SBRT+TACE+Sorafenib Vs Sorafenib in the Treatment of uHCC With PVTT (NCT04387695) | Clinical Trial Compass
UnknownPhase 3
SBRT+TACE+Sorafenib Vs Sorafenib in the Treatment of uHCC With PVTT
China54 participantsStarted 2020-04-30
Plain-language summary
To evaluate and compare the efficacy and safety of SBRT sequential TACE combined with sorafenib versus sorafenib alone in the treatment of unreactable HCC with PVTT.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Age \>18 years
* Child-Pugh score ≤ 7
* Performance status: ECOG score ≤ 2
* HCC diagnosed by biopsy or by the noninvasive criteria of the Chinese Liver Cancer Guideline 2017
* the primary HCC being unresectable (BCLC C stage/ CNLC â…¢a-b) according to NCCN guideline
* No previous therapy for HCC
* at least one measurable target lesion according to RECIST 1.1
* Adequate hematopoietic function: Hemoglobin ≥ 8.5 g/dL; Absolute neutrophil count ≥ 750/mm3; Platelet count ≥ 50,000/mm3
* Serum total bilirubin ≤ 2 x ULN
* Aspartate aminotransferase (AST) and alanine aminotransferase ≤ 10 x ULN
* Creatinine ≤ 1.5 x ULN
* No plan for pregnancy or breast feeding. Active contraception.
* Willing to give informed consent
Exclusion Criteria:
* Prior history to or exposure of transarterial chemoembolization, external beam radiation to liver, or sorafenib
* Complete obstruction of hepatic outflow
* Uncontrolled ascites of hepatic encephalopathy
* Prior liver transplantation
* Positive for human immunodeficiency virus (HIV)
* Active gastric or duodenal ulcer
* Other uncontrolled comorbidities or malignancy
* Inability to give informed consent
What they're measuring
1
Progression-free survival (PFS) rate
Timeframe: at 12 weeks after randomization
Trial details
NCT IDNCT04387695
SponsorFirst Affiliated Hospital of Zhejiang University