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

NCT ID: NCT06307080

Last Updated: 2025-07-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-08
• Study Completion Date: 2026-12-31

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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Multi-mode thermal ablation device

Intervention Type: 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.

Intravenous anti-PD-1 and chemotherapy

Intervention Type: DRUG

intravenous anti-PD-1 and chemotherapy

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)

Group Type: ACTIVE_COMPARATOR

Intravenous anti-PD-1 and chemotherapy

Intervention Type: DRUG

intravenous anti-PD-1 and chemotherapy

Interventions

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.

Intervention Type: DEVICE

Intravenous anti-PD-1 and chemotherapy

intravenous anti-PD-1 and chemotherapy

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Jiang Long

Chief physician of hepatobiliary and pancreatic surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Long Jiang, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Locations

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Long Jiang, MD

Role: CONTACT

jiang.long@shgh.cn

18017317460

Facility Contacts

Jiang Long, MD

Role: primary

jiang.long@shgh.cn

+86 18017317460

Other Identifiers

IIT2023-064

Identifier Type: -

Identifier Source: org_study_id