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

Recruiting now · Phase 2

Conditions studied: Triple Negative Breast Cancer Metastatic, Melanoma Metastatic, Colorectal Cancer Metastatic

In brief

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.

Key facts

Study ID

NCT06889610

Run by

Fudan University

People needed

95

Starts

2026-03-30

Expected to finish

2028-12-30

Last updated by the study team

2026-07-13

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• i. Common exclusion criteria for all cohorts:
• 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;
• Pregnant or breastfeeding women,or women of childbearing age with a positive baseline pregnancy test;
• 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;
• 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);
• Other factors that may affect patient safety or trial compliance as judged by the investigator.
• ii. Additional exclusion criteria for each cohort:
• Colorectal Cancer :
• a) Patients with uncontrolled hypertension, defined as: patients with hypertension that cannot be well-controlled with a single antihypertensive agent (SBP ≥150 mmHg or DBP ≥100 mmHg); or patients who require two or more antihypertensive medications to control blood pressure.
• b）Patients with urine dipstick proteinuria ≥2+ and a 24-hour urinary protein level >1.0 g.
• c）Patients with gastrointestinal diseases such as active gastric or duodenal ulcers, ulcerative colitis, or active bleeding from an unresected tumor; or other conditions judged by the investigator as potentially causing gastrointestinal bleeding or perforation.

Where it is running

• Fudan University Shanghai Cancer Center — Shanghai, China (enrolling)

Full record on ClinicalTrials.gov

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