Induction Immuno-chemotherapy and Concurrent Chemoradiotherapy With or Without Apatinib in Unresectable, Locally Advanced Esophageal Squamous Cell Carcinoma

Sponsor
Sun Yat-sen University
Study ID
NCT06281886
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Efficacy
  • Esophageal Squamous Cell Carcinoma
  • Toxicity

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Induction Immunotherapy-Toripalimab — DRUG
    Toripalimab 240mg iv. drip, Q3W, 2 cycles
  • Induction Chemotherapy-Albumin-paclitaxel combined with cisplatin — DRUG
    Albumin-paclitaxel 260 mg/m2, administered on day 1, combined with cisplatin 25 mg/m2, administered on day 1,2,3.
  • Radiotherapy — RADIATION
    Thoracic radiotherapy at a total dose of 50Gy was delivered using the intensity modulated radiation therapy technique.
  • Apatinib — DRUG
    Oral apatinib 250mg once daily during induction therapy and concurrent chemoradiotherapy.
  • Capecitabine — DRUG
    Oral capecitabine 1000 mg/m2, twice daily, on days 1-14, every 3 weeks, concurrently with radiotherapy

Study Details

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

Key Dates

Start date
Dec 1, 2023
Status verified
Nov 2025
Primary completion
Dec 1, 2026
Completion
Dec 1, 2026

Study Design

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

Arms

  • Experimental: The study group
    Patients are planned to receive 2 cycles of induction immuno-chemotherapy plus apatinib, followed by concurrent chemoradiotherapy plus apatinib.
  • Active Comparator: The control group
    Patients are planned to receive 2 cycles of induction immuno-chemotherapy, followed by concurrent chemoradiotherapy.

Primary Outcome Measure

Progression free survival rate [ Time Frame: 1 year ]

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