Comparing ICI Followed By CCRT And CCRT Followed By Immunotherapy In Unresectable LA-ESCC

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT07733830
Phase
PHASE2
Status
Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Adebrelimab — DRUG
    anti-PD-L1 immunotherapy
  • Nab paclitaxel — DRUG
    chemotherapy
  • Carboplatin — DRUG
    chemotherapy
  • radiation — RADIATION
    radiation

Study Details

A total of 120 patients with unresectable, locally advanced esophageal squamous cell carcinoma patients will be enrolled in this study and randomly divided into two groups. Arm A: After 2 cycles of induction adebrelimab plus chemotherapy, patients will be treated with concurrent chemoradiotherapy (50.4Gy/1.8Gy/28f), and adebrelimab will maintain to PD or for a maximum of 15 cycles. Arm B: Patients will be treated with concurrent chemoradiotherapy (50.4Gy/1.8Gy/28f) and adebrelimab will maintain to PD or for a maximum of 17 cycles. This study will compare the efficacy of immunotherapy in the induction and maintenance phases of radiotherapy, optimize more precise treatment plans, and potentially further increase the survival of ESCC patients.

Key Dates

First listed
Jul 29, 2026
Start date
Jul 31, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2029

Study Design

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

Arms

  • Experimental: Arm A
    Induction Immunochemotherapy + CRT 1. Induction immunochemotherapy: Nab-paclitaxel:220mg/m2,IV,d1,d22; Carboplatin:AUC=5,IV,d1,d22; Adebrelimab:1200mg, IV,d1, d22. 2. Concurrent chemoradiotherapy: Nab-paclitaxel:175mg/m2,IV,d1,d22; Carboplatin:AUC=5,IV,d1,d22; Radiotherapy:50.4Gy/1.8Gy/28f. 3. Immunotherapy maintenance: Adebrelimab:1200mg, IV,q3w, until PD or for a maximum of 15 cycles.
  • Experimental: Arm B
    CRT + Immunotherapy 1. Concurrent chemoradiotherapy: Nab-paclitaxel:175mg/m2,IV,d1,d22; Carboplatin:AUC=5,IV,d1,d22; Radiotherapy:50.4Gy/1.8Gy/28f. 2. Immunotherapy maintenance: Adebrelimab:1200mg, IV,q3w, until PD or for a maximum of 17 cycles.

Primary Outcome Measure

Progression-free survival [ Time Frame: From date of randomization until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 24 months. ]

Central Contacts

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