SYS6010 Versus Chemotherapy in Locally Advanced or Metastatic/Recurrent Esophageal Squamous Cell Carcinoma

Sponsor
CSPC Megalith Biopharmaceutical Co.,Ltd.
Study ID
NCT07417735
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Locally Advanced/Metastatic/Recurrent ESCC

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SYS6010 — DRUG
    SYS6010 IV
  • Investigator's Choice of Chemotherapy (Irinotecan hydrochloride，Paclitaxel，Docetaxel) — DRUG
    Investigator's choice of chemotherapy means the chemotherapy chosen by investigators/doctors to treat Locally Advanced/Metastatic/Recurrent ESCC, including Irinotecan hydrochloride（125 mg/m\^2 by IV on D1 and D8，3 weeks/cycle；or 150 \~180 mg/m\^2 by IV on D1，Q2W，4 weeks/cycle）， Paclitaxel（175 mg/m\^2 by IV on D1，3 weeks/cycle；or 80 mg/m\^2 by IV on D1/D8/D15/D22，4 weeks/cycle；or 80 mg/m\^2 by IV on D1/D8/D15，4 weeks/cycle）, or Docetaxel（75\~100 mg/m\^2 by IV on D1，3 weeks/cycle）

Study Details

This study is a randomized, Controlled, Open-Label, Multicenter Phase Ⅲ Study of SYS6010 vs Investigator's Choice Single-Agent Chemotherapy in Locally Advanced/Metastatic/Recurrent ESCC Patients with Failure of At Least One Line of Systemic Therapy

Key Dates

Start date
Mar 18, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

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

Arms

  • Experimental: SYS6010
    SYS6010 monotherapy
  • Active Comparator: Chemotherapy
    Investigator's choice of one chemotherapy treatment (Irinotecan hydrochloride，Paclitaxel，Docetaxel

Primary Outcome Measure

Progression Free Survival (PFS) Assessed by Blinded Independent Central Review(BICR) According to the RECIST 1.1 Criteria [ Time Frame: Up to 2 years ]

Central Contacts