A Study to Compare the Efficacy and Safety of LY01015 and Opdivo® Combined Respectively With Chemotherapy in Advanced or Metastatic Esophageal Squamous Cell Carcinoma

Sponsor
Shandong Boan Biotechnology Co., Ltd
Study ID
NCT06022861
Phase
PHASE3
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

  • LY01015 — DRUG
    Intravenouslly (IV) 240mg every 2 weeks (Q2W) during the combined chemotherapy period, thereafter, 480mg every 4 weeks(Q4W) during the maintenance treatment period
  • Fluorouracil — DRUG
    Intravenouslly (IV) l 800mg/m2 every 4 weeks (（on Day 1 through Day 5)during the combined chemotherapy period
  • Cisplatin — DRUG
    Intravenouslly (IV) 80mg/m2 every 4 weeks (Q4W) during the combined chemotherapy period
  • Opdivo® — DRUG
    Intravenouslly (IV) 240mg every 2 weeks (Q2W) during the combined chemotherapy period, 480mg every 4 weeks(Q4W) during the maintenance treatment period within 24 weeks, thereafter converted to LY01015 480mg every 4 weeks(Q4W).

Study Details

This is a randomized, double-blind, multicenter, Phase 3 study to compare the efficacy and safety of LY01015 and Opdivo®（Nivolumab Injection）combined respectively with fluorouracil plus cisplatin in participants with unresectable advanced, recurrent or metastatic previously untreated esophageal squamous cell carcinoma.

Key Dates

Start date
Oct 12, 2023
Status verified
Sep 2024
Primary completion
Jun 30, 2025
Completion
Dec 31, 2026

Study Design

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

Arms

  • Experimental: LY01015+ Fluorouracil + Cisplatin
  • Active Comparator: Opdivo® + Fluorouracil + Cisplatin

Primary Outcome Measure

Objective Response Rate(ORR) as assessed by IRC [ Time Frame: from baseline to week 16 ]

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