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

Peking University Cancer Hospital & Institute

Status and phase: Enrolling; Phase 2

Conditions: Unresectable Hepatocellular Carcinoma

Treatments: Drug: Adebrelimab plus Bevacizumab; Drug: Adebrelimab plus Apatinib; Drug: Camrelizumab plus Apatinib

Study type: Interventional

Funder types: Other

Identifiers

NCT06360042

MA-HCC-II-021

Details and patient eligibility

About

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.

Enrollment: 111 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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111 participants in 3 patient groups

1

Experimental group

Description:

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

Treatment:

Drug: Adebrelimab plus Apatinib

2

Experimental group

Description:

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

Treatment:

Drug: Adebrelimab plus Bevacizumab

3

Experimental group

Description:

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

Treatment:

Drug: Camrelizumab plus Apatinib