Trials / Unknown
UnknownNCT04237740
Relenvatinib in the Tatment of Recurrence of Hepatocellular Carcinoma After Liver Transplantation
Evaluation of the Efficacy and Safety of Relenvatinib in the Tatment of Recurrence of Hepatocellular Carcinoma After Liver Transplantation: a One-arm, Open-label Study
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- RenJi Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this study is to evaluate the efficacy and safety of lenvatinib in the treatment of recurrence of hepatocellular carcinoma after liver transplantation.
Detailed description
The research is an open, one-arm, single-center study. 40 patients with recurrence of hepatocellular carcinoma after liver transplantation are included according to the criteria of admission. The enrolled patients are treated with lenvatinib (dose: body weight \< 60 kg: 8 mg/day, body weight ≥ 60 kg 12 mg/day). The baseline data of patients are collected before allocation. Serum and imaging examination are checked regularly every month to monitor the recurrence of hepatocellular carcinoma and the side effects of lenvatinib. The efficacy and safety of lenvatinib in the treatment of recurrence of hepatocellular carcinoma are observed, and the clinicopathological factors affecting the efficacy of lenvatinib are analyzed. When side effects of lenvatinib occur, the dosage can be reduced according to the patients' condition until discontinuation. When tumor advances, a multidisciplinary team will draw up specific treatment plans according to the patients' condition.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | relenvatinib | The enrolled patients are treated with lenvatinib (dose: body weight \< 60 kg: 8 mg/day, body weight ≥ 60 kg 12 mg/day). |
Timeline
- Start date
- 2020-05-01
- Primary completion
- 2022-01-01
- Completion
- 2022-11-01
- First posted
- 2020-01-23
- Last updated
- 2020-03-24
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04237740. Inclusion in this directory is not an endorsement.