Biomarker Based Neoadjuvant Strategies for Locally Advanced Resectable ESCC

Sponsor
Fujian Medical University Union Hospital
Study ID
NCT06601309
Phase
PHASE2
Status
Recruiting
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Conditions

  • Esophageal Squamous Cell Carcinoma

Eligibility Criteria

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

Interventions

  • Serplulimab — DRUG
    Serplulimab (300 mg) administered intravenously on day 1 of each 21-day cycle for 2 cycles.
  • Paclitaxel+Cisplatin (Neoadjuvant Chemotherapy) — DRUG
    Paclitaxel (175 mg/m²) and Cisplatin (75 mg/m²) administered intravenously on day 1 of each 21-day cycle for 2 cycles as part of neoadjuvant chemotherapy.
  • Paclitaxel+Cisplatin(Concurrent Chemoradiotherapy) — DRUG
    Paclitaxel (50 mg/m²) and Cisplatin (25 mg/m²) administered intravenously on days 1, 8, 15, and 22 of a 4-week cycle as part of concurrent chemoradiotherapy.
  • Radiotherapy — RADIATION
    Radiotherapy at a dose of 40 Gy, delivered in 20 fractions over 4 weeks.

Study Details

This study aims to evaluate the impact of the neoadjuvant treatment strategy based on CPS score on the pathological complete response (pCR) rate in patients with resectable locally advanced esophageal cancer.

Key Dates

Start date
Jul 11, 2024
Status verified
Sep 2025
Primary completion
Jul 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
90 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: High PD-L1 Expression Group (CPS ≥ 20)
    Patients with high PD-L1 expression (CPS ≥ 20) will receive neoadjuvant immunotherapy alone. This treatment consists of serplulimab for 2 cycles.
  • Experimental: Moderate PD-L1 Expression Group (CPS 10-20)
    Patients with moderate PD-L1 expression (CPS 10-20) will receive neoadjuvant chemotherapy combined with immunotherapy. This includes paclitaxel and cisplatin along with serplulimab for 2 cycles.
  • Experimental: Low PD-L1 Expression Group (CPS < 10)
    Patients with low PD-L1 expression (CPS \< 10) will receive standard neoadjuvant chemoradiotherapy. This includes paclitaxel and cisplatin along with radiotherapy (40 Gy in 20 fractions over 4 weeks).

Primary Outcome Measure

Pathological Complete Response (pCR) Rate [ Time Frame: after the pathological examination of surgical speciments within 14 days after the operation ]

Central Contacts

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