Clinical trial NCT05444088: Study of SHR-8068 Combined With Adebrelimab and Bevacizumab in the Treatment of Advanced Hepatocellular Carcinoma
Official title: An Open-label, Multicenter Phase Ib/II Clinical Study of SHR-8068 Combined With Adebrelimab and Bevacizumab in the Treatment of Advanced Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced Hepatocellular Carcinoma
Lead sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-07-05
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a multicenter, open-label, dose-finding and efficacy-expansion phase Ib/II study. The phase Ib design is for dose finding and dose confirmation, using modified 3+3 design; the phase II design is for efficacy expansion through randomization.
Primary purpose: TREATMENT

Brief 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 criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma or mixed cholangiocarcinoma / hepatocellular carcinoma;
2. Patients with any active, known or suspected autoimmune disorder;
3. Systemic treatment with corticosteroids or other immunosuppressants within 1 month before the first dose;
4. With known severe allergic reactions to any other monoclonal antibodies;
5. Patients with known CNS metastasis or hepatic encephalopathy;
6. Patients with liver tumor burden greater than 50% of total liver in volume, or patients who have previously undergone liver transplantation;
7. 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;
8. Patients with other malignancies currently or within the past 5 years;
9. Patients with hypertension which cannot be well controlled by antihypertensives;
10. Uncontrolled cardiac diseases or symptoms;
11. Patients with other potential factors that may affect the study results.

Primary outcomes:
measure: Dose Limiting Toxicity
timeFrame: The observation period is 21 days after the first dose
measure: Incidence and severity of grade ≥3 drug-related adverse events and serious adverse events of the two-drug or three-drug combination
timeFrame: The observation period is from the time when all informed subjects signed the informed consent to the end of the safety follow-up period, up to 2 years
measure: Objective Response Rate
timeFrame: At the time point of every 6 or 9 weeks, up to 2 years
Secondary outcomes:
measure: Disease Control Rate, determined using RECIST v1.1 criteria
timeFrame: At the time point of every 6 or 9 weeks, up to 2 years
measure: Progression-Free-Survival assessed by investigator
timeFrame: up to 2 years]
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Hospital Ethics Commitee
state: Anhui
Study officials:
References: