Advanced Hepatocellular Carcinoma
Conditions
Brief summary
This is a multicentri prospective cohort study to investigate the safety and efficacy of external beam radiation (RT) combined with transarterial chemoembolization (TACE) and lenvatinib vs TACE and lenvatinib in the treatment of advanced hepatocellular carcinoma (HCC) with portal vein tumor thrombus (PVTT).
Interventions
DRUGLenvatinib
Lenvatinib will be initially provided to patients first (dose: 8 mg qd for patients \< 60 kg, and 12 mg qd for patients ≥ 60 kg)
PROCEDURETACE
TACE will be performed one day after oral administration of lenvatinib. Either cTACE or DEB-TACE can be used, depending on the condition of each center.
RADIATIONExternal beam radiation (RT)
RT will be given within 4 weeks after the first TACE with linear accelerator-based photon beams. Gross tumor volume is defined as intrahepatic tumor and vascular invasion including a 1-cm margin into the contiguous HCC. Prescription dose will be 4500-6000 cGy in 25 fractions.
Sponsors
Sun Yat-sen University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. age 18-75 years; 2. histologically or cytologically or clinically confirmed diagnosis of HCC; 3. presenting with PVTT and at least one measurable intrahepatic lesion on the basis of modified Response Evaluation Criteria in Solid Tumors (mRECIST); an intrahepatic lesion consisting of a single tumor (≤ 10.0 cm) or multiple tumors (≤ 3 foci) with the tumor burden \< 50%; 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 5. Child-Pugh class A or B; 6. life expectancy of at least 3 months; 7. satisfactory blood, liver, and kidney function parameters. The acceptable blood, liver, and kidney parameters were (1) neutrophil count ≥ 1.5 × 109/L; (2) platelet count ≥ 60 × 109/L; (3) hemoglobin concentration ≥ 90 g/L; (4) serum albumin concentration ≥ 30 g/L; (5) bilirubin ≤ 50 μmol/L; (6) AST and ALT \< 5 × upper limit of normal (ULN) and alkaline phosphatase \< 4 × ULN; (7) extended prothrombin time \< 6 seconds of ULN; and (8) serum creatinine \< 1.5 × ULN.
Exclusion criteria
1. history of liver and adjacent tissue radiation; 2. medical history of hepatic decompensation, such as hepatic encephalopathy and esophageal or gastric variceal bleeding; 3. extrahepatic spread; 4. combination with other malignant diseases; 5. contraindications for TACE; 6. pregnant and lactating women; 7. severe dysfunction of the heart, kidney, or other organs; 8. hypersensitivity to intravenous contrast agents; 9. with HIV, syphilis infection; 10. allogeneic organ transplant recipients; 11. suffering from mental and psychological diseases may affect informed consent; 12. unable to take oral medication; 13. active gastric or duodenal ulcers within 3 months before enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Up to 2 years | OS is defined as the time from the first day of lenvatinib oral administration to death, regardless of disease recurrence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | Up to 2 years | PFS is defined as the time from the first day of lenvatinib oral administration to progression or death. |
| Objective Response Rate (ORR) | Up to 2 years | ORR is defined as the percentage of patients who have achieved complete response (CR) or partial response (PR), as measured by modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria. |
| Disease Control Rate (DCR) | Up to 2 years | DCR is defined as the percentage of patients who have achieved CR, PR or stable disease(SD), as measured by mRECIST criteria. |
| ncidence of Adverse Events (AE) | Up to 2 years | The percentage of patients who suffer adverse events from the first day of lenvatinib oral administration to last follow-up, assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. |
Countries
China
Outcome results
None listed