Induction Immuno-chemotherapy and Concurrent Chemoradiotherapy With or Without Apatinib in Unresectable, Locally Advanced Esophageal Squamous Cell Carcinoma
NCT06281886 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 170
Last updated 2025-11-17
Summary
This is an open-label, randomized, controlled phase II study evaluating induction immuno-chemotherapy and concurrent chemoradiotherapy with or without apatinib in unresectable, locally advanced esophageal squamous cell carcinoma
Conditions
- Esophageal Squamous Cell Carcinoma
- Efficacy
- Toxicity
Interventions
- DRUG
-
Induction Immunotherapy-Toripalimab
Toripalimab 240mg iv. drip, Q3W, 2 cycles
- DRUG
-
Induction Chemotherapy-Albumin-paclitaxel combined with cisplatin
Albumin-paclitaxel 260 mg/m2, administered on day 1, combined with cisplatin 25 mg/m2, administered on day 1,2,3.
- RADIATION
-
Radiotherapy
Thoracic radiotherapy at a total dose of 50Gy was delivered using the intensity modulated radiation therapy technique.
- DRUG
-
Apatinib
Oral apatinib 250mg once daily during induction therapy and concurrent chemoradiotherapy.
- DRUG
-
Oral capecitabine 1000 mg/m2, twice daily, on days 1-14, every 3 weeks, concurrently with radiotherapy
Sponsors & Collaborators
-
Sun Yat-sen University
lead OTHER
Principal Investigators
-
Hui Liu, Professor · Sun yat-sen universtiy cancer center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-12-01
- Primary Completion
- 2026-12-01
- Completion
- 2026-12-01
Countries
- China
Study Locations
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