Pancreatic Cancer
Conditions
Keywords
liver metastases
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.
Interventions
DEVICEMulti-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.
DRUGIntravenous anti-PD-1 and chemotherapy
intravenous anti-PD-1 and chemotherapy
Sponsors
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Survival benefit | Up to 1 year after the treatment | Effect on survival benefit of pancreatic cancer patients with liver metastasis |
Other
| Measure | Time frame | Description |
|---|---|---|
| The application of medical-mechanical combination therapy mode | Up to 1 year after the treatment | To explore a new combination of drug and device therapy for hepatic metastases of pancreatic cancer. |
Countries
China
Contacts
Primary ContactLong Jiang, MD
Outcome results
None listed