Clinical Study of Multimodal Ablation Remodeling Immunosensitized PD-1 in the Treatment of Pancreatic Cancer With Liver Metastasis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Multi-mode thermal ablation device, Intravenous anti-PD-1 and chemotherapy.
- Who it may be relevant to
- Registry conditions: Pancreatic Cancer. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Device 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. - Drug Intravenous anti-PD-1 and chemotherapy
intravenous anti-PD-1 and chemotherapy
Primary outcome measures
- Safety and efficacy assessment [Time frame: Up to 1 year after the treatment]
Secondary outcome measures (1)
- Survival benefit [Time frame: Up to 1 year after the treatment]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai General Hospital — Shanghai
Identifiers
NCT: NCT06307080 · IIT2023-064