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A Randomized clinical control study of arsenic trioxide combined with topical minimally invasive technique in treatment for hepatocellular carcinoma

A Randomized clinical control study of arsenic trioxide combined with topical minimally invasive technique in treatment for hepatocellular carcinoma

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13004547
Enrollment
Unknown
Registered
2013-11-11
Start date
2014-04-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Primary liver cancer

Interventions

test group:Intravenous arsenic trioxide and topical minimally invasive technique
control group:topical minimally invasive technique

Sponsors

Radioactive intervention department, Jilin Province Cancer hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 years to 75 years, male or female; 2. the patients life expectancy at least for 3 months; 3. accord with liver cell carcinoma diagnosis standard (EASL of HCC diagnosis standard): cytohistology standard non-invasive standard (limited to patients with cirrhosis) 1, radioactive diagnosis standard: two kinds of image technology obtains the consistent conclusion lesions largger than 2 cm, rich in arteries 2, combined with diagnosis standard: a kind of image technology with the AFP lesions larger than 2 cm, rich in arteries AFP level more than 400 ug/L * can consider four technology: ultrasonic imaging, spiral CT, MRI and angiography; 4. liver lesions received local treatment of patients can be integrated into, including surgery, radiotherapy, and hepatic artery embolism, embolism chemotherapy, radiofrequency ablation, percutaneous ethanol injection or frozen ablation; 5. Once the patient if at the same time merge adrenal, bone, skin metastases are intended to be incorporated into this research scope, bone metastasis can also accept radiation therapy not systemic treatment; 6. Stuff in the Eastern part of patients with tumor clinical trials Group (Eastern Co - operative Oncology Group, ECOG) function status to 0, 1 or 2; 7. liver function Child - Pugh classification for class A or B level of patients; 8. laboratory index is as follows: 1) platelet count more than 60*1^09/L; 2) hemoglobin more than 8.5 g/dl; 3) albumin more than 3.0 g/dl; 4) total bilirubin acuities 3 mg/dl; 5) ALT and AST were less than three times the normal limit; 6) serum creatinine is less than 1.5 times the normal of the upper limit; 7) prothrombin time international standardization ratio (PT-INR) less than 2.3 or prothrombin time (PT) more than normal compared 6 seconds; 8) into the clinical research of the patients informed consent must be signed, patients should know he/she shall have the right at any time to test, and will not affect the subsequent treatment.

Exclusion criteria

Exclusion criteria: 1. expected survival period less than 3 months; 2. intrahepatic primary lesions did not get effective control, recent lesions in the liver increased obviously (a month tumor diameter increased 25%), or quantity increase; 3. known or suspected to be try drug allergy or to give this test related with any drug allergies; 4. at least 4 weeks received chemotherapy, target drug therapy; 5. before now or with a primary stove or histological does not comply with the liver cell cancer tumor; 6. Heatt disease need to accept therapy; 7. Congestive heart failure more than New York heart association (NYHA) level II; 8. activity of coronary artery disease (into the group of the first six months ago happen myocardial infarction patients coan into the group); 9. arrhythmia need to accept anti-arrhythmic therapy (B receptor-blockers, calcium ion antagonist or digoxin except); 10. cannot control hypertension (even using three kinds of antihypertensive drug treatment diastolic pressure still cannot control in 90 MMHG the following; 11. activity clinical serious infection (more than level 2 NCI - CTCAE3.0 version); 12. exist active tuberculosis, or not be excluded pulmonary tuberculosis in the lung lesions; 13. known central nervous system tumors, including brain metastatic tumor; 14. the patient group there were 30 days before clinical obvious gastrointestinal bleeding; 15. chronic renal failure; 16. any unstable condition or is likely to endanger the patient safety and he/she to research compliance; 17. Patients with pregnancy or lactation ;the women of childbearing age must have a pregnancy test before taking esperimental frugs in 7 days, and the results must be negative. The peron who participate in the project test must take a full birth control during the test.

Design outcomes

Primary

MeasureTime frame
Overall survival;Time to progression;

Secondary

MeasureTime frame
safety;Rate of cumulative incidence of relapse;Extrahepatic metastasis rate;Quality of life;

Countries

China

Contacts

Public ContactHui Wang
wanghuizlyy@sohu.com+86 13304317806

Outcome results

None listed

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