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

Unresectable Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06360042
• Other study ID #: MA-HCC-II-021
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2024
• Est. completion date: March 31, 2028

Study information

• Verified date: November 2023
• Source: Peking University Cancer Hospital & Institute
• Contact: Jun Zhou
• Phone: 13366152815
• Email: Joelbmu[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 111
• Est. completion date: March 31, 2028
• Est. primary completion date: March 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Unresectable Hepatocellular Carcinoma

Intervention

Drug:
• Adebrelimab plus Apatinib
Adebrelimab 1200mg intravenously every 3 weeks plus Apatinib 250mg orally once daily
• Adebrelimab plus Bevacizumab
Adebrelimab 1200mg intravenously plus Bevacizumab 15 mg/kg intravenously every 3 weeks
• Camrelizumab plus Apatinib
camrelizumab 200mg intravenously every 2 weeks plus Apatinib 250mg orally once daily

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Cancer Hospital & Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	12-month overall survival rate		Up to approximately 3 years
Secondary	ORR	Assessed by the investigator per RECIST v1.1 criteria	Up to approximately 3 years
Secondary	DCR	Assessed by the investigator per RECIST v1.1 criteria	Up to approximately 3 years
Secondary	DoR	Assessed by the investigator per RECIST v1.1 criteria	Up to approximately 3 years
Secondary	TTR	Assessed by the investigator per RECIST v1.1 criteria	Up to approximately 3 years
Secondary	TTP	Assessed by the investigator per RECIST v1.1 criteria	Up to approximately 3 years
Secondary	PFS	Assessed by the investigator per RECIST v1.1 criteria	Up to approximately 3 years
Secondary	OS		Up to approximately 3 years
Secondary	safety according to NCI Common Terminology Criteria for Adverse Events, version 5.0.		Up to approximately 3 years