Adebrelimab Plus Full-course Neoadjuvant Therapy for Resectable Locally Advanced ESCC (Phase 2)

ConditionESCC
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTianjin Medical University Cancer Institute and Hospital

About this trial

This is a prospective, single-center, randomized phase 2 study of adebrelimab plus full-course neoadjuvant therapy in resectable locally advanced esophageal squamous cell carcinoma. Patients achieving clinical complete response (cCR) after neoadjuvant treatment will be randomized 1:1 to watchful waiting with 2 cycles consolidation chemo-Immunotherapy or standard surgery. Primary endpoint is 2-year DFS. Secondary endpoints include OS, pCR/MPR, R0 resection rate, safety, and quality of life.

Eligibility criteria

Qualifiers

Patients voluntarily participate in this study, sign an informed consent form, and demonstrate good compliance;

At least 18 years of age; gender is not restricted;

ECOG performance status: 0-1;

Patients with histologically confirmed resectable esophageal squamous cell carcinoma clinically staged as (T1N+M0 or T2-4aNanyM0);

Disqualifiers

Concurrent malignant neoplasms (except for cured basal cell carcinoma of the skin);

Diagnosis of cervical esophageal cancer;

History of severe hypersensitivity reactions following administration of other monoclonal antibodies;

Presence of any active autoimmune disease or history of autoimmune disease (such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, or nephritis; asthma requiring bronchodilators for medical intervention); however, the following patients are eligible for enrollment: vitiligo, psoriasis, or alopecia not requiring systemic treatment; well-controlled type 1 diabetes; hypothyroidism with normal thyroid function following replacement therapy;

Trial design

Treatments tested in this trial

  • Combination therapy with chemotherapy and immunotherapy
  • Surgery

Treatment groups

200 Participants
are divided into 2 treatment groups

Locations

This trial has no locations