Suspended

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

What is being tested

methylcantharidimide tablets

Drug

Who is being recruted

Adenocarcinoma+8

+ Carcinoma

+ Digestive System Diseases

From 18 to 75 Years

+25 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 4

Interventional

Study Start: July 2019

See protocol details

Summary

Principal SponsorSuzhou Municipal Hospital

Study ContactLei Chen, MDMore contacts

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: July 20, 2019

Actual date on which the first participant was enrolled.

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.

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

NCT03996681

Principal SponsorSuzhou Municipal Hospital

Study ContactLei Chen, MDMore contacts

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

22 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AdenocarcinomaCarcinomaDigestive System DiseasesDigestive System NeoplasmsCarcinoma, HepatocellularLiver DiseasesLiver NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and Epithelial

Criteria

12 inclusion criteria required to participate

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;

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13 exclusion criteria prevent from participating

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;

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Suzhou Municipal Hospital

Suzhou, ChinaOpen Suzhou Municipal Hospital in Google Maps

SuspendedOne Study Center