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New heat-activated gel could boost liver cancer therapy

NCT ID NCT07356531

Disease control Sponsor: JIANGSU SHENMING Medical Technology CO., Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new gel that hardens at body temperature to block blood flow to liver tumors during chemoembolization. About 216 adults with liver cancer will receive either the new gel or standard gelatin sponge particles. The goal is to see if the new gel better controls tumor growth.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 216 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

May 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 1\) Aged 18 to 80 (inclusive), of either gender; * 2\) Subjects who have been diagnosed with hepatocellular carcinoma (pathologically or clinically) according to the diagnostic criteria in the "Diagnosis and Treatment Guidelines for Primary Liver Cancer (2024 Edition)" and require TACE treatment; * 3\) Subjects with stage Ⅱb and Ⅲa liver cancer according to the Chinese Liver Cancer Staging Classification (CNLC), as well as subjects with stage Ⅰa, Ⅰb, and Ⅱa liver cancer who are not suitable/willing for surgical resection, liver transplantation, and ablation therapy; * 4\) Subjects with at least one untreated intrahepatic tumor lesion (maximum diameter ≤10cm) that meets the mRECIST definition (diameter ≥1cm); * 5\) The subjects agree to participate in this study and sign the informed consent form. Exclusion Criteria: * 1\) Subjects whose target lesions have undergone local treatment (including but not limited to surgery, TACE, radiotherapy, hepatic artery infusion, ablation, etc.), or subjects whose target lesions require ablation/radiotherapy in combination with TACE treatment at the time of enrollment; * 2\) Subjects whose blood routine test results meet the following criteria: white blood cell count \<3.0×10\^9/L; platelet count \<50×10\^9/L, and this condition cannot be corrected (excluding subjects with hypersplenism or chemotherapy-induced bone marrow suppression); * 3\) Renal dysfunction: serum creatinine \>176.8 μmol/L or creatinine clearance rate \< 30 ml/min; * 4\) Uncorrectable coagulation dysfunction; * 5\) Uncorrectable hypercalcemia and respiratory acidosis; * 6\) Patients with systemic cachexia or multiple organ failure; * 7\) Patients with severe infections that cannot be effectively controlled and are not suitable for TACE treatment; * 8\) Complete obstruction of the main portal vein, insufficient collateral compensation of the portal vein, and inability to restore portal venous blood flow to the liver through portal veinoplasty; * 9\) Known contraindications or allergies to anthracycline chemotherapeutic drugs, calcium chloride injection, contrast media, and embolic materials; * 10\) Patients who are currently using cardiac glycosides; * 11\) Patients with target lesions who are at risk of ectopic embolism in the feeding artery (such as vascular access endangering normal areas, uncorrectable arteriovenous fistulas, and portal vein fistulas) or anatomical abnormalities that make them unsuitable for interventional procedures; * 12\) Patients who have been diagnosed with other malignant tumors within 2 years before randomization (except for basal cell or squamous cell skin cancer, cervical or breast carcinoma in situ that have been resected radically); * 13\) Patients with diffuse or distant extensive metastasis of tumors, with an expected survival time of less than 90 days; * 14\) Pregnant/lactating women, or those who have family planning; * 15\) Subjects who have participated in other drug or medical device intervention clinical trials within 30 days before randomization; * 16\) Other subjects who were considered unsuitable for participation in this clinical trial by the researchers.

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Conditions

The condition(s) this trial relates to.

hepatocellular carcinoma liver cancer Liver Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Liver cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    15 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Affiliated Cancer Hospital of Guangxi Medical University

    RECRUITING

    Nanning, Guangxi, 530012, China

  • Anhui Provincial Hospital

    RECRUITING

    Hefei, Anhui, 230002, China

  • Anyang Tumor Hospital

    RECRUITING

    Anyang, Henan, 455001, China

  • First Affiliated Hospital of Gannan Medical University

    RECRUITING

    Ganzhou, Jiangxi, 341099, China

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, Henan, 450000, China

  • Jilin Guowen Hospital

    RECRUITING

    Gongzhuling, Jilin, 130028, China

  • Lishui Central Hospital

    RECRUITING

    Lishui, Zhejiang, 323020, China

  • Peking University First Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100034, China

  • Shanxi Bethune Hospital

    RECRUITING

    Taiyuan, Shanxi, '030032, China

  • The Affiliated Cancer Hospital of Guizhou Medical University

    RECRUITING

    Guiyang, Guizhou, 550008, China

  • The First Affiliated Hospital of Henan University of Science & Technology

    RECRUITING

    Luoyang, Henan, 471023, China

  • The First Affiliated Hospital of Wenzhou Medical University

    RECRUITING

    Wenzhou, Zhejiang, 325000, China

  • The Fourth Hospital of Hebei Medical University (Hebei Provincial Cancer Hospital)

    RECRUITING

    Shijiazhuang, Hebei, '050010, China

  • The Second Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, Jiangxi, 330008, China

  • Yichang Central People's Hospital

    RECRUITING

    Yichang, Hubei, 443008, China

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