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

Phase 2

Not yet recruiting

• Conditions: Unresectable Hepatocellular Carcinoma (HCC)
• Interventions: Drug: First line therapy; Radiation: Radiation; Procedure: operation

• Registration Number: NCT06739317
• Lead Sponsor: Sun Yat-sen University

Brief Summary

•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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-12-04
• Study First Submitted QC: 2024-12-12
• Last Update Submitted: 2024-12-12
• Study First Posted: 2024-12-18
• Last Update Posted: 2024-12-18
• Study Start: 2025-01-01
• Primary Completion: 2030-12-31
• Study Completion: 2031-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 398

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	First line therapy	-
Experimental group	Radiation	-
Experimental group	First line therapy	-
Experimental group	operation	-

Primary Outcome Measures

Name	Time	Method
Overall Survival	Up to approximately 3 years	The primary endpoint of phase 3 study is OS
The R0 Resection rate of the experimental group	Up to approximately 30 days	The primary endpoint of phase 2 study is the R0 Resection rate of the experimental group

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	Up to approximately 3 years	The ORR is assessed by the investigators according to RECIST v1.1 and mRECIST, respectively.
Disease control rate (DCR)	Up to approximately 3 years.	The DCR is assessed by the investigators according to RECIST v1.1 and mRECIST, respectively.
Time to Response (TTR)	Up to approximately 3 years.	The TTR is assessed by the investigators according to RECIST v1.1 and mRECIST, respectively.
Duration of response (DoR)	Up to approximately 3 years.	The DoR is assessed by the investigators according to RECIST v1.1 and mRECIST, respectively.
Time to progression (TTP)	Up to approximately 3 years.	The TTP is assessed by The investigators according to RECIST v1.1 and mRECIST,
Event free survival (EFS)	Up to approximately 3 years.	The EFS is assessed by the investigators according to RECIST v1.1 and mRECIST, respectively.
Conversion rate	Up to approximately 30 days.	The conversion rate of the experimental group.
Resection rate	Up to approximately 30 days.	The resection rate of the experimental group.
R0 resection rate	Up to approximately 30 days.	The R0 resection rate of the experimental group.
Pathologic complete response (pCR) rate	Up to approximately 30 days.	The pCR rate of the experimental group.
Major pathological response (MPR)	Up to approximately 30 days.	The MPR rate of the experimental group.
Safety	Up to approximately 90 days.	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Trial Locations

Locations (1)

the First Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China