Clinical Study of Multi-mode Thermal Ablation for the Treatment of Pancreatic Cancer With Liver Metastasis

Pancreatic Cancer Clinical Trial

Official title:

Clinical Study of Multi-mode Thermal Ablation for the Treatment of Pancreatic Cancer With Liver Metastasis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06307080
• Other study ID #: IIT2023-064
• Status: Recruiting
• Phase: N/A
• Start date: October 8, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Long Jiang, MD
• Phone: 18017317460
• Email: jiang.long[@]shgh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Device:
• 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.

Drug:
• Intravenous anti-PD-1 and chemotherapy
intravenous anti-PD-1 and chemotherapy

Locations

Country	Name	City	State
China	Shanghai General Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The application of medical-mechanical combination therapy mode	To explore a new combination of drug and device therapy for hepatic metastases of pancreatic cancer.	Up to 1 year after the treatment
Primary	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	Survival benefit	Effect on survival benefit of pancreatic cancer patients with liver metastasis	Up to 1 year after the treatment