Immunotherapy Plus Chemotherapy vs. Chemoradiotherapy for Thoracic Squamous Esophageal Carcinoma

Sponsor
Fujian Medical University Union Hospital
Study ID
NCT05821452
Phase
PHASE2
Status
Unknown

Conditions

  • Chemotherapy
  • Radiation Therapy

Eligibility Criteria

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

Interventions

  • Camrelizumab — DRUG
    200mgQ3w
  • Paclitaxel — DRUG
    175mg/m2，D1，Q3w
  • Cisplatin — DRUG
    75mg/m2，D1，Q3w
  • Radiotherapy — RADIATION
    41.4Gy, 1.8Gy each time, 5 times a week

Study Details

The investigators conducted a phase II, prospective, two-arm clinical study to explore the efficacy of Camrelizumab combined with chemotherapy versus chemoradiotherapy for conversion therapy of potentially resectable advanced esophageal squamous cell carcinoma. This study will provide more evidence for conversion treatment of initially unresectable locally advanced esophageal squamous cell carcinoma and contribute to the development of treatment guidelines for esophageal cancer.

Key Dates

Start date
May 25, 2023
Status verified
Apr 2023
Primary completion
May 25, 2024
Completion
May 30, 2026

Study Design

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

Arms

  • Experimental: Immumotherapy plus Chemotherapy
    Paclitaxel: 175mg/m2, intravenous infusion on the first day of each cycle, every 3 weeks for a cycle (Q3W), a total of 3 cycles. Cisplatin: 75mg/m2, intravenous infusion on the first day of each cycle, every 3 weeks for a cycle (Q3W), a total of 3 cycles. Camrelizumab: 200mg was administered intravenously on the first day of each cycle, every 3 weeks as a cycle (Q3W), for a total of 3 cycles.
  • Experimental: chemoradiotherapy
    Paclitaxel: 175mg/m2, intravenous infusion on the first day of each cycle, every 3 weeks for a cycle (Q3W), a total of two cycles Cisplatin: 75mg/m2, intravenous infusion on the first day of each cycle, every 3 weeks for a cycle (Q3W), a total of two cycles Radiotherapy: Irradiation mode and dose: three-dimensional conformal or intensity modulated radiotherapy technology was adopted, 41.4Gy, 1.8Gy each time, 5 times a week.

Primary Outcome Measure

R0 removal rate [ Time Frame: up to 3 months ]

Central Contacts

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