Clinical trial NCT06739317: SBRT Combined with Camrelizumab and Apatinib for Conversion Therapy in Patients with Unresectable Hepatocellular Carcinoma.
Official title: •Stereotactic Body Radiotherapy Combined with Camrelizumab and Apatinib As Conversion Therapy Versus Camrelizumab Combined with Apatinib As First-Line Therapy for Unresectable Hepatocellular Carcinoma: a Prospective, Multicenter, Open-label, Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Unresectable Hepatocellular Carcinoma (HCC)
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 398
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Overall Survival
timeFrame: Up to approximately 3 years
measure: The R0 Resection rate of the experimental group
timeFrame: Up to approximately 30 days
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to approximately 3 years
measure: Disease control rate (DCR)
timeFrame: Up to approximately 3 years.
measure: Time to Response (TTR)
timeFrame: Up to approximately 3 years.
measure: Duration of response (DoR)
timeFrame: Up to approximately 3 years.
measure: Time to progression (TTP)
timeFrame: Up to approximately 3 years.
measure: Event free survival (EFS)
timeFrame: Up to approximately 3 years.
measure: Conversion rate
timeFrame: Up to approximately 30 days.
measure: Resection rate
timeFrame: Up to approximately 30 days.
measure: R0 resection rate
timeFrame: Up to approximately 30 days.
measure: Pathologic complete response (pCR) rate
timeFrame: Up to approximately 30 days.
measure: Major pathological response (MPR)
timeFrame: Up to approximately 30 days.
measure: Safety
timeFrame: Up to approximately 90 days.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: the First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References: