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A comparative study in the efficacy of less than 5cm liver cancer between TACE sequential MWA and TACE by As2O3-PLGA microspheres

A comparative study in the efficacy of less than 5cm liver cancer between TACE sequential MWA and TACE by As2O3-PLGA microspheres

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-17012159
Enrollment
Unknown
Registered
2017-07-27
Start date
2017-01-01
Completion date
Unknown
Last updated
2017-08-21

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

Conditions

less than 5cm liver cance

Interventions

Control group:TACE by As2O3-PLGA microspheres
experimental group:TACE sequential with MWA

Sponsors

The First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. The diagnosis of hepatocellular carcinoma in patients is confirmed by histopathology, or qualify as the clinical diagnosis and staging criteria of primary liver cancer in China. Non-resectable or non-surgical HCC patients; According to the requirement of RECIST 1.1, it was required to measure the diameter of the spiral CT scan of the lesion with a diameter of more than 10mm or enlarged lymph node with a short diameter of 15mm. The maximum tumor is less than 5cm; No portal vein trunk completely blocked; 2. Tumor Stage: BCLC stage B - C stage; 3. male or female aged between 18 and 75 years old; 4. one week between accepted the ECOG PS scores: 0-1,KPS 60; 5. The percentage of liver tumor was 75% smaller than that of the whole liver, and the life expectancy was 3 months; 6. there are no serious complications, such as high blood pressure, coronary heart disease and history of mental illness,serious allergies; 7. The liver function should reach the child-pugh grade A or B, the renal function is normal, the coagulation function is normal or corrected after treatment; 8. HBV DNA < 2000 IU/ml (104 copies/ml); 9. Childbearing age Women shall undergo pregnancy test within 7 days prior to the entry of the group; 10. The patient signed the informed consent to participate in the experimental study; Can follow up, compliance is good.

Exclusion criteria

Exclusion criteria: Patients who meet the following 1 or several are not involved in this study 1. It has been known as hepatic cholangiocarcinoma and mixed cell carcinoma and fibroblastic cell carcinoma. In the past (5 years) or at the same time, there are other uncured malignancies, except for the treated skin basal cell carcinoma and cervical carcinoma in situ; Diagnosis of liver cancer but widespread metastasis; 2. In the four weeks prior to the study, any local treatment other than TACE was accepted; 3. Severe hepatocellular jaundice, liver failure, massive ascites, uncontrolled infection; 4. Severe heart, lung, kidney disease, severe uncorrected coagulant dysfunction; 5. In the past six months, there was a history of gastrointestinal bleeding or a clear tendency of gastrointestinal bleeding. During the 28 days before the study, abdominal fistula, gastrointestinal perforation or abdominal abscess occurred; 6. Pregnant or lactating patients; Patients with liver transplantation (except patients with previous liver transplantation); 7. The whole body is in decline, and the survival period is expected to be < 3 months; 8. The patient was unable to complete the treatment for various reasons and was unable to follow up in 3 months.

Design outcomes

Primary

MeasureTime frame
Overall Survival;Disease Control Rate, DCR;Time To Progress, TTP;

Countries

China

Contacts

Public ContactHan Xinwei

The First Affiliated Hospital of Zhengzhou University

hanxinwei2006@163.com+86 13803842129

Outcome results

None listed

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