Application of Toripalimab as Adjuvant Therapy After Esophageal Cancer Surgery: A Multicenter Clinical Trial

Sponsor
Henan Cancer Hospital
Study ID
NCT07332221
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Toripalimab monotherapy — DRUG
    Toripalimab monotherapy as maintenance treatment

Study Details

This study is a prospective, multicenter, multi-cohort Phase III clinical trial. It primarily enrolls high-risk recurrent esophageal cancer patients who have undergone R0 resection after neoadjuvant chemoimmunotherapy. Eligible patients are stratified based on pathological lymph node status and receive either toripalimab monotherapy as maintenance treatment or clinical observation only.

Key Dates

First listed
Jan 12, 2026
Start date
Jan 20, 2026
Status verified
Jan 2026
Primary completion
Oct 1, 2029
Completion
Oct 1, 2031

Study Design

Enrollment
435 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ypN+，receive toripalimab monotherapy as maintenance treatment
    R0 resection for esophageal cancer, ypN+
  • Experimental: ypN-，receive toripalimab monotherapy as maintenance treatment
    R0 resection for esophageal cancer, ypN-，receive toripalimab monotherapy as maintenance treatment
  • No Intervention: ypN-，clinical observation only
    R0 resection for esophageal cancer, ypN-，no further treatment

Primary Outcome Measure

2-year OS [ Time Frame: every 3 months for 2 years ]

Central Contacts

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