Colorectal Cancer Metastatic, Melanoma Metastatic, Triple Negative Breast Cancer Metastatic
Conditions
Brief 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. 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.
Interventions
COMBINATION_PRODUCTMTT(Multimodal Tumor Thermal Therapy System)- Colorectal Cancer
Multimodal ablation combined with cadonilimab and fruquintinib
COMBINATION_PRODUCTMTT(Multimodal Tumor Thermal Therapy System)- Triple-Negative Breast Cancer
Multimodal ablation combined with pucotenlimab and TPC or sacituzumab govitecan, eribulin,gemcitabine,UTD1
COMBINATION_PRODUCTMTT(Multimodal Tumor Thermal Therapy System)- Melanoma
Multimodal ablation combined with pembrolizumab or toripalimab, with other specific agents determined based on the first-line treatment regimen and the melanoma subtype.
Sponsors
Fudan University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
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 months; 4. ECOG performance status score of 0-1; 5. Within 14 days before the first dose,laboratory tests indicate adequate organ function: a) Hematology:WBC≥3.0×10\^9/L;ANC≥1.5×10\^9/L;PLT≥75×10\^9/L;HGB≥90 g/L b) Liver function:Child-Pugh score≤7,AST≤5.0×ULN;ALT≤5.0×ULN;TBIL≤1.5×ULN c) Renal function:Cr≤1.5×ULN or CrCl≥60 mL/min d) Coagulation function:INR≤1.5×ULN(for patients on anticoagulant therapy,≤3×ULN,anticoagulants must be discontinued one week before ablation);APTT≤1.5×ULN ii. Additional eligibility criteria for each cohort: 1. 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 second-line drug therapy. 2. Triple-negative breast cancer : 1. Clinically or pathologically confirmed triple-negative breast cancer(triple-negative defined as\<1% nuclear staining for ER and PR expression and HER2 negative); 2. 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 therapy failure). 3. Melanoma : 1. Clinically or pathologically confirmed melanoma liver metastasis, with inoperable or intolerable liver lesions or refusal of surgical resection; 2. Patients who have failed standard first-line drug therapy.
Exclusion criteria
i. Common
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate | Up to 2 years. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Control Rate | Up to 2 years. | 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). |
| Duration of Response | Up to 2 years. | 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). |
| Progression-Free Survival | Up to 2 years. | 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. |
| Overall Survival | Up to 2 years. | Overall Survival(OS) refers to the time from the date of enrollment to the date of death due to any cause. |
| Safety and Tolerability | Up to 2 years. | 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. |
Countries
China
Contacts
CONTACTHongxia Wang, MD
CONTACTWentao Li, MD
PRINCIPAL_INVESTIGATORHongxia Wang, MD
Fudan University
Outcome results
None listed