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New treatment option for Triple Negative Breast Cancer Metastatic
Official title A Phase II Clinical Study of Multimodal Ablation Combined With Systemic Drug Therapy for Advanced Solid Tumors.
ClinicalTrials.gov ID: NCT06889610
What this study is testing
What is MTT(Multimodal Tumor Thermal Therapy System)- Colorectal Cancer?
MTT(Multimodal Tumor Thermal Therapy System)- Colorectal Cancer is an investigational medicine, being studied as a potential treatment for triple negative breast cancer metastatic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- i. Common eligibility criteria for all cohorts: 1\. Age between 18-80 years,gender not limited; 2. Patients with hepatic lesions amenable to...
- Colorectal Cancer： a) Clinically or pathologically confirmed colorectal cancer with liver metastases that are unresectable, or the patient is...
- Triple-negative breast cancer :
- Clinically or pathologically confirmed triple-negative breast cancer(triple-negative defined as\<1% nuclear staining for ER and PR expression and...
- Patients who have failed standard second-line drug therapy(including those who have failed PD-1 monoclonal antibody therapy, with progression within...
You likely can't join if
- i. 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...
- Patients with immunodeficiency diseases within 7 days prior to the first dose,or currently receiving systemic corticosteroid therapy(≥10mg/day...
- Symptomatic central nervous system(CNS)metastases,or other evidence indicating that the CNS metastases have not been controlled,and deemed unsuitable...
See the full eligibility criteria
Who can join
- i. Common eligibility criteria for all cohorts: 1\. Age between 18-80 years,gender not limited; 2. Patients with hepatic lesions amenable to ablation, all hepatic lesions \<5 cm in diameter; 3. Expected survival≥3...
- Colorectal Cancer： a) Clinically or pathologically confirmed colorectal cancer with liver metastases that are unresectable, or the patient is intolerant to or refuses surgery; b) Patients who have failed standard...
- Triple-negative breast cancer :
- Clinically or pathologically confirmed triple-negative breast cancer(triple-negative defined as\<1% nuclear staining for ER and PR expression and HER2 negative);
- Patients who have failed standard second-line drug therapy(including those who have failed PD-1 monoclonal antibody therapy, with progression within six months of adjuvant or neoadjuvant therapy considered as first-line...
- Melanoma :
- Clinically or pathologically confirmed melanoma liver metastasis, with inoperable or intolerable liver lesions or refusal of surgical resection;
- Patients who have failed standard first-line drug therapy.
What rules you out
- i. 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...
- 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;
- 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...
- 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...
- 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...
- Other factors that may affect patient safety or trial compliance as judged by the investigator. ii. Additional exclusion criteria for each cohort:
- Colorectal Cancer : a) 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...
- Triple-negative breast cancer : a) 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.