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

NCT07417735 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 436

Last updated 2026-02-18

No results posted yet for this study

Summary

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

Conditions

  • Locally Advanced/Metastatic/Recurrent ESCC

Interventions

DRUG

SYS6010

SYS6010 IV

DRUG

Investigator's Choice of Chemotherapy (Irinotecan hydrochloride，Paclitaxel，Docetaxel)

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）

Sponsors & Collaborators

  • CSPC Megalith Biopharmaceutical Co.,Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-18
Primary Completion
2028-12-31
Completion
2029-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07417735 on ClinicalTrials.gov