NCT07417735

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

A Randomized, Controlled, Open-Label, Multicenter Phase Ⅲ Clinical Study to Evaluate the Efficacy and Safety of SYS6010 Versus Investigator's Choice Chemotherapy in Patients With Locally Advanced or Metastatic/Recurrent Esophageal Squamous Cell Carcinoma Who Have Failed at Least One Line of Systemic Therapy.

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 436 (estimated)
• Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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）

Timeline

• Start date: 2026-03-18
• Primary completion: 2028-12-31
• Completion: 2029-12-31
• First posted: 2026-02-18
• Last updated: 2026-02-18