AzTrials
AzTrials

Triple Negative Breast Cancer MetastaticPhase 2NCT06889610

A Phase II Clinical Study of Multimodal Ablation Combined With Systemic Drug Therapy for Advanced Solid Tumors.

A Phase 2 study testing MTT(Multimodal Tumor Thermal Therapy System)- Colorectal Cancer, MTT(Multimodal Tumor Thermal Therapy System)- Triple-Negative Breast Cancer and MTT(Multimodal Tumor Thermal Therapy System)- Melanoma in people with Triple Negative Breast Cancer Metastatic and Melanoma Metastatic, run by Fudan University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study focuses on the treatment of liver metastases from three common cancers: colorectal cancer, triple-negative breast cancer and melanoma. Currently, there are limitations in the treatment of liver metastases of these cancers. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
MTT(Multimodal Tumor Thermal Therapy System)- Colorectal Cancer, MTT(Multimodal Tumor Thermal Therapy System)- Triple-Negative Breast Cancer and MTT(Multimodal Tumor Thermal Therapy System)- Melanoma
Could I receive a placebo?
No, everyone receives an active treatment
How many people
95 participants
Where
1 siteChina
Study dates
30 Mar 2026to 30 Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Common exclusion criteria for all cohorts:
  • Patients with known allergy or suspected allergy to the study drugs or similar drugs;
  • Patients who have participated in another clinical study and received at least one treatment within 4 weeks prior to enrollment;
  • History or concurrent presence of other malignant tumors(except for cured basal cell carcinoma of the skin,superficial bladder cancer,carcinoma in situ of the cervix,and papillary thyroid carcinoma);
  • Patients with immunodeficiency diseases within 7 days prior to the first dose,or currently receiving systemic corticosteroid therapy(≥10mg/day prednisone or equivalent dose of other corticosteroids),or other forms of immunosuppressive therapy;
  • Symptomatic central nervous system(CNS)metastases,or other evidence indicating that the CNS metastases have not been controlled,and deemed unsuitable for enrollment by the investigator;
Show all 37Show fewer
  • Patients who have previously undergone organ or bone marrow transplantation;
  • Uncontrollable pleural effusion,pericardial effusion,or ascites causing respiratory syndrome(≥CTCAE grade 2 dyspnea);
  • Esophageal(gastric fundus)variceal rupture bleeding within the last month;
  • Other antitumor treatments outside the combined regimen,such as radiotherapy,systemic chemotherapy,etc.;
  • Clinically significant electrolyte abnormalities as judged by the investigator;
  • Insufficiency or failure of major organs;
  • Patients who have received systemic drug therapy,radiotherapy,or local liver treatment,with a time interval of less than 1 month since the last systemic treatment or local liver treatment;
  • Patients who have received immunotherapy and experienced grade 3 or higher immune-related adverse events(irAEs)(except for thyroid function abnormalities,blood sugar abnormalities);
  • Active or uncontrolled severe infections(≥CTCAE grade 2 infections);
  • Any other disease,clinically significant metabolic abnormalities,physical examination abnormalities,or laboratory test abnormalities that,in the investigator's judgment,may have a disease or condition that makes the patient unsuitable for the study drug,or may affect the interpretation of the study results,or may place the patient at high risk;
  • Pregnant or breastfeeding women,or women of childbearing age with a positive baseline pregnancy test;
  • Known human immunodeficiency virus(HIV)infection;known clinically significant liver disease history,including viral hepatitis[known carriers of hepatitis B virus(HBV)must exclude active HBV infection,i.e.,HBV DNA positive(>1×10^4 copies/mL or>2000 IU/mL);known hepatitis C virus(HCV)infection and HCV RNA positive(>1×10^3 copies/mL),or other hepatitis,cirrhosis;
  • Patients with severe heart,lung,liver,or kidney dysfunction,irreversible coagulation disorders,or other uncontrolled diseases(including hypertension or diabetes,active infections,mental illness,or social conditions that may affect patient compliance);
  • Other factors that may affect patient safety or trial compliance as judged by the investigator.
  • Additional exclusion criteria for each cohort:
  • Colorectal Cancer :
  • Patients with uncontrolled hypertension, defined as: patients with hypertension that cannot be well-controlled with a single antihypertensive agent (SBP ≥150 mmHg or DBP ≥100 mmHg); or patients who require two or more antihypertensive medications to control blood pressure.
  • b）Patients with urine dipstick proteinuria ≥2+ and a 24-hour urinary protein level >1.0 g.
  • c）Patients with gastrointestinal diseases such as active gastric or duodenal ulcers, ulcerative colitis, or active bleeding from an unresected tumor; or other conditions judged by the investigator as potentially causing gastrointestinal bleeding or perforation.
  • d）Patients with evidence or history of a significant bleeding tendency within 3 months prior to enrollment (e.g., bleeding >30 mL, hematemesis, melena, hematochezia), hemoptysis (>5 mL of fresh blood within 4 weeks), or a thromboembolic event (including stroke and/or transient ischemic attack) within the past 12 months.
  • e）Patients with clinically significant cardiovascular disease, including but not limited to, acute myocardial infarction, severe/unstable angina, or coronary artery bypass grafting within 6 months prior to enrollment.
  • f）Congestive heart failure of New York Heart Association (NYHA) class > II; ventricular arrhythmias requiring medication; or an ECG showing a QTc interval ≥480 milliseconds.
  • g）Patients who are unable to take fruquintinib orally.
  • Triple-negative breast cancer :
  • Patients who have previously received pucotenlimab treatment;
  • Melanoma :
  • Patients who have previously received pembrolizumab or toripalimab treatment;
  • Patients currently have uncontrolled hypertension,defined as:patients with hypertension that cannot be well controlled with monotherapy(systolic blood pressure≥150 mmHg,or diastolic blood pressure≥100 mmHg);or patients using two or more antihypertensive drugs to control blood pressure;
  • Urine routine indicates proteinuria≥2+,and 24-hour urine protein>1.0g;
  • Significant clinically meaningful cardiovascular diseases,including but not limited to acute myocardial infarction,severe/unstable angina,or coronary artery bypass grafting within 6 months before enrollment;
  • Congestive heart failure New York Heart Association(NYHA)classification>2;ventricular arrhythmias requiring drug treatment;electrocardiogram(ECG)showing QTc interval≥480 milliseconds.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hongxia Wang, MD contact

+86 021-64175590

wanghongxia@shca.org.cn

Wentao Li, MD contact

China1 site, 1 recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai

    Hongxia Wang, +86 021-64175590, wanghongxia@shca.org.cn

    Recruiting

Other trials in China

About this study

Official title: A Single-center,Multi-cohort,Prospective Phase II Clinical Study of Multimodal Ablation Combined With Systemic Drug Therapy for Advanced Solid Tumors.

This study focuses on the treatment of liver metastases from three common cancers: colorectal cancer, triple-negative breast cancer and melanoma. Currently, there are limitations in the treatment of liver metastases of these cancers. Multimodal thermophysical ablation therapy can reshape the tumor microenvironment, release neoantigens, and act as an in-situ vaccine. On this basis, the combination of multimodal ablation with immunotherapeutic drugs such as pucotenlimab will be explored. The efficacy and safety of this combination therapy in patients with liver metastases of solid tumors will be investigated, with the expectation of breaking through the existing treatment limitations.

Being tested
MTT(Multimodal Tumor Thermal Therapy System)- Colorectal Cancer, MTT(Multimodal Tumor Thermal Therapy System)- Triple-Negative Breast Cancer, MTT(Multimodal Tumor Thermal Therapy System)- Melanoma
Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

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

  • MTT(Multimodal Tumor Thermal Therapy System)- Colorectal CancerCombination product

    Multimodal ablation combined with cadonilimab and fruquintinib

  • MTT(Multimodal Tumor Thermal Therapy System)- Triple-Negative Breast CancerCombination product

    Multimodal ablation combined with pucotenlimab and TPC or sacituzumab govitecan, eribulin,gemcitabine,UTD1

  • MTT(Multimodal Tumor Thermal Therapy System)- MelanomaCombination product

    Multimodal ablation combined with pembrolizumab or toripalimab, with other specific agents determined based on the first-line treatment regimen and the melanoma subtype.

Study groups in NCT06889610
Study groupRoleWhat they receive
AExperimentalColorectal Cancer Cohort
Receives: Combination Product: MTT(Multimodal Tumor Thermal Therapy System)- Colorectal Cancer
BExperimentalTriple-Negative Breast Cancer Cohort
Receives: Combination Product: MTT(Multimodal Tumor Thermal Therapy System)- Triple-Negative Breast Cancer
CExperimentalMelanoma Cohort
Receives: Combination Product: MTT(Multimodal Tumor Thermal Therapy System)- Melanoma

What is being measured

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

  1. Objective Response Rate

    It refers to the proportion of patients whose tumors have reduced by a certain amount and maintained for a certain period,including cases of Complete Response(CR)and Partial Response(PR).Objective tumor responses are assessed using the Response Evaluation Criteria in Solid Tumors(RECIST 1.1).Subjects must have measurable tumor lesions at baseline,and the criteria for efficacy assessment are classified according to RECIST 1.1 as Complete Response(CR),Partial Response(PR),Stable Disease(SD),and Progressive Disease(PD).

    Measured: Up to 2 years.

Secondary outcomes (5)

  1. Disease Control Rate

    It includes the percentage of patients with confirmed cases of Complete Response(CR),Partial Response(PR),and Stable Disease(SD)out of those who are evaluable for efficacy.Subjects must have measurable tumor lesions at baseline,and the criteria for efficacy assessment are classified according to RECIST 1.1 as Complete Response(CR),Partial Response(PR),Stable Disease(SD),and Progressive Disease(PD).

    Measured: Up to 2 years.

  2. Duration of Response

    The duration of response is defined as the time interval from the start of the response(when CR or PR is first confirmed)to the time of progression or death(whichever occurs first).

    Measured: Up to 2 years.

  3. Progression-Free Survival

    It refers to the time from the date of enrollment to the date of the first recorded disease progression(PD)or death,whichever occurs first.

    Measured: Up to 2 years.

  4. Overall Survival

    Overall Survival(OS) refers to the time from the date of enrollment to the date of death due to any cause.

    Measured: Up to 2 years.

  5. Safety and Tolerability

    Safety refers to the extent to which a drug does not cause unacceptable harm or side effects when applied in the human body.Tolerability refers to the degree to which patients accept the side effects that occur after treatment,reflecting their ability to endure the side effects of the medication.All adverse events will be recorded and assessed for severity based on the NCI-CTC AE 5.0 grading criteria.During the follow-up period,all subjects will be continuously monitored,and the occurrence,duration,severity,and treatment-relatedness of adverse events will be documented.

    Measured: Up to 2 years.

Timeline

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

  1. First posted21 Mar 2025
  2. Study start30 Mar 2026
  3. Primary completion30 Dec 2027 (estimated)
  4. Study completion30 Dec 2028 (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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
95 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06889610
Sponsor's protocol ID
MTTP1-DHF-610
Status last verified
Jul 2026
First submitted
17 Feb 2025
Last updated
13 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MTT(Multimodal Tumor Thermal Therapy System)- Colorectal Cancer, MTT(Multimodal Tumor Thermal Therapy System)- Triple-Negative Breast Cancer and MTT(Multimodal Tumor Thermal Therapy System)- Melanoma in people with Triple Negative Breast Cancer Metastatic and Melanoma Metastatic, run by Fudan University 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 0 inclusion and 37 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: looking for participants now, as of the sponsor's last update on 13 Jul 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Hongxia Wang, MD (+86 021-64175590, wanghongxia@shca.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (time frame: Up to 2 years.). 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 NCT06889610.

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 13 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in