NCT06022861View on ClinicalTrials.gov

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

PHASE3RecruitingINTERVENTIONAL
Enrollment

510

Participants

Timeline

Start Date

October 12, 2023

Primary Completion Date

June 30, 2025

Study Completion Date

December 31, 2026

Conditions
Esophageal Squamous Cell Carcinoma
Interventions
DRUG

LY01015

Intravenouslly (IV) 240mg every 2 weeks (Q2W) during the combined chemotherapy period, thereafter, 480mg every 4 weeks(Q4W) during the maintenance treatment period

DRUG

Fluorouracil

Intravenouslly (IV) l 800mg/m2 every 4 weeks (（on Day 1 through Day 5)during the combined chemotherapy period

DRUG

Cisplatin

Intravenouslly (IV) 80mg/m2 every 4 weeks (Q4W) during the combined chemotherapy period

DRUG

Opdivo®

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).

Trial Locations (1)

Unknown

RECRUITING

Sun Yat-sen University Cancer Center, Guangzhou

All Listed Sponsors
lead

Shandong Boan Biotechnology Co., Ltd

INDUSTRY