Hepatocellular Carcinoma
Conditions
Keywords
Hepatocellular carcinoma, Toripalimab, Stereotactic body radiotherapy, Portal vein tumor thrombus
Brief summary
To explore the efficacy and safety of toripalimab plus stereotactic body radiotherapy for hepatocellular carcinom with portal vein tumor thrombus.
Detailed description
Programmed Cell Death Protein-1 (PD-1) was effective and tolerable in patients with advanced hepatocellular carcinoma. Additionally, previous studies showed that stereotactic body radiotherapy (SBRT) was effective for hepatocellular carcinoma with portal vein tumor thrombus (PVTT). No study has evaluated the efficacy and safety of toripalimab plus SBRT for hepatocellular carcinoma with PVTT. Thus, the investigators carried out this prospective study to find out it.
Interventions
DRUGToripalimab
240mg intravenously every 3 weeks
RADIATIONStereotactic body radiotherapy
Radiotherapy dose was 36 \ 54Gy, divided into 6 times of irradiation, and the radiation was performed within 2 weeks.
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL) * Patients must have at least one tumor lesion that can be accurately measured according to mRECIST criteria * The normal liver volume in the non-target area was greater than 700ml * Portal vein tumor thrumbus confirmed in two image techniques * Eastern Cooperative Oncology Group performance status of 0 to 2 * No Cirrhosis or cirrhotic status of Child-Pugh class A only * With no previous radiotherapy and immunotherapy * Not applicable for transarterial chemoembolization, surgical resection, and local ablative therapy. * The following laboratory parameters: Platelet count ≥ 75,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/ L Serum albumin ≥ 30 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3 Ability to understand the protocol and to agree to and sign a written informed consent document
Exclusion criteria
* Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy * Known history of HIV * History of organ allograft * Known or suspected allergy to the investigational agents or any agent given in association with this trial. * Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * Evidence of bleeding diathesis. * Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * Known central nervous system tumors including metastatic brain disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival (PFS) | 6 months | PFS was defined as the time from the date of randomization to the date of first documentation of disease progression based on iRECIST, or date of death, whichever occurred first |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | 6 months | OS was defined as the duration from the date of randomization until the date of death from any cause. Participants who were lost to follow-up were censored at the last date the participant was known to be alive, and participants who remained alive were censored at the time of data cutoff. |
| Objective Response Rate (ORR) | 6 months | ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) based on iRECIST. CR was defined as disappearance of any intratumoral arterial enhancement in all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of viable (enhancement of arterial phase) target lesions taking as reference to the baseline sum of the diameters of target lesions. |
| Adverse Events | 6 months | Number of adverse events. Postoperative adverse events were graded based on CTCAE v4.03 |
Countries
China
Contacts
Primary ContactMing Shi, MD
Outcome results
None listed