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the Efficacy and Safety of Rulonilimab in Combination With Lenvatinib in Hepatocellular Carcinoma

NCT05408221 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 576

Last updated 2023-03-10

No results posted yet for this study

Summary

There are two studies included in this protocol. One is an open-label Phase Ⅱ study . The other is a multi-center, double-blind, randomized, phase III study .

Conditions

Interventions

DRUG

Rulonilimab+Lenvatinib

Rulonilimab, intravenous (i.v.) administration every 3 weeks; Lenvatinib oral administration, once daily

DRUG

Rulonilimab placebo +Lenvatinib

Rulonilimab placebo, intravenous (i.v.) administration every 3 weeks; Lenvatinib oral administration, once daily

Sponsors & Collaborators

  • Shandong New Time Pharmaceutical Co., LTD

    lead INDUSTRY

Principal Investigators

  • Cai Jian qiang · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  • Zhou Ai ping, professor · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-11
Primary Completion
2025-08-01
Completion
2026-08-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05408221 on ClinicalTrials.gov