Treatment of pancreatic cancer with liver metastasis using combined therapies

Clinical Study of Multimodal Ablation Remodeling Immunosensitized PD-1 in the Treatment of Pancreatic Cancer With Liver Metastasis

This study is testing a new treatment that combines heat therapy, immune therapy, and chemotherapy for people with pancreatic cancer that has spread to the liver to see if it works better than current options.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06307080 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates a multimodal ablation system designed for patients with pancreatic cancer that has spread to the liver. The approach combines thermal ablation therapy with immunotherapy using anti-PD-1 agents and chemotherapy to enhance treatment efficacy. The study aims to assess the safety and effectiveness of this combined treatment in newly diagnosed patients with specific tumor characteristics. Participants will undergo imaging evaluations to ensure safe access for the ablation procedure.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with newly diagnosed pancreatic cancer that has metastasized to the liver, with specific tumor size and number criteria.

Not a fit: Patients with severe liver dysfunction, extensive metastasis beyond the liver, or those with a poor prognosis of less than three months are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for patients with pancreatic cancer and liver metastasis.

How similar studies have performed: While multimodal approaches in cancer treatment have shown promise, this specific combination of therapies in pancreatic cancer with liver metastasis is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. age 18-70 years old, gender is not limited;
2. Newly diagnosed pancreatic cancer with liver metastasis confirmed by pathology or consistent with clinical diagnosis, and no metastases to organs other than the liver;
3. Imaging evaluable tumors with safe access to puncture;
4. The number of half liver tumors ≤3 and the size of each tumor ≤3 cm;
5. ECOG PS score ≤2 points, expected survival \> 3 months.

Exclusion Criteria:

1. Liver function Child-Pugh grade C, severe jaundice, especially obstructive jaundice;
2. The liver is significantly atrophy, the tumor is too large, and the ablation range needs to reach one-third of the liver volume;
3. Expected survival \< 3 months;
4. serious heart, lung, liver and kidney dysfunction and coagulation dysfunction;
5. Uncontrolled co-morbidities, including poorly controlled hypertension or diabetes, persistent active infections, or mental illness or social conditions that may affect participants' compliance with the study;
6. refractory ascites, pleural fluid or bad fluid;
7. Pregnancy or breastfeeding;
8. The researcher considers that there are any other factors that are not suitable for inclusion or affect the participant's participation in the study.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai General Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Long Jiang, MD — Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Study coordinator: Long Jiang, MD

Conditions Pancreatic Cancer; liver metastases