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

Not Applicable

Not yet recruiting

• Conditions: Triple Negative Breast Cancer Metastatic; Melanoma Metastatic

• Registration Number: NCT06889610
• Lead Sponsor: Fudan University

Brief Summary

This study focuses on the treatment of liver metastases from two common cancers: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-17
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-19
• Last Update Submitted: 2025-03-19
• Study First Posted: 2025-03-21
• Last Update Posted: 2025-03-21
• Study Start: 2025-04-28
• Primary Completion: 2026-07-01
• Study Completion: 2028-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

Not provided

Exclusion Criteria

i. Common exclusion criteria for all two cohorts:

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;
11. Insufficiency or failure of major organs;
12. 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;
13. Patients who have received immunotherapy and experienced grade 3 or higher immune-related adverse events(irAEs)(except for thyroid function abnormalities,blood sugar abnormalities);
14. Active or uncontrolled severe infections(≥CTCAE grade 2 infections);
15. 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;
16. Pregnant or breastfeeding women,or women of childbearing age with a positive baseline pregnancy test;
17. Known human immunodeficiency virus(HIV)infection;known clinically significant liver disease history,including viral hepatitis[known carriers of hepatitis B virus(HBV)must exclude active HBV infection,i.e.,HBV DNA positive(>1×10^4 copies/mL or>2000 IU/mL);known hepatitis C virus(HCV)infection and HCV RNA positive(>1×10^3 copies/mL),or other hepatitis,cirrhosis;
18. Patients with severe heart,lung,liver,or kidney dysfunction,irreversible coagulation disorders,or other uncontrolled diseases(including hypertension or diabetes,active infections,mental illness,or social conditions that may affect patient compliance);
19. Other factors that may affect patient safety or trial compliance as judged by the investigator.

ii. Additional exclusion criteria for each cohort:

1. Triple-negative breast cancer :

   a) Patients who have previously received Pucotenlimab treatment;

2. Melanoma :

   1. Patients who have previously received Pucotenlimab treatment;
   2. Patients currently have uncontrolled hypertension,defined as:patients with hypertension that cannot be well controlled with monotherapy(systolic blood pressure≥150 mmHg,or diastolic blood pressure≥100 mmHg);or patients using two or more antihypertensive drugs to control blood pressure;
   3. Urine routine indicates proteinuria≥2+,and 24-hour urine protein>1.0g;
   4. Significant clinically meaningful cardiovascular diseases,including but not limited to acute myocardial infarction,severe/unstable angina,or coronary artery bypass grafting within 6 months before enrollment;
   5. Congestive heart failure New York Heart Association(NYHA)classification>2;ventricular arrhythmias requiring drug treatment;electrocardiogram(ECG)showing QTc interval≥480 milliseconds.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, China