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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06360042

Enrollment

111

Registered

2024-04-11

Start date

2024-01-01

Completion date

2028-03-31

Last updated

2024-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unresectable Hepatocellular Carcinoma

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.

Interventions

DRUGAdebrelimab plus Apatinib

Adebrelimab 1200mg intravenously every 3 weeks plus Apatinib 250mg orally once daily

DRUGAdebrelimab plus Bevacizumab

Adebrelimab 1200mg intravenously plus Bevacizumab 15 mg/kg intravenously every 3 weeks

DRUGCamrelizumab plus Apatinib

camrelizumab 200mg intravenously every 2 weeks plus Apatinib 250mg orally once daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
DCR	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
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
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	—
TTP	Up to approximately 3 years	Assessed by the investigator per RECIST v1.1 criteria

Countries

China

Contacts

Primary ContactJun Zhou

Joelbmu@126.com13366152815

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026