TACE Combined With Methylcantharidimide Tablets in the Treatment of Large and Unresectable Hepatocellular Carcinoma

NCT ID: NCT03996681

Last Updated: 2019-06-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-20
• Study Completion Date: 2021-02-01

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of transarterial chemoembolization (TACE) combined with methylcantharidimide tablets in the treatment of patients with large and unresectable hepatocellular carcinoma.

Detailed Description

Most guidelines recommend transarterial chemoembolization (TACE), as the standard of care for unresectable hepatocellular carcinoma (HCC ) at Barcelona Clinic Liver Cancer (BCLC) stage A-B. While a number of studies demonstrate poor effect of TACE for patients with large hepatocellular carcinoma. The efficacy of TACE on large (≥ 10 cm) stage A-B HCC is far from satisfactory. The median overall survival was only 6.5-9.1 months. Methylcantharidimide is a single molecule drug used for the treatment of primary liver cancer.

Thus, the investigators carried out this prospective trial to demonstrate the efficacy and safety of TACE combined with methylcantharidimide tablets in patients with large and unresectable hepatocellular carcinoma.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TACE plus methylcantharidimide tablets

Methylcantharidimide tablets( 75mg po tid) is administered before first TACE 3 days and taken continuously after TACE treatment. Every 6 weeks is a cycle.

Group Type: EXPERIMENTAL

methylcantharidimide tablets

Intervention Type: DRUG

Drug: methylcantharidimide tablets

Methylcantharidimide is a single molecule drug used for the treatment of primary liver cancer.

Procedure: TACE

Transcatheter arterial chemoembolization was performed by the injection of small embolic particles coated with chemotherapeutic agents selectively into an artery directly supplying a tumor.

Interventions

methylcantharidimide tablets

Drug: methylcantharidimide tablets

Methylcantharidimide is a single molecule drug used for the treatment of primary liver cancer.

Procedure: TACE

Transcatheter arterial chemoembolization was performed by the injection of small embolic particles coated with chemotherapeutic agents selectively into an artery directly supplying a tumor.

Intervention Type: DRUG

Other Intervention Names

GANYU

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suzhou Municipal Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lei Chen

vice president of hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lei Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Suzhou Municipal Hospital

Locations

Suzhou Municipal Hospital

Suzhou, Jiangsu, China

Countries

China

Central Contacts

Lei Chen, MD

Role: CONTACT

leichensz@sina.com

+86-13771775313

Mo Zhou

Role: CONTACT

szslyyec@163.com

+86 0512-62362596

Facility Contacts

Mo Zhou, MD

Role: primary

szslyyec@163.com

+86 0512-62362596

References

He MK, Le Y, Li QJ, Yu ZS, Li SH, Wei W, Guo RP, Shi M. Hepatic artery infusion chemotherapy using mFOLFOX versus transarterial chemoembolization for massive unresectable hepatocellular carcinoma: a prospective non-randomized study. Chin J Cancer. 2017 Oct 23;36(1):83. doi: 10.1186/s40880-017-0251-2.

Reference Type: BACKGROUND

PMID: 29061175 (View on PubMed)

Xue T, Le F, Chen R, Xie X, Zhang L, Ge N, Chen Y, Wang Y, Zhang B, Ye S, Ren Z. Transarterial chemoembolization for huge hepatocellular carcinoma with diameter over ten centimeters: a large cohort study. Med Oncol. 2015 Mar;32(3):64. doi: 10.1007/s12032-015-0504-3. Epub 2015 Feb 15.

Reference Type: BACKGROUND

PMID: 25682389 (View on PubMed)

Huang YH, Wu JC, Chen SC, Chen CH, Chiang JH, Huo TI, Lee PC, Chang FY, Lee SD. Survival benefit of transcatheter arterial chemoembolization in patients with hepatocellular carcinoma larger than 10 cm in diameter. Aliment Pharmacol Ther. 2006 Jan 1;23(1):129-35. doi: 10.1111/j.1365-2036.2006.02704.x.

Reference Type: BACKGROUND

PMID: 16393290 (View on PubMed)

Poon RT, Ngan H, Lo CM, Liu CL, Fan ST, Wong J. Transarterial chemoembolization for inoperable hepatocellular carcinoma and postresection intrahepatic recurrence. J Surg Oncol. 2000 Feb;73(2):109-14. doi: 10.1002/(sici)1096-9098(200002)73:23.0.co;2-j.

Reference Type: BACKGROUND

PMID: 10694648 (View on PubMed)

Other Identifiers

20190124R0

Identifier Type: -

Identifier Source: org_study_id