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

Phase 2

Recruiting

• Conditions: Unresectable Hepatocellular Carcinoma
• Interventions: Drug: Adebrelimab plus Apatinib; Drug: Adebrelimab plus Bevacizumab; Drug: Camrelizumab plus Apatinib

• Registration Number: NCT06360042
• Lead Sponsor: Peking University Cancer Hospital & Institute

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-11
• Study Start: 2024-01-01
• Study First Submitted: 2024-02-27
• Study First Submitted QC: 2024-04-08
• Study First Posted: 2024-04-11
• Last Update Submitted: 2024-04-19
• Last Update Posted: 2024-04-22
• Primary Completion: 2027-03-31
• Study Completion: 2028-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 111

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Adebrelimab plus Apatinib	Adebrelimab（1200mg iv q3w） plus Apatinib(250mg po qd)
2	Adebrelimab plus Bevacizumab	Adebrelimab（1200mg iv q3w）plus Bevacizumab(15mg/kg iv q3w)
3	Camrelizumab plus Apatinib	Camrelizumab (200mg iv q2w) plus Apatinib(250mg po qd)

Primary Outcome Measures

Name	Time	Method
12-month overall survival rate	Up to approximately 3 years

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China