Induction Chemo-Immunotherapy + Radiotherapy vs Concurrent Chemoradiotherapy for Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma

Condition(s) studied

Investigational drug(s) / intervention(s)

Paclitaxel plus Cisplatin or Carboplatin (Induction Chemotherapy): Paclitaxel 150-175 mg/m² combined with cisplatin 75 mg/m² or carboplatin AUC 5 (maximum 600 mg), administered intravenously every 3 weeks for 3 cycles, concurrent with PD-1 antibody induction therapy for unresectable stage III-IVA esophageal squamous cell carcinoma.

Weekly Paclitaxel plus Cisplatin or Carboplatin (Concurrent Chemotherapy): Paclitaxel 50 mg/m² combined with cisplatin 25 mg/m² or carboplatin AUC 5 (maximum 600 mg), administered intravenously once weekly for 5 cycles, concurrent with thoracic radiotherapy (50.4Gy in 28 fractions) for unresectable stage III-IVA esophageal squamous cell carcinoma.

Study summary

This is a prospective, randomized, phase II clinical study in patients with unresectable stage III-IVA esophageal squamous cell carcinoma (ESCC). Eligible patients will be randomly assigned in a 1:1 ratio to two treatment groups. The experimental group will receive 3 cycles of induction therapy with PD-1 antibody plus chemotherapy, followed by radiotherapy, and then maintenance therapy with PD-1 antibody monotherapy. The control group will receive concurrent chemoradiotherapy, followed by maintenance therapy with PD-1 antibody monotherapy. The primary endpoints are the complete response (CR) rate at 3 months after radiotherapy (assessed by investigators) and the 1-year progression-free survival (PFS) rate. Secondary endpoints include overall survival (OS), progression-free survival (PFS), duration of response, objective response rate (ORR), local-regional recurrence-free survival (LRFS), distant metastasis-free survival (DMFS), quality of life, and safety profile.

Eligibility

Primary outcome measure(s)

• Complete Response (CR) Rate at 3 Months After Radiotherapy (Investigator-Assessed) — 3 months after completion of radiotherapy
  Proportion of patients achieving complete response (CR) per RECIST 1.1, assessed by investigators at 3 months after completion of radiotherapy
• 1-Year Progression-Free Survival (PFS) Rate — 1 year after randomization
  Proportion of patients alive and without disease progression at 1 year after randomization

Trial sites (1)

Other trials for the same condition