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

NCT06889610 | Recruiting Phase 2

• 1 other identifier: MTTP1-DHF-610
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

Triple Negative Breast Cancer Metastatic; Melanoma Metastatic; Colorectal Cancer Metastatic

Outcome Measures

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).

  Up to 2 years.

Secondary Outcomes (5)

• Disease Control Rate

  Up to 2 years.

• Duration of Response

  Up to 2 years.

• Progression-Free Survival

  Up to 2 years.

• Overall Survival

  Up to 2 years.

• Safety and Tolerability

  Up to 2 years.

Study Arms (3)

A

EXPERIMENTAL

Colorectal Cancer Cohort

Combination Product: MTT(Multimodal Tumor Thermal Therapy System)- Colorectal Cancer

B

EXPERIMENTAL

Triple-Negative Breast Cancer Cohort

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

C

EXPERIMENTAL

Melanoma Cohort

Combination Product: MTT(Multimodal Tumor Thermal Therapy System)- Melanoma

Interventions

MTT(Multimodal Tumor Thermal Therapy System)- Colorectal Cancer COMBINATION_PRODUCT

Multimodal ablation combined with cadonilimab and fruquintinib

A

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

Multimodal ablation combined with pucotenlimab and TPC or sacituzumab govitecan, eribulin,gemcitabine,UTD1

B

MTT(Multimodal Tumor Thermal Therapy System)- Melanoma COMBINATION_PRODUCT

Multimodal ablation combined with pucotenlimab, with other specific agents determined based on the first-line treatment regimen and the melanoma subtype.

C

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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:
• 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.
• 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 therapy failure).
• 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.

You may not qualify if:

• 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;
• 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 patient unsuitable for the study drug,or may affect the interpretation of the study results,or may place the patient at high risk;

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Hongxia Wang, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongxia Wang, MD

CONTACT

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

Wentao Li, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: March 21, 2025
• Study Start: November 4, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2028
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)