IMRT Plus PD-1 Blockade and Lenvatinib for HCC With PVTT (Vp3) Before Liver Transplantation (NCT05339581) | Clinical Trial Compass
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IMRT Plus PD-1 Blockade and Lenvatinib for HCC With PVTT (Vp3) Before Liver Transplantation
China78 participantsStarted 2022-05-20
Plain-language summary
This is a parallel assigned, open-label, perspective trial studying the safety and efficacy of intensity-modulated radiotherapy (IMRT) combined with PD-1 Blockade and Lenvatinib for Hepatocellular Carcinoma (HCC) with Vp3 Portal Vein Tumor Thrombus (PVTT, Japanese Liver Cancer Study Group classification) before liver transplantation.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* Patients must have pathologically or cytologically or by radiological criteria proven hepatocellular carcinoma(exceeding Milan criteria); known mixed histology (e.g. hepatocellular carcinoma plus cholangiocarcinoma) or fibrolamellar variant is not allowed.
* The maximum diameter of a single tumor ≤9cm. Or the number of tumors ≤3 and the maximum diameter of the largest tumors ≤5cm, and the sum of the maximum diameters of all tumors ≤9cm.
* Vp3 PVTT according to Japanese Vp classification.
* Without lymph node metastasis or extrahepatic metastasis.
* Baseline AFP≥20ng/ mL
* Has an eligibility scan (CT of the chest, triphasic CT scan and MRI of the abdomen) \<1 week before the treatment.
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days prior to Cycle 1, Day 1.
* Has a Child-Pugh A-B7 liver score (5 to 7 points) within 7 days prior to Cycle 1, Day 1.
* Laboratory tests within 7 days prior to Cycle 1, Day 1:
* Neutrophils ≥1.5×109/L
* Hemoglobin ≥8.5g/dL
* Platelets ≥100×109/L,
* Creatinine ≤1.5× upper limit of normal (ULN) and endogenous creatinine clearance ≥50ml/min (standard Cockcroft Gaul formula)
* Total bilirubin ≤3×ULN, ALT≤5×ULN, AST≤5×ULN, INR≤1.7
* Has controlled hepatitis B (HBV-DNA\<105IU/ml)
* The estimate time length between enrollment and liver transplantation should be at least 3 months.
* No prior systematic therapy such as immunotherapy, targeted therapy and chemotherapy for HCC.
* No prior loca…