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NCT Number: NCT06307080

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

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.

Recruiting

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200040, China

Location status: Recruiting

Location contact

Jiang Long, MD

CONTACT

[email protected]

+86 18017317460

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Intravenous anti-PD-1 and chemotherapy

Drug

intravenous anti-PD-1 and chemotherapy

Primary outcomes

  1. 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

  1. Survival benefit

    Time frame: Up to 1 year after the treatment

    Effect on survival benefit of pancreatic cancer patients with liver metastasis

Other outcomes

  1. The application of medical-mechanical combination therapy mode

    Time frame: Up to 1 year after the treatment

    To explore a new combination of drug and device therapy for hepatic metastases of pancreatic cancer.

Study contacts

Contact information is provided by the study sponsor or research team.

Long Jiang, MD

CONTACT

[email protected]

18017317460

Sponsors and collaborators

Lead sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Mar 12, 2024
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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