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

NCT03996681 | Unknown Phase 4 DMC

• 1 other identifier: 20190124R0
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

Transarterial Chemoembolization; Methylcantharidimide; Large and unresectable HCC

Outcome Measures

Primary Outcomes (1)

• Disease control rate (DCR)

  DCR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), or stable disease (SD). CR was defined as disappearance of any intratumoral arterial enhancement in all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of viable (enhancement of arterial phase) target lesions taking as reference the baseline sum of the diameters of target lesions. SD was when a case does not qualify for either PR or progressive disease (PD) and was new non-target lesions. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the baseline sum of diameters of target lesions.

  18 months

Secondary Outcomes (5)

• Time to progression (TTP)

  18 months

• Overall Survival (OS)

  18 months

• Health Related Quality of Life (HRQoL)

  18 months

• clinical symptoms

  18 months

• Adverse Events

  18 months

Study Arms (1)

TACE plus methylcantharidimide tablets

EXPERIMENTAL

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

Drug: methylcantharidimide tablets

Interventions

methylcantharidimide tablets 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.

Also known as: GANYU

TACE plus methylcantharidimide tablets

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age range from 18-75 years;
• KPS≥70;
• The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL);
• Simultaneously staged as BCLC A or BCLC B based on Barcelona Clinic Liver Cancer staging system;
• Patients must have at least one tumor lesion that can be accurately measured;
• Solitary tumor with diameter ≥10cm, or multiple tumors, diameter of the largest was more than 7cm;
• Diagnosed as unresectable with consensus by the panel of liver surgery experts,
• Re commanded treated by TACE with consensus by the panel of liver multi-disciplinary treatment (MDT);
• No past history of TACE, chemotherapy or molecule-targeted treatment;
• No Cirrhosis or cirrhotic status of Child-Pugh class A only;
• 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;
• Ability to understand the protocol and to agree to sign a written informed consent document.

You may not qualify if:

• Factors that affect oral administration, such as dysphagia, chronic diarrhea and intestinal obstruction;
• Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry;
• Known of serious heart disease which can nor endure the treatment such as cardiac ventricular arrhythmias requiring anti-arrhythmic therapy;
• Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy;
• Known history of HIV;
• History of organ allograft;
• Known or suspected allergy to the investigational agents or any agent given in association with this trial;
• Evidence of bleeding diathesis;
• Any other hemorrhage/bleeding event \> CTCAE Grade 3 within 4 weeks of first dose of study drug;
• Serious non-healing wound, ulcer, or bone fracture;
• Known central nervous system tumors including metastatic brain disease;
• Poor compliance that can not comply with the course of treatment and follow up;
• Factors that the researchers consider it not appropriate to be included

Sponsors & Collaborators

• Suzhou Municipal Hospital: lead

Study Sites (1)

Suzhou Municipal Hospital

Suzhou, Jiangsu, 215008, China

Location

Related Publications (4)

• 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.

  PMID: 29061175 BACKGROUND

• 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.

  PMID: 25682389 BACKGROUND

• 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.

  PMID: 16393290 BACKGROUND

• 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.

  PMID: 10694648 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

cantharidin methylimide

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Lei Chen, MD

  Suzhou Municipal Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Chen, MD

CONTACT

+86-13771775313; leichensz@sina.com

Mo Zhou

CONTACT

+86 0512-62362596; szslyyec@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice president of hospital

Model Details: TACE plus methylcantharidimide tablets

Study Record Dates

• First Submitted: June 21, 2019
• First Posted: June 25, 2019
• Study Start: July 20, 2019
• Primary Completion: July 20, 2020
• Study Completion: February 1, 2021
• Last Updated: June 25, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: starting 6 months after publication
• Access Criteria: Case Report Form (CRF)

Locations

CN (1)