Clinical trial · Interventional
TACE Combined With Anlotinib Treatment of Middle-advanced Hepatocellular Carcinoma (HCC) Patients
A Single-center Randomized Controlled Clinical Trial of TACE Combined With Anlotinib Comparing With TACE in the Treatment of Middle-advanced Hepatocellular Carcinoma (HCC) Patients
NCT04066543CI-TRIAL-00040224unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study was designed to evaluate the effectiveness of Anlotinib in middle-advanced Hepatocellular Carcinoma (HCC) Patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anlotinib Hydrochloride | Drug | — | UNRESOLVED |
| TACE | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- TACE group
- description
- Device: Transcatheter arterial chemoembolization(TACE)
- interventionNames
- Device: TACE
- type
- EXPERIMENTAL
- label
- TACE+Anlotinib group
- description
- Device: Transcatheter arterial chemoembolization Drug: Anlotinib Anlotinib hydrochloride capsule, according to the recommended dose, po, qd, continuous oral 2 weeks stop for 1 week, 3 weeks for a cycle.
- interventionNames
- Device: TACE
- Drug: Anlotinib Hydrochloride
Primary outcomes (1)
- measure
- PFS
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subject has no contraindication to chemotherapy, and has no obvious obstacles in the function of major organs such as heart, lung, liver and kidney; 2. Subject has middle-advanced liver cancer of Barcelona Clinic Liver Cancer stages B/C ; 3. Liver function child-pugh class A or B; Karnofsky (KPS) score \> 60 points; 4. Subject could not accept surgical resection or refuse surgical operation;and who did not receive other treatment before operation. 5.18\~75 years old; ECOG PS score: 0-1 points; expected survival period is more than 3 months. Exclusion Criteria: 1. Subject has contraindications to chemotherapy; 2. Subject has obstacle in the function of major organs such as heart, lung, liver and kidney; 3. Severe coagulation dysfunction (prothrombin time \> 18 s or hemorrhagic tendency); 4. Uncontrollable hypertension and portal hypertension; 5. Hepatic artery-portal vein or hepatic vein fistula or portal vein trunk cancer thrombus; 6. A large amount of ascites or refractory ascites; 7. With distant metastasis.
References
Publications (1)
- DERIVEDZhang D, Zhang Z, Luo J, Zheng J, Mao X, Tsilimigras DI, Chun HJ, Zeng H. Efficacy and safety of transarterial chemoembolization alone compared to its combination with anlotinib among patients with intermediate or advanced stage hepatocellular carcinoma: a phase II randomized controlled trial. J Gastrointest Oncol. 2024 Aug 31;15(4):1627-1635. doi: 10.21037/jgo-24-497. Epub 2024 Aug 28. PMID 39279973