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
Qualifiers
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
Treatments tested in this trial
- 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
Treatment groups
95 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov