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

RECRUITINGPHASE2

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

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

NCT06889610•Fudan University

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1\. Age between 18-80 years,gender not limited; 2. The number of liver metastases is≥3.Besides the ablation lesions,there must be at least one measurable lesion(≥1cm),and the diameter of the ablation lesions is\<5cm; 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

•1. Patients with known allergy or suspected allergy to the study drugs or similar drugs;
•2. Patients who have participated in another clinical study and received at least one treatment within 4 weeks prior to enrollment;
•3. 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);
•4. 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;
•5. 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;
•6. Patients who have previously undergone organ or bone marrow transplantation;
•7. Uncontrollable pleural effusion,pericardial effusion,or ascites causing respiratory syndrome(≥CTCAE grade 2 dyspnea);
•8. Esophageal(gastric fundus)variceal rupture bleeding within the last month;
•9. Other antitumor treatments outside the combined regimen,such as radiotherapy,systemic chemotherapy,etc.;
•10. Clinically significant electrolyte abnormalities as judged by the investigator;
+25 more criteria

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, China

Key Dates

Start Date

November 4, 2025

Primary Completion Date

December 30, 2027

Completion Date

December 30, 2028

Last Updated

November 21, 2025

Enrollment

ESTIMATED participants

Conditions

Triple Negative Breast Cancer MetastaticMelanoma MetastaticColorectal Cancer Metastatic

Interventions

MTT(Multimodal Tumor Thermal Therapy System)- Colorectal Cancer

COMBINATION_PRODUCT

MTT(Multimodal Tumor Thermal Therapy System)- Triple-Negative Breast Cancer

COMBINATION_PRODUCT

MTT(Multimodal Tumor Thermal Therapy System)- Melanoma

COMBINATION_PRODUCT

Contacts

Hongxia Wang, MD

CONTACT

+86 021-64175590 wanghongxia@shca.org.cn

Wentao Li, MD

CONTACT

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 21, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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