Clinical Study of Multimodal Ablation Remodeling Immunosensitized PD-1 in the Treatment of Pancreatic Cancer With Liver Metastasis

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Pancreatic Cancer

Treatments: Drug: Intravenous anti-PD-1 and chemotherapy; Device: Multi-mode thermal ablation device

Study type: Interventional

Funder types: Other

Identifiers

NCT06307080

IIT2023-064

Details and patient eligibility

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Multi-mode thermal ablation combined with intravenous anti-PD-1 and chemotherapy

Experimental group

Description:

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)

Treatment:

Device: Multi-mode thermal ablation device

Drug: Intravenous anti-PD-1 and chemotherapy

Intravenous anti-PD-1 and chemotherapy

Active Comparator group

Description:

Intravenous chemotherapy was performed (carreilizumab 200 mg IV D1+ gemcitabine 1000mg/㎡ IV+ albumin binding paclitaxel 125mg/㎡ IV D1.8Q3W; For 6 weeks)

Treatment:

Drug: Intravenous anti-PD-1 and chemotherapy