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Hepatocellular CarcinomaPhase 4NCT03996681

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

A Phase 4 study testing methylcantharidimide tablets in people with Hepatocellular Carcinoma, run by Suzhou Municipal Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
methylcantharidimide tablets
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteChina
Study dates
20 Jul 2019to 1 Feb 2021
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
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  • 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

Trial locations and contacts

1 site in 1 country.

Lei Chen, MD contact

+86-13771775313

leichensz@sina.com

Mo Zhou contact

+86 0512-62362596

szslyyec@163.com

China1 site

  • Suzhou Municipal Hospital

    Suzhou, Jiangsu, 215008

    Mo Zhou, MD, +86 0512-62362596, szslyyec@163.com

Other trials in China

About this study

Official title: A Prospective Clinical Trial of TACE Combined With Methylcantharidimide Tablets in the Treatment of Large and Unresectable Hepatocellular Carcinoma

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.

Read the 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.

Being tested
methylcantharidimide tablets
Keywords
Transarterial Chemoembolization, Methylcantharidimide, Large and unresectable HCC
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • methylcantharidimide tabletsDrug

    Also called GANYU

    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.

Study groups in NCT03996681
Study groupRoleWhat they receive
TACE plus methylcantharidimide tabletsExperimentalMethylcantharidimide tablets( 75mg po tid) is administered before first TACE 3 days and taken continuously after TACE treatment. Every 6 weeks is a cycle.
Receives: Drug: methylcantharidimide tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 18 months

Secondary outcomes (5)

  1. Time to progression (TTP)

    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.

    Measured: 18 months

  2. Overall Survival (OS)

    From the date of treatment until the date of death from any cause

    Measured: 18 months

  3. Health Related Quality of Life (HRQoL)

    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.

    Measured: 18 months

  4. clinical symptoms

    A questionnaire about the clinical symptoms, appetite，pain and sleep.

    Measured: 18 months

  5. Adverse Events

    Postoperative adverse events were graded based on CTCAE v4.03

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2019
  2. Study start20 Jul 2019 (estimated)
  3. Primary completion20 Jul 2020 (estimated)
  4. Study completion1 Feb 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
TACE plus methylcantharidimide tablets
Masking
None (open label)
Enrolment
22 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03996681
Sponsor's protocol ID
20190124R0
Status last verified
Jun 2019
First submitted
21 Jun 2019
Last updated
25 Jun 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: all individual participant data (IPD) that underlie results in a publication

Publications

  • 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.

    PubMed 29061175

  • 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.

    PubMed 25682389

  • 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.

    PubMed 16393290

  • 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.

    PubMed 10694648

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing methylcantharidimide tablets in people with Hepatocellular Carcinoma, run by Suzhou Municipal Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lei Chen, MD (+86-13771775313, leichensz@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease control rate (DCR) (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03996681, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2019.

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