SBRT Combined with Camrelizumab and Apatinib for Conversion Therapy in Patients with Unresectable Hepatocellular Carcinoma.

Sun Yat-sen University

Status and phase

Not yet enrolling

Phase 3

Phase 2

Conditions

Unresectable Hepatocellular Carcinoma (HCC)

Treatments

Radiation: Radiation

Procedure: operation

Drug: First line therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT06739317

MA-HCC-II/III-030

Details and patient eligibility

About

•This is a randomized, open-label, multi-center, phases 2 and phase 3 trial to evaluate the efficacy and safety of SBRT combined with Camrelizumab and Apatinib as conversion therapy versus Camrelizumab combined with Apatinib as first-Line therapy for unresectable hepatocellular carcinoma.

Enrollment

398 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Signed Informed Consent Form (ICF).
Aged 18 years or older.
Hepatocellular carcinoma confirmed by histology/cytology. Cirrhosis meets the clinical diagnostic criteria for hepatocellular carcinoma of the American Association for the Diagnosis of Liver Diseases (AASLD).
Barcelona Clinic Liver Cancer stage B or C disease, which was not amenable to radical surgery.
ECOG Performance Status of 0 or 1.
Child-Pugh class of A.

Exclusion criteria

Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and lamellar cell carcinoma; other active malignant tumor except HCC within 5 years or simultaneously.
Existence of active autoimmune disease or history of autoimmune disease and may relapse.
Patients with innate or acquired immune deficiency (e.g., HIV infection).
Known allergies to study drugs or excipients.