NCT03605706

A Trial of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With FOLFOX4 in Subjects With Advanced HCC Who Have Never Received Prior Systemic Treatment.

A Phase III, Multicentered, Randomized, Double-blinded, Parallel Controlled Study to Evaluate Camrelizumab (PD-1 Antibody) in Combination With FOLFOX4 Regimen Versus Placebo in Combination With FOLFOX4 Regime in First-Line Therapy in Subjects With Advanced Hepatocellular Carcinoma (HCC).

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 396 (estimated)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is being conducted to evaluate the efficacy and safety of SHR-1210 plus FOLFOX4 in subjects with advanced HCC who have never received prior systemic treatment compared to placebo plus FOLFOX4. The primary study hyposis is that Camrelizumab combined with FOLFOX4 treatment can improve Overall Survival when compared with placebo in combination with FOLFOX4 Regimen.

Conditions

• Advanced Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	SHR-1210	Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks
DRUG	FOLFOX4	Subjects receive FOLFOX4 treatment on D1-D2 of every 2 weeks
DRUG	Placebo	Subjects receive placebo of SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks

Timeline

• Start date: 2019-05-31
• Primary completion: 2023-02-01
• Completion: 2023-12-01
• First posted: 2018-07-30
• Last updated: 2022-02-10

Locations

1 site across 1 country: China