Study of SHR-8068 Combined With Adebrelimab and Bevacizumab in the Treatment of Advanced Hepatocellular Carcinoma
Phase 1
Recruiting
- Conditions
- Advanced Hepatocellular Carcinoma
- Interventions
- Registration Number
- NCT05444088
- Lead Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 129
Inclusion Criteria
- 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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Adebrelimab in combination with Bevacizumab and SHR-8068 RP2D2 SHR-8068 - Adebrelimab in combination with Bevacizumab and SHR-8068 RP2D1 SHR-8068 - Adebrelimab in combination with Bevacizumab Bevacizumab - Adebrelimab in combination with Bevacizumab Adebrelimab - Adebrelimab in combination with Bevacizumab and SHR-8068 RP2D1 Bevacizumab - Adebrelimab in combination with Bevacizumab and SHR-8068 RP2D1 Adebrelimab - Adebrelimab in combination with Bevacizumab and SHR-8068 RP2D2 Adebrelimab - Adebrelimab in combination with Bevacizumab and SHR-8068 RP2D2 Bevacizumab -
- Primary Outcome Measures
Name Time Method Dose Limiting Toxicity The observation period is 21 days after the first dose 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
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
- Secondary Outcome Measures
Name Time Method 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]
Trial Locations
- Locations (1)
Anhui Provincial Hospital Ethics Commitee
🇨🇳Hefei, Anhui, China