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

NCT06307080 | Recruiting

• 1 other identifier: IIT2023-064
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Clinical evaluation of multimodal ablation system for pancreatic cancer with hepatic metastatic malignancies.
2. 2.Construction of a combined treatment system of multimodal ablation therapy combined with immunotherapy and chemotherapy.
3. 3.Transformation and clinical application of multimodal ablation system for pancreatic cancer with hepatic metastatic malignancies.

Conditions

Pancreatic Cancer

Keywords

liver metastases

Outcome Measures

Primary Outcomes (1)

• Safety and efficacy assessment

  To evaluate the safety and efficacy of multimodal ablation therapy combined with immunotherapy

  Up to 1 year after the treatment

Secondary Outcomes (1)

• Survival benefit

  Up to 1 year after the treatment

Other Outcomes (1)

• The application of medical-mechanical combination therapy mode

  Up to 1 year after the treatment

Study Arms (2)

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

EXPERIMENTAL

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)

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

Intravenous anti-PD-1 and chemotherapy

ACTIVE COMPARATOR

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

Drug: Intravenous anti-PD-1 and chemotherapy

Interventions

Multi-mode thermal ablation device 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.

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

Intravenous anti-PD-1 and chemotherapy DRUG

intravenous anti-PD-1 and chemotherapy

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Long Jiang, MD

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Long Jiang, MD

CONTACT

18017317460; jiang.long@shgh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician of hepatobiliary and pancreatic surgery

Study Record Dates

• First Submitted: February 18, 2024
• First Posted: March 12, 2024
• Study Start: October 8, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 9, 2025

Record last verified: 2025-07

Locations

CN (1)