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

• Status: Not yet recruiting
• Trial end date: 2026-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
• Treatments: Bevacizumab

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.