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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03996681
Recruitment Status : Not yet recruiting
First Posted : June 25, 2019
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Lei Chen, Suzhou Municipal Hospital

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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: methylcantharidimide tablets Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: TACE plus methylcantharidimide tablets
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Clinical Trial of TACE Combined With Methylcantharidimide Tablets in the Treatment of Large and Unresectable Hepatocellular Carcinoma
Estimated Study Start Date : July 20, 2019
Estimated Primary Completion Date : July 20, 2020
Estimated Study Completion Date : February 1, 2021

Arm Intervention/treatment
Experimental: 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.
Drug: 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.

Other Name: GANYU




Primary Outcome Measures :
  1. Disease control rate (DCR) [ Time Frame: 18 months ]
    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.


Secondary Outcome Measures :
  1. Time to progression (TTP) [ Time Frame: 18 months ]
    TTP was defined as the time from the date of treatment to the date of first documentation of disease progression based on modified Response Evaluation Criteria in Solid Tumors (mRECIST). Disease progression 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.

  2. Overall Survival (OS) [ Time Frame: 18 months ]
    From the date of treatment until the date of death from any cause

  3. Health Related Quality of Life (HRQoL) [ Time Frame: 18 months ]
    HRQoL assessed using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) .The EORTC QLQ-C30 included 30 questions comprising 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social) and 9 symptom scales (fatigue, pain, nausea/vomiting, dyspnoea, appetite loss, insomnia, constipation, diarrhea and financial difficulties) and a single global health and quality of life status score. Most questions used a 4-point scale (1=Not at all to 4=Very much); 2 questions used a 7-point scale (1= Very poor to 7=Excellent). All domain scores were calculated as an average of item scores and transformed to 0 to 100 score range. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/quality of life (QoL) represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problem.

  4. clinical symptoms [ Time Frame: 18 months ]
    A questionnaire about the clinical symptoms, appetite,pain and sleep.

  5. Adverse Events [ Time Frame: 18 months ]
    Postoperative adverse events were graded based on CTCAE v4.03



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03996681


Contacts
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Contact: Lei Chen, MD +86-13771775313 leichensz@sina.com
Contact: Mo Zhou +86 0512-62362596 szslyyec@163.com

Locations
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China, Jiangsu
Suzhou Municipal Hospital
Suzhou, Jiangsu, China, 215008
Contact: Mo Zhou, MD    +86 0512-62362596    szslyyec@163.com   
Sponsors and Collaborators
Suzhou Municipal Hospital
Investigators
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Principal Investigator: Lei Chen, MD Suzhou Municipal Hospital
Publications:
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Responsible Party: Lei Chen, vice president of hospital, Suzhou Municipal Hospital
ClinicalTrials.gov Identifier: NCT03996681    
Other Study ID Numbers: 20190124R0
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: all individual participant data (IPD) that underlie results in a publication
Time Frame: starting 6 months after publication
Access Criteria: Case Report Form (CRF)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lei Chen, Suzhou Municipal Hospital:
Transarterial Chemoembolization
Methylcantharidimide
Large and unresectable HCC
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases