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

RecruitingPhase 2Ages 18 Years - 75 YearsAllSecond Affiliated Hospital of Zunyi Medical Unive…
NCT07559045 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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),

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📋 Eligibility rules (as published)
Inclusion Criteria: * Histologically or cytologically confirmed unresectable stage III-IVA esophageal squamous cell carcinoma (ESCC) * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Adequate organ function (bone marrow, liver, renal, cardiac) within 2 weeks prior to randomization * Measurable or evaluable disease per RECIST 1.1 * Willing to provide written informed consent Exclusion Criteria: * Previous radiotherapy to the chest or previous systemic chemotherapy for ESCC * History of other malignancies within the last 5 years (except cured basal cell carcinoma or cervical carcinoma in situ) * Severe comorbidities (uncontrolled hypertension, NYHA class III-IV heart failure, active infection, etc.) * Known hypersensitivity to any study drugs (paclitaxel, cisplatin/carboplatin, PD-1 antibody) * Pregnant or lactating women * Participation in another clinical trial within 30 days prior to randomization
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What it tests

  • Paclitaxel plus Cisplatin or Carboplatin (Induction Chemotherapy)
  • Weekly Paclitaxel plus Cisplatin or Carboplatin (Concurrent Chemotherapy)
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Where

1 site
The Second Affiliated Hospital of Zunyi Medical University, Xinpu New District, Honghuagang District, Zunyi City, Guizhou Province
Zunyi, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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