Advanced Hepatocellular Carcinoma
Conditions
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.
Interventions
DRUGAdebrelimab
intravenous infusion
DRUGBevacizumab
intravenous infusion
DRUGSHR-8068
intravenous infusion
Sponsors
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose Limiting Toxicity | The observation period is 21 days after the first dose | — |
| Incidence and severity of grade ≥3 drug-related adverse events and serious adverse events of the two-drug or three-drug combination | 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 | — |
| Objective Response Rate | At the time point of every 6 or 9 weeks, up to 2 years | determined using RECIST v1.1 criteria, defined as best overall response (complete or partial response) across all assessment time points |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate, determined using RECIST v1.1 criteria | At the time point of every 6 or 9 weeks, up to 2 years |
| Progression-Free-Survival assessed by investigator | up to 2 years] |
Countries
China
Contacts
Primary ContactXin Shi
Backup ContactYing Sun
Outcome results
None listed