NCT03802591

A Study of CS1001 in Subjects With Gastric Adenocarcinoma or Gastro-Esophageal Junction Adenocarcinoma

A Multi-Center, Double-Blind, Randomized, Phase III Study of CS1001 in Combination With CAPOX Chemotherapy Compared to Placebo in Combination With CAPOX Chemotherapy in Subjects With Unresectable Locally Advanced or Metastatic GC or GEJ Adenocarcinoma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 479 (actual)
• Sponsor: CStone Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase III, multi-Center, randomized, placebo-controlled trial to investigate the efficacy and safety of CS1001 in combination with Oxaliplatin and Capecitabine (CAPOX) chemotherapy in first-line subjects with unresectable locally advanced or metastatic gastric adenocarcinoma (GC) or gastro-esophageal junction (GEJ) adenocarcinoma.

Conditions

• Gastric Adenocarcinoma
• Gastroesophageal Junction Adenocarcinoma

Interventions

Type	Name	Description
DRUG	CS1001 monoclonal antibody	Participant will receive CS1001 monoclonal antibody by intravenous infusion every 3 weeks(Q3W), for up to 24 months
DRUG	CS1001 placebo	Participant will receive CS1001 placebo antibody by intravenous infusion every 3 weeks(Q3W), for up to 24 months
DRUG	Oxaliplatin	Administered as an IV infusion on Day 1 Q3W
DRUG	Capecitabine	Administered by oral, twice a day on Day 1 - Day 14 of each cycle.

Timeline

• Start date: 2019-03-28
• Primary completion: 2023-07-09
• Completion: 2023-09-22
• First posted: 2019-01-14
• Last updated: 2023-11-29

Locations

1 site across 1 country: China