Clinical trial · Interventional
A Multicenter Study of Anlotinib in Hepatocellular Carcinoma (HCC) Patients at High Risk of Post Surgery Recurrence
A Single Group, Open Label, Multi-center Clinical Study to Assess the Efficacy and Safety of Anlotinib in HCC Patients at High Risk of Post Surgery Recurrence.
NCT03945799CI-TRIAL-00060619terminatedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study has gotten preliminary results and stopped advanced.
Summary
Brief summary (as posted)
To assess the primary effects and safety of Anlotinib in HCC patients at high risk of post surgery recurrence.
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 |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anlotinib Hydrochloride | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Anlotinib
- description
- Administration Anlotinib and it should be continued until relapse of HCC or intolerable toxicity or patients withdrawal of consent.
- interventionNames
- Drug: Anlotinib Hydrochloride
Primary outcomes (1)
- measure
- Disease free survival
- timeFrame
- From randomization to recurrence of HCC or death (up to 1year)
- description
- The period from resection surgery to recurrence of HCC
Secondary outcomes (2)
- measure
- Adverse effect
- timeFrame
- Up to 1year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * No allergic history of Anlotinib * 18-75 years * No history of severe arrhythmia or heart failure * No history of severe ventilation dysfunction or severe pulmonary infection * No acute or chronic renal failure, creatinine clearance \> 40 mL/min * Liver function is normal: child-pugh grade A or grade B (≤7 points), total bilirubin ≤ 3.0 mg/dL, albumin ≥ 28 g/L, AST, ALT, ALP≤ 5 times of the upper limit of normal value * Blood test: the absolute neutrophil count ≥ 1.5×10\^9 /L, Hb ≥ 8.5 g/L, PLT ≥ 75×10\^9 /L (without blood transfusions and drug therapy 14 days before the screening) * Blood coagulation function: INR≤2.3 * ECOG: 0-2 * Pathology: hepatocellular carcinoma * Satisfy any of the following: A. portal vein, hepatic vein or bile duct carcinoma thrombus B. microvascular invasion (MVI) grade II (\> 5 MVI, or MVI occurs in the area more than 1 cm from the tumor) C. tumor number ≥ 3 D. preoperative rupture of tumor or tumor invasion adjacent organs * Patients participate in the study voluntarily and sign informed consent Exclusion Criteria: * Pregnant or lactating women * Patients who have had or are currently complicated with other malignant tumors * Recurrent hepatocellular carcinoma * Patients who participated in other clinical trials within 1 month * Patients with mental illness * Patients treated with targeted drugs, immunotherapy (such as PD1 antibody), FOLFOX systemic chemotherapy or huaier granules after surgery * Urine protein ≥ ++，and 24-hour urinary protein excretion\>1.0 g confirmed
References
Publications (0)
Data not yet available
No reference posted for this study.