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

Not Applicable

Recruiting

• Conditions: Pancreatic Cancer
• Interventions: Device: Multi-mode thermal ablation device; Drug: Intravenous anti-PD-1 and chemotherapy

• Registration Number: NCT06307080
• Lead Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary

1. Clinical evaluation of multimodal ablation system for pancreatic cancer with hepatic metastatic malignancies.

2. Construction of a combined treatment system of multimodal ablation therapy combined with immunotherapy and chemotherapy.

3. Transformation and clinical application of multimodal ablation system for pancreatic cancer with hepatic metastatic malignancies.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-08
• Study First Submitted: 2024-02-18
• Study First Submitted QC: 2024-03-06
• Study First Posted: 2024-03-12
• Status Verified: 2024-06
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multi-mode thermal ablation combined with intravenous anti-PD-1 and chemotherapy	Intravenous anti-PD-1 and chemotherapy	Multimodal ablation therapy +PD-1 antibody combined with intravenous chemotherapy was performed (carreilizumab 200 mg IV D1+ gemcitabine 1000mg/㎡ IV+ albumin binding paclitaxel 125mg/㎡ IV D1.8Q3W; For 6 weeks)
Intravenous anti-PD-1 and chemotherapy	Intravenous anti-PD-1 and chemotherapy	Intravenous chemotherapy was performed (carreilizumab 200 mg IV D1+ gemcitabine 1000mg/㎡ IV+ albumin binding paclitaxel 125mg/㎡ IV D1.8Q3W; For 6 weeks)
Multi-mode thermal ablation combined with intravenous anti-PD-1 and chemotherapy	Multi-mode thermal ablation device	Multimodal ablation therapy +PD-1 antibody combined with intravenous chemotherapy was performed (carreilizumab 200 mg IV D1+ gemcitabine 1000mg/㎡ IV+ albumin binding paclitaxel 125mg/㎡ IV D1.8Q3W; For 6 weeks)

Primary Outcome Measures

Name	Time	Method
Safety and efficacy assessment	Up to 1 year after the treatment	To evaluate the safety and efficacy of multimodal ablation therapy combined with immunotherapy

Secondary Outcome Measures

Name	Time	Method
Survival benefit	Up to 1 year after the treatment	Effect on survival benefit of pancreatic cancer patients with liver metastasis

Trial Locations

Locations (1)

Shanghai General Hospital; 🇨🇳 Shanghai, Shanghai, China