Anti-PD-1/PD-L1 Combined With Anti-angiogenic Agents as First-line Treatment for Unresectable HCC

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

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.

Study Overview

• Status: Recruiting
• Conditions: Unresectable Hepatocellular Carcinoma
• Intervention / Treatment: Drug: Adebrelimab plus Apatinib; Drug: Adebrelimab plus Bevacizumab; Drug: Camrelizumab plus Apatinib

• Study Type: Interventional
• Enrollment (Estimated): 111
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jun Zhou; Phone Number: 13366152815; Email: Joelbmu@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Beijing Cancer Hospital
      • Contact: Jun Zhou; Phone Number: 13366152815; Email: Joelbmu@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Adebrelimab（1200mg iv q3w） plus Apatinib(250mg po qd)	Drug: Adebrelimab plus Apatinib; Adebrelimab 1200mg intravenously every 3 weeks plus Apatinib 250mg orally once daily
Experimental: 2; Adebrelimab（1200mg iv q3w）plus Bevacizumab(15mg/kg iv q3w)	Drug: Adebrelimab plus Bevacizumab; Adebrelimab 1200mg intravenously plus Bevacizumab 15 mg/kg intravenously every 3 weeks
Experimental: 3; Camrelizumab (200mg iv q2w) plus Apatinib(250mg po qd)	Drug: Camrelizumab plus Apatinib; camrelizumab 200mg intravenously every 2 weeks plus Apatinib 250mg orally once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
12-month overall survival rate	Up to approximately 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS		Up to approximately 3 years
ORR	Assessed by the investigator per RECIST v1.1 criteria	Up to approximately 3 years
DCR	Assessed by the investigator per RECIST v1.1 criteria	Up to approximately 3 years
DoR	Assessed by the investigator per RECIST v1.1 criteria	Up to approximately 3 years
TTR	Assessed by the investigator per RECIST v1.1 criteria	Up to approximately 3 years
TTP	Assessed by the investigator per RECIST v1.1 criteria	Up to approximately 3 years
PFS	Assessed by the investigator per RECIST v1.1 criteria	Up to approximately 3 years
safety according to NCI Common Terminology Criteria for Adverse Events, version 5.0.		Up to approximately 3 years

Collaborators and Investigators

• Sponsor: Peking University Cancer Hospital & Institute
• Investigators: Principal Investigator: Jun Zhou, Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: February 27, 2024
• First Submitted That Met QC Criteria: April 8, 2024
• First Posted (Actual): April 11, 2024

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Protein Kinase Inhibitors; Bevacizumab; Apatinib
• Other Study ID Numbers: MA-HCC-II-021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No