A Clinical Study of SHR-8068 Combined With Adebrelimab and Bevacizumab Versus Sintilimab Combined With Bevacizumab for the Treatment of Advanced Hepatocellular Carcinoma (KYLIN-02)

Suzhou Suncadia Biopharmaceuticals

Status and phase: Enrolling; Phase 3

Conditions: Advanced Hepatocellular Carcinoma

Treatments: Drug: Adebrelimab; Drug: Sintilimab; Drug: Bevacizumab; Drug: SHR-8068

Study type: Interventional

Funder types: Industry

Identifiers

NCT06618664

SHR-8068-301

Details and patient eligibility

About

This study aims to evaluate the efficacy of SHR-8068 combined with Adebrelimab and Bevacizumab compared with Sintilimab combined with Bevacizumab for the first-line treatment of advanced HCC (KYLIN-02).

Enrollment: 590 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Able and willing to provide a written informed consent.
2. ≥ 18 years old, both male and female.
3. Unresectable locally advanced or metastatic HCC confirmed by histopathologically/cytologically.
4. At least one measurable lesion based on RECIST v1.1 criteria.
5. Barcelona clinic liver cancer: Stage B or C.
6. No previous systemic antitumor therapy for HCC.
7. ECOG PS of 0-1.
8. Child-Pugh score of A or B7.
9. Expected survival period ≥ 12 weeks.
10. Adequate organ function.
11. Blood pregnancy negative (women of childbearing age) and non-breastfeeding, effective contraception.

Exclusion criteria

1. Hepatic cholangiocarcinoma, mixed hepatocellular carcinoma -cholangiocarcinoma, sarcomatoid hepatocellular carcinoma and fibrolamellar hepatocellular carcinoma.
2. Patients with other malignancies currently or within the past 5 years.
3. With known severe allergic reactions to any other monoclonal antibodies.
4. Patients with known CNS metastasis or hepatic encephalopathy.
5. Patients with liver tumor burden greater than 50% of total liver in volume or received liver transplants.
6. Patients with symptomatic ascites or pleural effusion.
7. Patients with hypertension which cannot be well controlled by antihypertensives.
8. Uncontrolled cardiac diseases or symptoms.
9. Known hereditary or acquired bleeding (e.g., coagulopathy) or a tendency to clot (e.g., hemophiliacs).
10. Major vascular disease occurred in the 6 months before randomization.
11. Gastrointestinal perforation or gastrointestinal fistula within 6 months before randomization.
12. Major surgery within 28 days before randomization or expected to require major surgery during the study period.
13. Active infection, or fever of unknown cause ≥ 38.5℃ in the first 7 days of randomization, or WBC > 15×109/L at baseline.
14. Known positive history of human immunodeficiency virus test or acquired immunodeficiency syndrome, known HBV infection, known HCV infection.
15. Patients who received live vaccines within 28 days before randomization, or are expected to be vaccinated during the treatment period
16. Patients with other potential factors that may affect the study results.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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590 participants in 2 patient groups

SHR-8068 combined with Adebrelimab and Bevacizumab

Experimental group

Treatment:

Drug: Bevacizumab

Drug: SHR-8068

Drug: Adebrelimab

Sintilimab combined with Bevacizumab

Active Comparator group

Treatment:

Drug: Bevacizumab

Drug: Sintilimab