A Phase II Clinical Study of Multimodal Ablation Combined With Systemic Drug Therapy for Advanced Solid Tumors.
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFudan University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Colorectal 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 therapy failure).
Clinically or pathologically confirmed melanoma liver metastasis, with inoperable or intolerable liver lesions or refusal of surgical resection;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
MTT(Multimodal Tumor Thermal Therapy System)- Colorectal Cancer
Combination productMultimodal ablation combined with cadonilimab and fruquintinib
MTT(Multimodal Tumor Thermal Therapy System)- Triple-Negative Breast Cancer
Combination productMultimodal ablation combined with pucotenlimab and TPC or sacituzumab govitecan, eribulin,gemcitabine,UTD1
MTT(Multimodal Tumor Thermal Therapy System)- Melanoma
Combination productMultimodal ablation combined with pembrolizumab or toripalimab, with other specific agents determined based on the first-line treatment regimen and the melanoma subtype.
Treatment groups
95 Participants
are divided into 3 treatment groupsGroup A: AExperimental treatment 1 intervention
Group B: BExperimental treatment 1 intervention
Group C: CExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
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).
Time frame
Up to 2 years.Secondary outcomes
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).
Time frame
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).
Time frame
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.
Time frame
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.
Time frame
Up to 2 years.Sponsors and contacts
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Source ClinicalTrials.gov