Status:
UNKNOWN
Lenvatinib Plus TACE Versus Sorafenib Plus TACE for HCC With PVTT
Lead Sponsor:
Beijing Ditan Hospital
Conditions:
Carcinoma, Hepatocellular
Portal Vein Tumor Thrombus
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
Hepatocellular carcinoma (HCC) is the fourth most common cancer in China, with a crude incidence rate of 26.67 per 100,000 population. Moreover, 357,800 new liver cancer cases are predicted to be diag...
Detailed Description
Hepatocellular carcinoma (HCC) is the fourth most common cancer in China, with a crude incidence rate of 26.67 per 100,000 population. Moreover, 357,800 new liver cancer cases are predicted to be diag...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Histologically or cytologically proven HCC.
- HCC complicated by PVTT.
- Patient had not received previous systemic therapy.
- At least one measurable tumor along a single dimension according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST).
- WBC ≥ 3.0\*109/L，PLT≥70\*109/L，Hgb≥80\*109/L；ALT≤2.5ULN，AST≤2.5ULN，TBIL≤3ULN，ALB≥28g/L；CCr ≥80ml/min.
- Patients had not history of previous local therapy such as radiotherapy, hepatic arterial embolisation, chemoembolisation, RFA, percutaneous injection, or cryoablation.
- Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 or 1;
- Child-Pugh class A or Child-Pugh class B (score 7).
- All patients were voluntary, and signed informed agreement.
- Exclusion criteria
- Previous or concomitant systemic therapy (including molecularly targeted therapies).
- Known history of HIV infection.
- Clinically serious infections.
- Administered warfarin as an anticoagulant.
- History of organ allograft.
- History of cardiac disease.
- Known central nervous system tumour.
- Known gastrointestinal bleeding up to 30 days before study enrolment,
- Pregnancy or breastfeeding.
Exclusion
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04127396
Start Date
September 1 2019
End Date
December 1 2021
Last Update
July 23 2021
Active Locations (1)
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1
Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100011