A Study of HX008 Compared to Chemotherapy in the First-Line Treatment of Subjects With MSI-H/dMMR Metastatic Colorectal Cancer

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

190

Participants

Timeline

Start Date

December 20, 2022

Primary Completion Date

January 19, 2026

Study Completion Date

October 20, 2028

Conditions
Metastatic Colorectal Cancer
Interventions
DRUG

HX008

Drug: HX008 200 mg ,Q3W

DRUG

Investigator's Choice Chemotherapy

"Drug: bevacizumab 5mg/kg given by IV every 14 days. Other Name: Avastin~Drug: cetuximab 400 mg/sqm initial dose, then 250 mg/sqm once weekly thereafter. Other Name: Erbitux~Drug: oxaliplatin 8 5 mg/sqm by IV, day1. Component of mFOLFOX6.~Drug: irinotecan 180 mg/sqm by IV, day1.Component of FOLFORI.~Drug: calcium Folinate 400 mg/sqm by IV, day1.Component of mFOLFOX6 or FOLFORI.~Drug: 5-fluorouracil 400 mg/sqm, day1,followed by 2400 mg/sqm iv infusion over 46\~48 h.Component of mFOLFOX6 or FOLFORI."

Trial Locations (10)

110010

The First Hospital of China Medical University, Shenyang

150081

Harbin Medical University Cancer Hospital, Harbin

Unknown

Anhui Provincial Cancer Hospital, Hefei

Cancer Hospital Chinese Academy of Medical Sciences, Beijing

Guangxi Medical University Cancer Hospital, Nanning

Henan Cancer Hospital, Zhengzhou

Hubei Cancer Hospital, Wuhan

Hunan Cancer Hospital, Changsha

Tianjin People's Hospital, Tianjin

The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an

All Listed Sponsors
lead

Taizhou Hanzhong biomedical co. LTD

INDUSTRY