assigned the adjuvant therapy arm, those who underwent neoadjuvant chemoradiotherapy followed by surgery will receive adjuvant chemoimmunotherapy. For patients who underwent neoadjuvant chemotherapy followed by surgery, or upfront surgery without prior neoadjuvant therapy, the choice between Option 1 (adjuvant chemoradioimmunotherapy) and Option 2 (adjuvant chemoimmunotherapy) will be made at the investigator's discretion. Adjuvant chemoradioimmunotherapy.
  • No Intervention: Surveillance arm
    Surveillance arm will be followed up without any adjuvant therapy, undergoing CT scans every 12 weeks during the first 2 years after randomization, and thereafter every 24 weeks until 5 years after randomization

Primary Outcome Measure

Recurrence-free survival as assessed by the investigator [ Time Frame: For 5 years after randomization ]

Central Contacts

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