Anti-PD-1/PD-L1 Combined With Anti-angiogenic Agents as First-line Therapy for Unresectable Hepatocellular Carcinoma: a Multicenter, Randomized, Open-label Trial

Peking University Cancer Hospital & Institute1 site in 1 country111 target enrollmentJanuary 1, 2024

ConditionsUnresectable Hepatocellular Carcinoma

InterventionsAdebrelimab plus Apatinib Adebrelimab plus Bevacizumab Camrelizumab plus Apatinib

Overview

Phase: Phase 2
Intervention: Adebrelimab plus Apatinib
Conditions: Unresectable Hepatocellular Carcinoma
Sponsor: Peking University Cancer Hospital & Institute
Enrollment: 111
Locations: 1
Primary Endpoint: 12-month overall survival rate
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a multicenter, randomized, open-label clinical study to evaluate the efficacy and safety of Adebrelimab plus Apatinib (cohort 1), or Adebrelimab plus Bevacizumab (cohort 2), or Camrelizumab plus Apatinib (cohort 3) as first-line treatment of unresectable HCC.

Registry

clinicaltrials.gov

Start Date

January 1, 2024

End Date

March 31, 2028

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Peking University Cancer Hospital & Institute

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC)
•No prior systemic therapy for HCC. Previous use of herbal therapies/traditional Chinese medicines with anti-cancer activity included in the label is allowed.
•BCLC stage B or C, and not suitable for surgical or local therapy, or has progressed following surgical and/or local therapy
•At least one measurable lesion per RECIST v1.1
•ECOG Performance Status of 0 or 1
•Child-Pugh class of A5 to B7
•Adequate organ function

Exclusion Criteria

•Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and lamellar cell carcinoma; other active malignant tumor except HCC within 5 years or simultaneously
•Moderate-to-severe ascites with clinical symptoms
•History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal hemorrhage
•Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment
•Known genetic or acquired hemorrhage or thrombotic tendency
•Thrombosis or thromboembolic event within 6 months prior to the start of study treatment
•Hypertension that can not be well controlled through antihypertensive drugs Factors to affect oral administration
•History of hepatic encephalopathy
•Previous or current presence of metastasis to central nervous system

Arms & Interventions

1

Adebrelimab（1200mg iv q3w） plus Apatinib(250mg po qd)

Intervention: Adebrelimab plus Apatinib

2

Adebrelimab（1200mg iv q3w）plus Bevacizumab(15mg/kg iv q3w)

Intervention: Adebrelimab plus Bevacizumab

3

Camrelizumab (200mg iv q2w) plus Apatinib(250mg po qd)

Intervention: Camrelizumab plus Apatinib

Outcomes

Primary Outcomes

12-month overall survival rate

Time Frame: Up to approximately 3 years

Secondary Outcomes

TTR(Up to approximately 3 years)
ORR(Up to approximately 3 years)
DCR(Up to approximately 3 years)
DoR(Up to approximately 3 years)
TTP(Up to approximately 3 years)
PFS(Up to approximately 3 years)
OS(Up to approximately 3 years)
safety according to NCI Common Terminology Criteria for Adverse Events, version 5.0.(Up to approximately 3 years)