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

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSun Yat-sen University

About this trial

•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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Radiation
  • First line therapy
  • First line therapy
  • operation

Treatment groups

398 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Sun Yat-sen University

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University

Sponsor institution