Lenvatinib Plus TACE Versus Sorafenib Plus TACE for HCC With PVTT

• Status: Enrolling by invitation
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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 diagnosed in China in 2020. HCC represents approximately 90% of all cases of primary liver cancer. HCC has a high predilection for portal vein invasion, which occurs in 44-62% of living patients with HCC. Patients with PVTT usually have an aggressive disease course, decreased liver function reserve, limited treatment options, thus worse overall survival. Among untreated HCC patients with PVTT, the median overall survival has been reported as low as 2 to 4 months with supportive care. Sorafenib is the first-line treatment for HCC patients with PVTT, however, it has shown unsatisfactory benefit. Notably, sorafenib combined with TACE significantly improved the TTP over sorafenib alone, albeit for no more than 1 month in the median TTP, and the median OS was not significantly prolonged. A promising drug-lenvatinib was approved in China on September 2018, in the China patients subgroup analysis showed an encouraging results. Lenvatinib group had showed a significant benefit in TTP, PFS and ORR. Also median overall survival time was significantly improved in China subgroup (Lenvatinib group: 15 months VS Sorafenib group: 10.2 months). However, REFLECT didn't enrolled patients who had tumors invading the maint portal vein. The mechanisms of lenvatinib or sorafenib combined with TACE were still unknown, and clinical data were limited.

This study was to explore lenvatinib plus TACE versus sorafenib plus TACE for HCC with PVTT:

efficacy and safety. Biomarkers expression of VEGFR, FGFR, FDGF-α, IL-2,etc would be detected to find the difference between the two groups, finally to analyze the relationship between clinical outcomes and biomarkers' expression. A better treatment modality to HCC with PVTT patients would be expected and promoted.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Ditan Hospital
• Treatments: Chlorotrianisene; Lenvatinib; Sorafenib

Criteria

Inclusion Criteria

1. Histologically or cytologically proven HCC.

2. HCC complicated by PVTT.

3. Patient had not received previous systemic therapy.

4. At least one measurable tumor along a single dimension according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST).

5. 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.

6. Patients had not history of previous local therapy such as radiotherapy, hepatic arterial embolisation, chemoembolisation, RFA, percutaneous injection, or cryoablation.

7. Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 or 1;

8. Child-Pugh class A or Child-Pugh class B (score 7).

9. All patients were voluntary, and signed informed agreement.

Exclusion criteria

1. Previous or concomitant systemic therapy (including molecularly targeted therapies).

2. Known history of HIV infection.

3. Clinically serious infections.

4. Administered warfarin as an anticoagulant.

5. History of organ allograft.

6. History of cardiac disease.

7. Known central nervous system tumour.

8. Known gastrointestinal bleeding up to 30 days before study enrolment,

9. Pregnancy or breastfeeding.