HAIC Combine With Lenvatinib and PD-1 Inhibitors for Advanced HCC With PVTT (NCT05166239) | Clinical Trial Compass
CompletedPhase 2
HAIC Combine With Lenvatinib and PD-1 Inhibitors for Advanced HCC With PVTT
China66 participantsStarted 2022-01-10
Plain-language summary
The purpose of this study is to evaluate the safety and efficacy of hepatic arterial infusion chemotherapy combined with Lenvatinib and PD-1 inhibitors compared to Lenvatinib plus PD-1 inhibitors for advanced hepatocellular carcinoma (HCC) with portal vein tumor thrombosis (PVTT).
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Age and gender: \>18 years old and≤75 years old, both men and women.
✓. All subjects must have advanced hepatocellular carcinoma with portal vein tumor thrombosis confirmed by pathological or clinical diagnosis.
✓. One measurable lesion at least.
✓. ECOG PS 0-1 before 1 week of treatment begnining.
✓. Child-Pugh class A; ALBI class 1-2.
✓. Systemic-cheomtherapy-naive and HAIC-naive.
✓. BCLC C stage with PVTT (Vp1 - Vp4).
✓. Without distant metastasis.
Exclusion criteria
✕. Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma confirmed by histology or cytology.
✕. History of malignant tumor, excluding the following cases:
✕. Allergic to contrast agent.
✕. Allergic to oxaliplatin.
✕. History of usage of immune inhibitor drug within 14 days before the injection of PD-1 inhibitors, except nasal spray and inhaled corticosteroids or physiological doses of systemic steroid hormones (no more than 10 mg/day of prednisolone or other corticosteroids with equivalent physiological doses).
What they're measuring
1
6-month progression-free survival rate
Timeframe: From the date of treatment begining to the date of 6 months after the treatment begining.
✕. Factors influenced oral Lenvatinib, such as inability to swallow, chronic diarrhea and intestinal obstruction, or other conditions that significantly affect the administration and absorption of the drug.
✕. Allergic to Lenvatinib, PD-1 inhibitors, and other mono-colonal antibodies.
✕. Vaccination with live attenuated vaccine within 4 weeks before the first dose or planned during the study period.