Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Bevacizumab

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Serplulimab (HLX10) in Combination With Bevacizumab and chemotherapy (XELOX)

placebo in combination with Bevacizumab and chemotherapy (XELOX)

a single fixed dose of 300 mg, intravenous infusion (IV), every 3 weeks (Day 1 of each cycle \[D1\]), non-reducible.

HLX10

7.5mg/kg, IV, every 3 weeks (D1 of each cycle), non-reducible.

HLX04、

This is a two-arm, randomized, double-blinded, multicenter phase III clinical study to evaluate the clinical efficacy of Serplulimab (HLX10) in Combination With Bevacizumab (HLX04) and Chemotherapy (XELOX) Versus Placebo in Combination With Bevacizumab (HLX04) and Chemotherapy (XELOX) in First-line Treatment of Patients With Metastatic Colorectal Cancer (mCRC)

Patients with confirmed unresectable metastatic/recurrent colorectal adenocarcinoma who have not received systemic anti-neoplastic therapy for metastatic/recurrent lesions will be included in this study.Approximately 6-12 patients will be enrolled in the Part I (Safety Run-in Period).Approximately 100 patients will be enrolled in the Part II (Phase II study, 50 in the test group and 50 in the control group).Approximately 654 patients will be enrolled in the Part III (Phase III study, 327 in the test group and 327 in the control group).

Part II (Phase II study): Approximately 40 study sites in China will participate.

Part III (Phase III study): A total of approximately 75 study sites in 7 countries(including China, the United States, Brazil, Indonesia, Russia, Poland, Spain, etc.) will participate.

The study consists of a screening period (up to 28 days), a treatment period (3-week cycle, up to 2 years), and a follow-up period (including a safety follow-up period, and a survival follow-up every 12 weeks).

A Clinical Study to Evaluate Efficacy and Safety of Serplulimab（HLX10） Combined With Bevacizumab（HLX04) and Chemotherapy (XELOX) in Patients With Metastatic Colorectal Cancer (mCRC)

A Randomized, Double-blind, Multicenter, PhaseⅡ/Ⅲ Clinical Study of Serplulimab (HLX10) in Combination With Bevacizumab (HLX04) and Chemotherapy (XELOX) Versus Placebo in Combination With Bevacizumab (HLX04) and Chemotherapy (XELOX) in First-line Treatment of Patients With Metastatic Colorectal Cancer (mCRC)

Progression-free survival (assessed by independent radiological review committee (IRRC) based on RECIST v1.1)

Progression-free survival (assessed by independent radiological review committee (IRRC) based on iRECIST，by the investigators based on RECIST v1.1))

Objective response rate (assessed by independent radiological review and the investigators based on RECIST v1.1))

Spots Global Cancer Trial Database for hlx04、

Every month we try and update this database with for hlx04、 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for hlx04、

Every month we try and update this database with for hlx04、 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for hlx04、 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.