Clinical trial NCT06360042: Anti-PD-1/PD-L1 Combined With Anti-angiogenic Agents as First-line Treatment for Unresectable HCC
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Unresectable Hepatocellular Carcinoma
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 12-month overall survival rate
timeFrame: Up to approximately 3 years
Secondary outcomes:
measure: ORR
timeFrame: Up to approximately 3 years
measure: DCR
timeFrame: Up to approximately 3 years
measure: DoR
timeFrame: Up to approximately 3 years
measure: TTR
timeFrame: Up to approximately 3 years
measure: TTP
timeFrame: Up to approximately 3 years
measure: PFS
timeFrame: Up to approximately 3 years
measure: OS
timeFrame: Up to approximately 3 years
measure: safety according to NCI Common Terminology Criteria for Adverse Events, version 5.0.
timeFrame: Up to approximately 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Jun Zhou
role: PRINCIPAL_INVESTIGATOR
References: