Clinical trial · Interventional
Study of Apatinib Combined With TACE in Advance Hepatocellular Carcinoma
NCT03398122CI-TRIAL-00031169HCCunknownN/AClinicalTrials.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)
the purpose of this study is to evaluate the efficacy and safety of aptinib in patients with advanced HCC
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apatinib | Drug | — | UNRESOLVED |
| TACE | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Apatinib combined with TACE
- description
- patients received Aptinib, 250 mg daily after TACE treatment, for 4-6 weeks
- interventionNames
- Procedure: TACE
- Drug: Apatinib
- type
- PLACEBO_COMPARATOR
- label
- chemoemtranscatherer arterial bolization
- description
- epirubicin 30-60mg was injected into the blood supply artery of the tumor ,Embolization was subsequently performed with granules of gelatin sponge particles.
- interventionNames
- Drug: Apatinib
Primary outcomes (1)
- measure
- PFS
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age: 18-70 years old; 2. initial treatment diagnosed by histopathological or cytological examination BCLC Staging B/C Hepatocellular carcinoma of the liver ( HCC ) and at least one of the largest tumors in measurable lesions ≤15cm ; 3. Child-pugh liver function Rating: A level, B level; 4. BCLC Staging as B / C period; 5. before join in the group 1 weeks ECOG PS Rating: 0-1 score; estimated Lifetime ≥12 Week; Lab metrics meet the following criteria: ( 1 ) Blood routine check: 1. HB≥90 g/L; 2. ANC≥1.5x109/L; 3. PLT≥60x109/L; ( 2 ) Biochemical Examination: <!-- --> 1. ALB≥29 g/L; 2. ALT and AST\<2.5\*ULN; 3. TBIL ≤ 2\*ULN; 4. Cr ≤ 1.5\*ULN; 6. women of childbearing age must be pregnancy tests before join in the group in 7 days; 7. Participants volunteered to join this study should sign informed consent, with good compliance and follow-up. Exclusion Criteria: 1. Central hepatic artery / hepatic venous fistula in patients with hepatocellular carcinoma, diffuse liver cancer patients, with large vascular invasion of liver cancer patients (including portal vein tumor thrombus); 2. hepatobiliary cell carcinoma and mixed cell carcinoma are known; previous ( 5 year) or at the same time suffering from other incurable malignancies, except for the cured basal cell carcinoma of the skin and cervical carcinoma in situ; 3. clinically symptomatic ascites that requires therapeutic celiac puncture or drainage with high blood pressure and cannot be reduced to normal range by anti hypertensive medications (systolic pressure \> 140 mmHg , diastolic pressure \>90 mmHg ); 4. Suffering Ⅱ above-level myocardial ischemia or myocardial infarction, control of poor arrhythmia (including QTC inter-phase male ≥450 ms , female ≥470 ms ); 5. Follow NYHA Standard Ⅲ \~ Ⅳ grade heart insufficiency or heart color Doppler ultrasonography: LVEF (left ventricular ejection fraction) \< 50% ; 6. There are various factors affecting oral medication (e.g.inability to swallow, chronic diarrhea and intestinal obstruction, which significantly affect drug use and absorption); 7. previous within 6 months there is a history of gastrointestinal bleeding or a clear tendency to gastrointestinal bleeding, such as: bleeding risk of esophageal varices, local active ulcer lesions, fecal occult blood ≥ ( ++ ) not in group; fecal occult blood (+ ), requiring gastroscopy; 8. before participating in this study There were abdominal fistula, gastrointestinal perforation or celiac abscess in the day; 9. Coagulation dysfunction ( INR \> 1.5 or prothrombin time ( PT ) \> ULN+4 seconds), with bleeding tendencies or undergoing thrombolysis or anticoagulant therapy; 10. patients who have undergone central nervous system metastasis or known brain metastases; 11. patients with objective evidence of the history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, and severe lung impairment; 12. urine proteins are routinely shown ≥++ or confirmed 24 hour urine protein ration \> 1.0 g ; 13. before participating in the study 7 days use strong-effect in CYP3A4 inhibitor therapy, or prior to participating in the study 12 days use the strong-effect in CYP3A4 inducer Therapy; 14. pregnant or lactating women who are not willing or unable to take effective contraceptive measures; 15. A history of mental illness, or psychotropic substance abuse; 16. Union HIV infected patients;
References
Publications (0)
Data not yet available
No reference posted for this study.