Short-Course Definitive Chemoradiotherapy Combined With Adjuvant or Concurrent Plus Adjuvant Camrelizumab for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma

Sponsor
Ning Jiang, M.D./Ph.D.
Study ID
NCT07530094
Phase
PHASE2
Status
Recruiting
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Conditions

  • Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma

Eligibility Criteria

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

Interventions

  • Camrelizumab — BIOLOGICAL
    This study aims to compare the efficacy and safety of two novel treatment strategies-short-course definitive chemoradiotherapy combined with adjuvant camrelizumab, and short-course definitive chemoradiotherapy combined with concurrent plus adjuvant camrelizumab-in patients with locally advanced unresectable esophageal squamous cell carcinoma.

Study Details

This study aims to compare the efficacy and safety of short-course definitive concurrent chemoradiotherapy plus immunotherapy followed by immunotherapy maintenance versus short-course definitive chemoradiotherapy plus immunotherapy maintenance in the treatment of locally advanced unresectable esophageal squamous cell carcinoma, and to exploratorily identify molecular biomarkers associated with treatment efficacy and toxicity.

Key Dates

Start date
Dec 1, 2025
Status verified
Dec 2025
Primary completion
Dec 1, 2026
Completion
Dec 1, 2027

Study Design

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

Arms

  • Experimental: short-course definitive concurrent chemoradiotherapy plus immunotherapy followed by immunotherapy
    Nab-paclitaxel plus carboplatin will be administered every 3 weeks as one cycle, for a total of two cycles, concurrently with camrelizumab immunotherapy and radiotherapy (45 Gy in 18 fractions, 5 days per week, D3-D26). After completion of concurrent chemoradiotherapy plus immunotherapy, the decision to add two cycles of adjuvant chemotherapy will be made based on a comprehensive assessment of the patient's physical condition and other relevant factors. Patients will receive camrelizumab as maintenance therapy every 3 weeks for up to 12 months (a total of 17 cycles), or until disease progression, unacceptable toxicity, investigator decision, or withdrawal of consent by the patient.
  • Experimental: short-course definitive chemoradiotherapy plus immunotherapy maintenance
    Nab-paclitaxel plus carboplatin will be administered every 3 weeks as one cycle, for a total of two cycles, concurrently with radiotherapy (45 Gy in 18 fractions, 5 days per week, D3-D26). After completion of concurrent chemoradiotherapy, the decision to add two cycles of adjuvant chemotherapy will be made based on an overall assessment of the patient's physical condition and other relevant factors. Patients will receive camrelizumab as maintenance therapy every 3 weeks for up to 12 months (a total of 17 cycles), or until disease progression, unacceptable toxicity, investigator decision, or withdrawal of consent by the patient.

Primary Outcome Measure

1-year Progression- Free Survival [ Time Frame: from study enrollment to tumor progression (in any aspect) or death from any cause within 1 year. ]

Central Contacts