Trial intelligence / Profile preview

Camrelizumab plus FOLFOX4 in advanced HCC

NCT03605706Phase 3

Key facts

Status
Unknown
Start
May 2019
Primary completion
Feb 2023
Countries
1
Sponsor
Hengrui
Modality
Immune Checkpoint Inhibitors
Conditions
hepatocellular carcinoma (HCC)
01

Overview

Phase 3, randomised, double-blind trial in hepatocellular carcinoma (HCC) comparing Camrelizumab + FOLFOX4 with Placebo + FOLFOX4 (2 arms). Primary endpoint: Overall Survival at 3 years. Status: unknown.

02

Design

2 arms
Study design
RandomizedDouble-blind
  • Camrelizumab + FOLFOX4

    Camrelizumab (SHR-1210) 3mg/kg IV D1 + FOLFOX4 (Oxaliplatin, Leucovorin, Fluorouracil) q2w

  • Placebo + FOLFOX4

    Placebo IV D1 + FOLFOX4 (Oxaliplatin, Leucovorin, Fluorouracil) q2w

03

Who it enrols

Patients with advanced/metastatic HCC, no prior systemic treatment, Child-Pugh A or B7, and ECOG 0-1.

04

Endpoints

Primary

  • Overall Survival

Secondary

  • Objective Response Rate

  • Time to Progression

  • Duration of Response

  • Disease Control Rate

  • Progression-Free Survival

  • Adverse Events

  • Overall Survival Rate

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