Phase II Study of Concurrent Sorafenib and Intensity-modulated Radiotherapy (IMRT) for Advanced H… (NCT03535259) | Clinical Trial Compass
CompletedPhase 2
Phase II Study of Concurrent Sorafenib and Intensity-modulated Radiotherapy (IMRT) for Advanced Hepatocellular Carcinoma
China86 participantsStarted 2018-05-08
Plain-language summary
This is a single-arm phase II clinical trial to investigate the efficacy and toxicity of concurrent sorafenib and intensity-modulated radiotherapy (IMRT) for advanced hepatocellular carcinoma with portal vein or hepatic vein tumor thrombosis or lymph node involved. Eligibility patients will receive IMRT to hepatic primary tumor, vein tumor thrombosis, and metastasis lymph node with concurrently sorafenib with a dose of 400mg twice daily. Prescription of IMRT will be a conventional fraction dose of 2Gy to a total dose of 40 to 60Gy. Sorafenib will be maintained with a dose of 400mg twice daily after IMRT until disease progression, or unacceptable adverse events. Six months of sorafenib maintenance is recommended.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Clinical or histologic diagnosis of Hepatocellular carcinoma (HCC)
✓. Aged between 18 and 80 years
✓. ECOG 0-1
✓. Liver-GTV\>700ml
✓. BCLC stage C, HCC with portal vein or hepatic vein tumor thrombosis or lymph node involved (LN involved can be included one treatment planning)
✓. Estimated life expectancy \> 3 months
✓. Child-Pugh Score: A5-B8
✓. Hepatic function: alanine transaminase (ALT) and aspartate transaminase (AST)≤ 1.5 times ULN; or ALT ≤ ULN and AST≤ 6 times ULN exclude possibility of heart disease
Exclusion criteria
✕. Had prior abdominal irradiation
✕. Had prior liver transplantation
✕
What they're measuring
1
MST
Timeframe: 24 months
Trial details
NCT IDNCT03535259
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences