An prospective, open-label, random and control clinical trail of Apatinib combined with TACE contrast to the simple TACE in the treatment of recurrent hepatocellular carcinoma (HCC)

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-IPR-17012667

Enrollment

Unknown

Registered

2017-09-14

Start date

2017-09-18

Completion date

Unknown

Last updated

2017-10-02

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

Conditions

Liver cancer

Interventions

Apatinib combined with TACE test group:Apatinib Tablets orally

Control gruop:TACE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients with a histologic or cytologic diagnosis of hepatocellular carcinoma; 2. Patients with recurrence after surgery; 3. Unable or unwilling to re-surgical treatment; 4. No extrahepatic metastasis; 5. Child-Pugh Class A or B within 7 points; 6. Age =18 years old; 7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 2; 8. Life expectancy of at least 12 weeks; 9. The main organ function meeting the following: (1)blood routine examination meeting the standards (no blood transfusion and blood components support within 14 days, not using G-CSF and other hematopoietic stimulating factor correction: HB = 90 g/L; ANC = 1.5 × 10^9/L; PLT = 60×10^9/L; (2) blood biochemical examination meeting the following standards: TBIL <2 times the upper limit of normal (ULN); ALT and AST <5×upper limit of normal(ULN), serum Cr=1.5 times the upper limit of normal (ULN). 10. participants volunteered to participate in this study, signed informed consent, compliance, with follow-up.

Exclusion criteria

Exclusion criteria: 1. Hepatic cholangiocarcinoma and mixed cell carcinoma and fibrous lamellar cell carcinoma are known. Before(within 5years) or at the same time any, second malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix; 2. Prepared for liver transplantation(except for undergone liver transplantation before); 3. Patients with uncontrollable ascites Hepatic encephalopathy and Esophageal gastric varices bleeding(EGVB); 4. Patients with uncontrol hypertension in the use of two antihypertensive drugs (systolic blood pressure = 140 mmHg or diastolic blood pressure = 90 mmHg, despite optimal drug therapy); 5. Patients with grade ? myocardial ischemia or myocardial infarction, poor control of arrhythmias (including QTc interval male = 450 ms, female =470 ms); 6. There are several factors that affect oral medicine,such as unable to swallow, chronic diarrhea and intestinal obstruction; 7. Patients with a history or clear tendency of gastrointestinal bleeding in the period of 6 months can not be allowed to join the study; such as: tsophageal varices with bleeding risk ,local active ulceration,fecal occult blood test(++) 8. Cagulation abnormalities. Patients with bleeding tendency, receiving thrombolytics or anticoagulants; 9. Patients with central nervous system metastases or brain metastasis; 10. Positive urinary protein(uric albumen check(++),or Twenty-four hours urinary protein content>1.0g); 11. pregnant or lactating women; fertility patients are reluctant or unable to take effective contraceptive measures; 12. Patients with HIV infection; 13. Conditions determined by investigators to possibly affect the clinical study or determination of the study results.

Design outcomes

Primary

Measure	Time frame
PFS;	—

Secondary

Measure	Time frame
OS;DCR;ORR;QoL;	—

Countries

China

Contacts

Public ContactZheng Lu

Xinqiao Hospital, Chongqing

17449368@qq.com+86 13629720282

Outcome results

None listed

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