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Apatinib mesylate tablets combined with TACE in the treatment of advanced unresectable liver cancer: a real world study.

Apatinib mesylate tablets combined with TACE in the treatment of advanced unresectable liver cancer: a real world study.

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000040303
Enrollment
Unknown
Registered
2020-11-27
Start date
2020-11-20
Completion date
Unknown
Last updated
2021-02-16

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

Conditions

Liver Cancer

Interventions

Case series:Apatinib + TACE

Sponsors

Affiliated Hospital of Qingdao University Shandong Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years old; 2. Patients with unresectable hepatocellular carcinoma and intrahepatic cholangiocarcinoma who strictly comply with the clinical diagnostic criteria of "diagnostic and therapeutic criteria for primary liver cancer" (2019 Edition) or confirmed by histopathology or cytology; 3. At least one measurable lesion (according to RECIST version 1.1, the measurable lesion has a long diameter of >= 10 mm or a short diameter of an enlarged lymph node >=15 mm); the largest tumor is less than or equal to 10 cm; 4. Child Pugh liver function rating: A or B grade; 5. BCLC stage was B or C; 6. ECoG PS score: 0-2 points; 7. Expected survival time >=12 weeks; 8. HBV DNA =90 g/L; ANC>=1.5x10^9/L; PLT>=50x10^9/L; (2) Biochemical examination: ALB >=29 g/L; ALT and AST were < 5uln; TBIL <=2 ULN; Creatinine <=1.5 ULN; 10. Women of childbearing age should be given pregnancy test within 7 days before enrollment; 11. The subjects volunteered to join the study, signed the informed consent form, had good compliance and cooperated with the follow-up.

Exclusion criteria

Exclusion criteria: 1. Mixed cell carcinoma and fibrolamellar cell carcinoma; previously (within 5 years) or at the same time suffering from other untreated malignant tumors, except for skin basal cell carcinoma and cervical carcinoma in situ; 2. Patients who are ready for liver transplantation (except those who have received liver transplantation before); 3. Ascites with clinical symptoms need therapeutic abdominal puncture or drainage, or child Pugh score > 2; 4. Patients with hypertension who can not be reduced to normal range after antihypertensive drug treatment (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); 5. Patients with grade II or above myocardial ischemia or myocardial infarction and arrhythmia with poor control (including QTc interval >=450 ms in male and >=470 MS in female); 6. According to NYHA standard, grade III-IV cardiac insufficiency or echocardiography: LVEF =+ +, can not be included in the group; if fecal occult blood (+), gastroscopy is required; 9. Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 28 days before the study; 10. Abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds) with bleeding tendency or undergoing thrombolytic or anticoagulant therapy; 11. Urine routine examination showed urine protein >= + +, or confirmed 24-hour urine protein quantity > 1.0 G; 12. Received strong CYP3A4 inhibitor treatment within 7 days before participating in the study, or received strong CYP3A4 inducer treatment within 12 days before participating in the study; 13. Pregnant or lactating women; fertile patients who are unwilling or unable to take effective contraceptive measures.

Design outcomes

Primary

MeasureTime frame
efficacy and safety;

Countries

China

Contacts

Public ContactSong Wang

Affiliated Hospital of Qingdao University

15662629180@163.com+86 15662629180

Outcome results

None listed

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