TACE Combined With Methylcantharidimide Tablets in the Treatment of Large and Unresectable Hepatocellular Carcinoma
Sponsored by Suzhou Municipal Hospital
About this trial
Last updated 6 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Ended 4 years ago
What is this trial about?
What are the participation requirements?
Inclusion Criteria
1. Age range from 18-75 years;
2. KPS≥70;
3. The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL);
4. Simultaneously staged as BCLC A or BCLC B based on Barcelona Clinic Liver Cancer staging system;
5. Patients must have at least one tumor lesion that can be accurately measured;
6. Solitary tumor with diameter ≥10cm, or multiple tumors, diameter of the largest was more than 7cm;
7. Diagnosed as unresectable with consensus by the panel of liver surgery experts,
8. Re commanded treated by TACE with consensus by the panel of liver multi-disciplinary treatment (MDT);
9. No past history of TACE, chemotherapy or molecule-targeted treatment;
10. No Cirrhosis or cirrhotic status of Child-Pugh class A only;
11. No liver protection therapy in 2 weeks before enrolled, and meet the following laboratory parameters:(a) Platelet count ≥ 75,000/μL; (b)Hemoglobin ≥ 8.5 g/dL;(c) Total bilirubin ≤ 30mmol/L;(d) Serum albumin ≥ 32 g/L;(e) Glutamic pyruvic transaminase (ALT) and glutamic oxalacetic transaminase (AST) ≤ 6 x upper limit of normal;(f) Serum creatinine≤ 1.5 x upper limit of normal;(g) international normalized ratio(INR)> 2.3 or prothrombin time (PT)/activated partial thromboplastin time (APTT) within normal limits; (h) Absolute neutrophil count (ANC) >1,500/mm3;
12. Ability to understand the protocol and to agree to sign a written informed consent document.
Exclusion Criteria
1. Factors that affect oral administration, such as dysphagia, chronic diarrhea and intestinal obstruction;
2. Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry;
3. Known of serious heart disease which can nor endure the treatment such as cardiac ventricular arrhythmias requiring anti-arrhythmic therapy;
4. Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy;
5. Known history of HIV;
6. History of organ allograft;
7. Known or suspected allergy to the investigational agents or any agent given in association with this trial;
8. Evidence of bleeding diathesis;
9. Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug;
10. Serious non-healing wound, ulcer, or bone fracture;
11. Known central nervous system tumors including metastatic brain disease;
12. Poor compliance that can not comply with the course of treatment and follow up;
13. Factors that the researchers consider it not appropriate to be included