Unresectable Hepatocellular Carcinoma (HCC)
Conditions
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.
Interventions
RADIATIONRadiation
Subjects receive Stereotactic Body Radiotherapy combined with Camrelizumab and Apatinib as conversion therapy.
Subjects receive Camrelizumab intravenously. Subjects receive Apatinib orally.
PROCEDUREoperation
If subjects suitable for hepatic resection after conversion therapy, radical surgery and postoperative adjuvant therapy will be performed.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Objective Response Rate (ORR) | Up to approximately 3 years | The ORR is assessed by the investigators according to RECIST v1.1 and mRECIST, respectively. |
| 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 |
| Resection rate | Up to approximately 30 days. | The resection rate of the experimental group. |
| Disease control rate (DCR) | Up to approximately 3 years. | The DCR is assessed by the investigators according to RECIST v1.1 and mRECIST, respectively. |
Countries
China
Contacts
Primary ContactMing Kuang
Backup ContactLixia Xu
Outcome results
None listed