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This is a Phase II , Open-label , Investigator-initiated Trail of SBRT in Combination With Adbelimumab and Apatinib in Patients With Hepatocellular Carcinoma(HCC).This study aims to evaluate the safety and efficacy of SBRT in Combination With Adbelimumab and Apatinib as a preoperative and conversion treatment of HCC.
This is an Open, Two Arm, Exploratory and Phase II Clinical Trial of SBRT Combined With Adbelimumab (an Anti-PD-L1 Inhibitor) and Apatinib in Patients With Hepatocellular Carcinoma(HCC) as Perioperative and Conversion Treatment. we conduct this study in order to observe and evaluate the efficacy and safety of SBRT Combined With Adbelimumab and Apatinib in treatment of patients with HCC. Primary Efficacy Endpoint: Perioperative cohort-Pathological complete response Rate (pCR); Conversion cohort-Objective Response(ORR) (According to RECIST Version 1.1).Secondary Efficacy Endpoints:Perioperative cohort-Major pathologic response (MPR) ,Event-free survival (EFS) and Overall survival (OS );Conversion cohort-Radical (R0) resection rate,Disease control rate (DCR),Progression free survival(PFS) and Overall survival (OS ).Safety and tolerance will be evaluated by incidence, severity and outcomes of AEs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perioperative queue | Experimental | SBRT: SBRT: 8-30Gy/1-6F(dose is determined according to the tumor diameter); Adbelimumab: 2-3 cycles of neoadjuvant therapy before surgery, 1200mg iv d1 q3w; Apatinib : D1-D21 : 250 mg, orally, qd; Before surgery, the patient's surgical pathology samples still need to be collected. After surgery, patients would receive Adbelimumab and Apatinib as adjuvant therapy .No more than 17 cycles before and after surgery. |
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| Conversion queue | Experimental | SBRT: tumor thrombus dose 30Gy /5-6F; Primary tumor dose is referred to Perioperative queue; Adbelimumab: 1200mg iv d1 q3w; Apatinib : D1-D21 : 250 mg, orally, qd; Treatment continues till PD,death,intolerable toxicity,or meet the criteria for Successful transformation(the maximum duration of adbelizumab combined with Apatinib conversion therapy was 1 year). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adbelimumab | Drug | adbelimumab:1200mg iv d1 q3w |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete response Rate (Perioperative cohort) | No histologic evidence of malignancy or only the ingredients of carcinoma in situ was found in primary tumors | 4 months |
| Objective Response (Conversion cohort) | It is defined as the proportion of patients whose tumors shrink to a predetermined size and maintain a minimum time limit. It includes the cases of CR and PR. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Event-free survival | Refers to the time from the start of the group to the occurrence of any event | 5 year |
| Major pathologic response | It is defined as residual tumors less than 10% after neo-adjuvant therapy |
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Inclusion Criteria:
The patient volunteered to participate in the study and signed an informed consent form
≥18 years of age,Male or female
Subjects are diagnosed with histologically or cytologically confirmed HCC
Subjects haven't received any systemic treatment for HCC before admission.
Subjects enrolled must have measurable lesion(s) according to the RECIST 1.1 standard
ECOG performance status of 0 or 1
Life expectancy ≥ 12 weeks
Subjects are diagnosed with resectable stage IB- IIIA HCC cancer.
The main organ's function is normal and it should meet the following criteria(Excludes use of any blood components and cell growth factors during the screening period)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jingfeng Liu, DR | Contact | 13905029580 | drjingfeng@126.com | |
| Yu Chen, DR | Contact | 13859089836 | chenyu1980@fjmu.edu.cn |
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| SBRT |
| Procedure |
SBRT: SBRT: 8-30Gy/1-6F(dose is determined according to the tumor diameter); tumor thrombus dose 30Gy /5-6F; |
|
| apatinib | Drug | apatinib:250mg po, qd |
|
| 4 months |
| Overall survival | It is defined as the time from randomization to death from any cause during the course of the study | 5 year |
| Safety as measured by the rate of AEs | Safety will be evaluated by incidence, severity and outcomes of adverse events (AEs) | 1 month |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| C553458 | apatinib |
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