Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Phase
Not applicable
Started
2023-10-08
Last updated
2025-07-09
Condition(s) studied
Pancreatic Cancer
Investigational drug(s) / intervention(s)
Multi-mode thermal ablation deviceIntravenous anti-PD-1 and chemotherapy
Multi-mode thermal ablation device: The tumor tissue was rapidly frozen until the ice ball exceeded 5mm of the lesion tissue, kept for 5 minutes, then thawed and warmed. Then, complete ablation was performed according to the radiofrequency temperature control mode of multimodal tumor therapy to ensure that the ablation area included a safe range of 5\~10mm around the tumor.
Intravenous anti-PD-1 and chemotherapy: intravenous anti-PD-1 and chemotherapy
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Safety and efficacy assessment — Up to 1 year after the treatment To evaluate the safety and efficacy of multimodal ablation therapy combined with immunotherapy
Trial sites (1)
Facility
City
Region
Status
Shanghai General Hospital
Shanghai
Shanghai Municipality
Recruiting
More Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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