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 — DRUGanti-PD-L1 immunotherapy
- Nab paclitaxel — DRUGchemotherapy
- Carboplatin — DRUGchemotherapy
- radiation — RADIATIONradiation
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 AInduction 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 BCRT + 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
- Wencheng Zhang, MD02223340123
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