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A prospective and exploratory clinical study for predicting effect and analysing prognosis of TACE combined with apatinib in treatment of inoperable liver cancer

A prospective and exploratory clinical study for predicting effect and analysing prognosis of TACE combined with apatinib in treatment of inoperable liver cancer

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000030641
Enrollment
Unknown
Registered
2020-03-08
Start date
2020-11-01
Completion date
Unknown
Last updated
2020-05-18

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

Conditions

Hepatocellular carcinoma

Interventions

Observation group:TACE and apatinib

Sponsors

Sanxia Hospital Affiliated to Chongqing University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. With unresectable HCC (BCLC stage B and C) confirmed by imaging or histology; 2. Aged >=18 years male and female; 3. Child Pugh 5-6 grade A; 4. ECoG score 0-2; 5. The life expectancy exceeds 3 months; 6. Bone marrow function: neutrophil >= 1.5x10^9/L, platelet >= 75 x 10^9/L, hemoglobin >= 90g/L; 7. With liver and kidney function: serum creatinine <= 1.5 times the upper limit of normal value; AST and alt <= 5 times the upper limit of normal value; total bilirubin <= 1.5 times the upper limit of normal value; 8. Patients have good compliance with the planned treatment, can understand the research process of this study and sign the written informed consent voluntarily.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women, as well as childbearing age patients who refuse to take appropriate contraceptive measures during the trial; 2. Patients with sufficient lipiodol deposition and complete remission after TACE treatment; 3. Exclusion of contraindications to antiangiogenic drugs: (1) Those who have high blood pressure and cannot be controlled by antihypertensive drugs; (2) Urine routine showed positive protein >= + +; (3) There are many factors that affect oral medicine (inability to swallow, chronic diarrhea, intestinal obstruction, etc.); (4) Abnormal coagulation and bleeding tendency: for example, active ulcer, occult blood in stool (+ +); (5) Grade 3-4 cardiac insufficiency (NYHA standard); (6) Severe hepatorenal insufficiency (grade 4). 4. Having untreated central nervous system disease or symptomatic central nervous system metastasis disease; 5. According to the judgment of researchers, there are serious concomitant diseases endangering the safety of patients or affecting the completion of the study; 6. The estimated survival time is less than 3 months.

Design outcomes

Primary

MeasureTime frame
Time to progress;

Secondary

MeasureTime frame
Objective response rate;Progression free survival;

Countries

China

Contacts

Public ContactLiu Xuefen

Sanxia Hospital Affiliated to Chongqing University

lxfpd@sina.com+86 13908263750

Outcome results

None listed

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