To hear about similar clinical trials, please enter your email below
Trial Title:
Clinical Study of Multimodal Ablation Remodeling Immunosensitized PD-1 in the Treatment of Pancreatic Cancer With Liver Metastasis
NCT ID:
NCT06307080
Condition:
Pancreatic Cancer
Conditions: Official terms:
Neoplasm Metastasis
Pancreatic Neoplasms
Conditions: Keywords:
liver metastases
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Multi-mode thermal ablation device
Description:
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.
Arm group label:
Multi-mode thermal ablation combined with intravenous anti-PD-1 and chemotherapy
Intervention type:
Drug
Intervention name:
Intravenous anti-PD-1 and chemotherapy
Description:
intravenous anti-PD-1 and chemotherapy
Arm group label:
Intravenous anti-PD-1 and chemotherapy
Arm group label:
Multi-mode thermal ablation combined with intravenous anti-PD-1 and chemotherapy
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai General Hospital
Address:
City:
Shanghai
Zip:
200040
Country:
China
Status:
Recruiting
Contact:
Last name:
Jiang Long, MD
Phone:
+86 18017317460
Email:
jiang.long@shgh.cn
Start date:
October 8, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Agency class:
Other
Source:
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06307080
