drugset / Trial / NCT03971201
A Randomized Phase II Trial of Surgery Plus Sorafenib vs. Sorafenib Alone for Hepatocellular Cancer (HCC) With Portal Vein Invasion
Phase 2
Unknown
200 enrolled
White Plains Hospital
Anhui Provincial Hospital · collabCancer Hospital of Guangxi Medical University · collabEastern Hepatobiliary Surgery Hospital · collabFujian Cancer Hospital · collabSun Yat-sen University · collabWenzhou People's Hospital · collabWest China Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Patients with HCC with portal vein involvement not involving the bifurcation (vP1-vP3) and no evidence of extra-hepatic spread will be enrolled. Patients will be required to have Child's A liver function and no significant portal hypertension. Patients will be randomly assigned with a 1:1 ratio to either surgery followed by adjuvant sorafenib or sorafenib alone. Patients will be followed by serial imaging. The primary end-point is overall survival.
Timeline
- Start
- 2019-09-06
- Primary completion
- 2022-12-31
- Completion
- 2023-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sorafenib | Small molecule | — | — |