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Clinical study for effect and safety, as well as prognostic factors analysis of apapitatin mesylate combined with TACE in the treatment of patients with advanced hepatocellular carcinoma

Clinical study for effect and safety, as well as prognostic factors analysis of apapitatin mesylate combined with TACE in the treatment of patients with advanced hepatocellular carcinoma

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800017503
Enrollment
Unknown
Registered
2018-08-02
Start date
2018-08-31
Completion date
Unknown
Last updated
2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced hepatocellular carcinoma

Interventions

Case series:Apatinib monotherapy for maintenance treatment after TACE treatment

Sponsors

Daping Hospital, Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Histopathologically confirmed hepatocellular carcinoma; 2. Patients who have relapsed after surgery; 3. The patient is unsuitable or unwilling to undergo surgery again; 4. No extrahepatic metastasis; 5. Child-Pugh liver function rating to be grade A or better grade B (= 7 points); 6. Aged 18 years old or above, male or female; 7. ECOG PS 0-2 points; 8. The expected survival period is greater than or equal to 12 weeks; 9. The main organs function normally, that is, the following criteria are met: (1) Blood routine examination: (no blood transfusion within 14 days before screening, no use of G-CSF, no use of drugs to correct) HB=90 g/L; ANC=1.5× 10^9/L; PLT=75×10^9/L; (2) Biochemical examination: (ALB not input within 14 days) ALT and AST<5×ULN; TBIL =2×ULN; creatinine =1.5×ULN; 10. Subjects voluntarily participated in this study, signed informed consent, followed up with good compliance.

Exclusion criteria

Exclusion criteria: 1. Hepatic cholangiocarcinoma and mixed-cell carcinoma and fibrolamellar cell carcinoma have been diagnosed; in the past (within 5 years) or other untreated malignant tumors, except for cured skin basal cell carcinoma and cervical carcinoma in situ; 2. Patients who are ready for liver transplantation (except for patients who have undergone liver transplantation); 3. Difficult to control ascites, hepatic encephalopathy or esophageal varices bleeding; 4. People with high blood pressure who cannot be reduced to the normal range by antihypertensive medication (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg); 5. myocardial ischemia with above grade II or myocardial infarction, arrhythmia 6. A variety of factors affecting oral medications (such as inability to swallow, chronic diarrhea and intestinal obstruction, significantly affecting the use and absorption of drugs); 7. In the past 6 months, there is a history of gastrointestinal bleeding or a clear tendency to gastrointestinal bleeding, such as: esophageal varices with bleeding risk, local active ulcer lesions, fecal occult blood = (++) can not be included 8. Have a bleeding tendency or are receiving thrombolytic or anticoagulant therapy; 9. Patients with central nervous system metastases or known brain metastases have developed; 10. Urine routinely showed urinary protein = ++ or confirmed 24-hour urine protein quantitation > 1.0 g; 11. Pregnant or lactating women; those who have fertility are unwilling or unable to take effective contraceptive measures; 12. HIV infected patients; 13. The investigator determines other conditions that may affect the conduct of the clinical study and the outcome of the study.

Design outcomes

Primary

MeasureTime frame
progression-free survival;

Countries

China

Contacts

Public ContactDongfeng Chen

Daping Hospital, Army Medical University

742676160@qq.com+86 13023309167

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026