RecruitingPhase 1Phase 2NCT05444088

Study of SHR-8068 Combined With Adebrelimab and Bevacizumab in the Treatment of Advanced Hepatocellular Carcinoma

An Open-label, Multicenter Phase Ib/II Clinical Study of SHR-8068 Combined With Adebrelimab and Bevacizumab in the Treatment of Advanced Hepatocellular Carcinoma

Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Enrollment

129 participants

Start Date

Aug 2, 2022

Study Type

INTERVENTIONAL

Conditions

Advanced Hepatocellular Carcinoma

Summary

To evaluate the tolerability and safety of SHR-8068 in combination with Adebrelimab and Bevacizumab in subjects with advanced HCC; To evaluate the efficacy of SHR-8068 in combination with Adebrelimab and Bevacizumab in subjects with advanced HCC.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria9

Age 18\~75 years old, both male and female;
Stage 1: pathologically diagnosed, incurable advanced HCC subjects who have failed standard treatment or were unwilling to accept standard treatment;
Stage 2: pathologically diagnosed, incurable advanced HCC subjects, who have no prior immunotherapy, no more than 1 line of previous system treatment;
At least one measurable lesion based on RECIST v1.1 criteria;
Barcelona clinic liver cancer: Stage B or C;
ECOG PS score: 0-1 points;
Child-Pugh score: ≤ 7;
Expected survival period ≥ 3 months;
Adequate organ function.

Exclusion Criteria11

Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma or mixed cholangiocarcinoma / hepatocellular carcinoma;
Patients with any active, known or suspected autoimmune disorder;
Systemic treatment with corticosteroids or other immunosuppressants within 1 month before the first dose;
With known severe allergic reactions to any other monoclonal antibodies;
Patients with known CNS metastasis or hepatic encephalopathy;
Patients with liver tumor burden greater than 50% of total liver in volume, or patients who have previously undergone liver transplantation;
Patients with symptomatic ascites or pleural effusion requiring paracentesis and drainage, or patients who have undergone ascites or pleural effusion drainage within 2 weeks before the first dose;
Patients with other malignancies currently or within the past 5 years;
Patients with hypertension which cannot be well controlled by antihypertensives;
Uncontrolled cardiac diseases or symptoms;
Patients with other potential factors that may affect the study results.