Trials / Unknown
UnknownNCT04962958
Hepatic Artery Infusion Chemotherapy Plus Donafenib in Patients With Hepatocellular Carcinoma After Surgery
Prospective, Single-arm, Multicenter Clinical Study of Hepatic Artery Infusion Chemotherapy With Donafenib for Adjuvant Treatment of HCC Patients With High Risk of Recurrence After Hepatectomy.
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is an open-label，multi-center ，non-randomized ，single arm exploratory study . This clinical study is an investigator-initiated clinical trial（IIT ）. The objective of this study is to evaluate if the addition of hepatic artery infusion chemotherapy (HAIC) and Donafenib after curative resection for hepatocellular carcinoma patients with a solitary tumor≥5 cm and microvascular invasion （MVI） will prevent or delay the recurrence of the disease.
Conditions
- Carcinoma
- Carcinoma, Hepatocellular
- Liver Neoplasms
- Digestive System Neoplasms
- Antineoplastic Agents
- Donafenib
- Fluorouracil
- Oxaliplatin
- Antimetabolites
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Hepatic arterial infusion chemotherapy | administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries |
| DRUG | Folfox Protocol | Oxaliplatin , fluorouracil, and leucovorin |
| DRUG | Donafenib | administration of Donafenib |
Timeline
- Start date
- 2023-07-01
- Primary completion
- 2024-03-01
- Completion
- 2024-08-01
- First posted
- 2021-07-15
- Last updated
- 2023-06-22
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04962958. Inclusion in this directory is not an endorsement.