Clinical Study of Multimodal Ablation Remodeling Immunosensitized PD-1 in the Treatment of Pancreatic Cancer With Liver Metastasis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Safety and efficacy assessment
Study Overview
Brief Summary
- Clinical evaluation of multimodal ablation system for pancreatic cancer with hepatic metastatic malignancies.
- Construction of a combined treatment system of multimodal ablation therapy combined with immunotherapy and chemotherapy.
- Transformation and clinical application of multimodal ablation system for pancreatic cancer with hepatic metastatic malignancies.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Multi-mode thermal ablation combined with intravenous anti-PD-1 and chemotherapy
Multimodal ablation therapy +PD-1 antibody combined with intravenous chemotherapy was performed (carreilizumab 200 mg IV D1+ gemcitabine 1000mg/㎡ IV+ albumin binding paclitaxel 125mg/㎡ IV D1.8Q3W; For 6 weeks)
Intervention: Multi-mode thermal ablation device (Device)
Multi-mode thermal ablation combined with intravenous anti-PD-1 and chemotherapy
Multimodal ablation therapy +PD-1 antibody combined with intravenous chemotherapy was performed (carreilizumab 200 mg IV D1+ gemcitabine 1000mg/㎡ IV+ albumin binding paclitaxel 125mg/㎡ IV D1.8Q3W; For 6 weeks)
Intervention: Intravenous anti-PD-1 and chemotherapy (Drug)
Intravenous anti-PD-1 and chemotherapy
Intravenous chemotherapy was performed (carreilizumab 200 mg IV D1+ gemcitabine 1000mg/㎡ IV+ albumin binding paclitaxel 125mg/㎡ IV D1.8Q3W; For 6 weeks)
Intervention: Intravenous anti-PD-1 and chemotherapy (Drug)
Outcomes
Primary Outcomes
Safety and efficacy assessment
Time Frame: Up to 1 year after the treatment
To evaluate the safety and efficacy of multimodal ablation therapy combined with immunotherapy
Secondary Outcomes
- Survival benefit(Up to 1 year after the treatment)
Investigators
Jiang Long
Chief physician of hepatobiliary and pancreatic surgery
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine