Clinical Study of Multimodal Ablation Remodeling Immunosensitized PD-1 in the Treatment of Pancreatic Cancer With Liver Metastasis
Recruiting · NCT06307080 · Interventional (participants receive a specific treatment) · Lead sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
View the official record on ClinicalTrials.gov →Interventions studied
Intravenous anti-PD-1 and chemotherapyMulti-mode thermal ablation device
What this trial is about
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.
Who can take part
Age range
18 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- age 18-70 years old, gender is not limited;
- Newly diagnosed pancreatic cancer with liver metastasis confirmed by pathology or consistent with clinical diagnosis, and no metastases to organs other than the liver;
- Imaging evaluable tumors with safe access to puncture;
- The number of half liver tumors ≤3 and the size of each tumor ≤3 cm;
- ECOG PS score ≤2 points, expected survival \> 3 months.
Exclusion criteria
- Liver function Child-Pugh grade C, severe jaundice, especially obstructive jaundice;
- The liver is significantly atrophy, the tumor is too large, and the ablation range needs to reach one-third of the liver volume;
- Expected survival \< 3 months;
- serious heart, lung, liver and kidney dysfunction and coagulation dysfunction;
- 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;
- refractory ascites, pleural fluid or bad fluid;
- Pregnancy or breastfeeding;
- 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 it is running
1 location listed.
- Shanghai General Hospital - Shanghai, Shanghai Municipality, China