Clinical Comparative Study of Systematic Therapy Combined With MWA and Systematic Therapy for Pancreatic Cancer

Pancreatic Neoplasms Clinical Trial

Official title:

Clinical Comparative Study of Systematic Therapy Combined With Microwave Ablation and Systematic Therapy for Pancreatic Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06231160
• Other study ID #: 82171941
• Status: Not yet recruiting
• Start date: February 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2024
• Source: Chinese PLA General Hospital
• Contact: Ping Liang
• Phone: 66939530
• Email: liangping301[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Pancreatic carcinoma (PC) is the deadliest malignant tumors worldwide. Surgical resection is one of the most effective methods for the treatment of PC, but the resectable rate is less than 20% among the patients with PCs, and the recurrent and metastatic rate is more than 80% in two years after resection. Ablation has been confirmed one of the most effective methods for solid tumors by recent twenty years and proven to be a radical treatment similar to the surgical resection for the clinical applications of hepatic and renal tumors at early clinical staging in the internationally guidelines. The purpose is to explore the efficacy and safety of microwave ablation in the treatment of pancreatic cancer in combination with systematic therapy.

Description:

Pancreatic carcinoma (PC) is the deadliest malignant tumors worldwide. Surgical resection is one of the most effective methods for the treatment of PC, but the resectable rate is less than 20% among the patients with PCs, and the recurrent and metastatic rate is more than 80% in two years after resection. Furthermore, it is difficult to achieve tumoral complete responses by traditional therapies including chemotherapy, radiotherapy and transarterial embolization. Ablation has been confirmed one of the most effective methods for solid tumors by recent twenty years and proven to be a radical treatment similar to the surgical resection for the clinical applications of hepatic and renal tumors at early clinical staging in the internationally guidelines. However, the published clinical practices on the thermal ablation of PCs with large-scale cases are rare. One of the most important reasons for this originates from the extreme complexity and difficult regulation of the temperature distribution in tumors during thermal ablation because of the own characteristics of PCs, including highly invasive growth without tumoral capsules, high proportion of the interstitial fiber tissue, and the unusual blood perfusion because of extremely chaotic microvascular structures. The purpose is to explore the efficacy and safety of microwave ablation in the treatment of pancreatic cancer in combination with systematic therapy.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 185
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Inoperable pancreatic cancer
• Age from 18 to 80
• PS score from 0 to 3
• Clear pathological diagnosis

Exclusion Criteria:

• Severe coagulation dysfunction
• Individuals with severe heart, lung, liver, and kidney dysfunction
• Individuals with acute or active infectious lesions in any part of the body
• Researchers believe that there are any other factors that are not suitable for inclusion or that affect the participation of participants in the study
• Psychological health issues that hinder this experiment

Related Conditions & MeSH terms

• Ablation
• Pancreatic Neoplasms

Intervention

Procedure:
• Systematic Therapy Combined With Microwave Ablation
Patients with unresectable pancreatic cancer were included for laboratory examination, and quality of life and pain scores were recorded. The experimental group underwent microwave ablation first, followed by chemotherapy according to the guidelines; The control group received the same chemotherapy. Record the use of chemotherapy drugs and the occurrence of adverse events. Follow up will be conducted at 30 days, 90 days, and 180 days after chemotherapy to evaluate pancreatic function and quality of life.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

References & Publications (6)

Fegrachi S, Walma MS, de Vries JJJ, van Santvoort HC, Besselink MG, von Asmuth EG, van Leeuwen MS, Borel Rinkes IH, Bruijnen RC, de Hingh IH, Klaase JM, Molenaar IQ, van Hillegersberg R. Safety of radiofrequency ablation in patients with locally advanced, unresectable pancreatic cancer: A phase II study. Eur J Surg Oncol. 2019 Nov;45(11):2166-2172. doi: 10.1016/j.ejso.2019.06.008. Epub 2019 Jun 12. — View Citation

Kluger MD, Epelboym I, Schrope BA, Mahendraraj K, Hecht EM, Susman J, Weintraub JL, Chabot JA. Single-Institution Experience with Irreversible Electroporation for T4 Pancreatic Cancer: First 50 Patients. Ann Surg Oncol. 2016 May;23(5):1736-43. doi: 10.1245/s10434-015-5034-x. Epub 2015 Dec 29. — View Citation

Martin RC 2nd, Kwon D, Chalikonda S, Sellers M, Kotz E, Scoggins C, McMasters KM, Watkins K. Treatment of 200 locally advanced (stage III) pancreatic adenocarcinoma patients with irreversible electroporation: safety and efficacy. Ann Surg. 2015 Sep;262(3):486-94; discussion 492-4. doi: 10.1097/SLA.0000000000001441. — View Citation

Siegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. CA Cancer J Clin. 2023 Jan;73(1):17-48. doi: 10.3322/caac.21763. — View Citation

Vogl TJ, Panahi B, Albrecht MH, Naguib NNN, Nour-Eldin NA, Gruber-Rouh T, Thompson ZM, Basten LM. Microwave ablation of pancreatic tumors. Minim Invasive Ther Allied Technol. 2018 Feb;27(1):33-40. doi: 10.1080/13645706.2017.1420664. Epub 2017 Dec 26. — View Citation

Wang Z, Liu M, Zhang DZ, Wu SS, Hong ZX, He GB, Yang H, Xiang BD, Li X, Jiang TA, Li K, Tang Z, Huang F, Lu M, Chen JA, Lin YC, Lu X, Wu YQ, Zhang XW, Zhang YF, Cheng C, Ye HL, Wang LT, Zhong HG, Zhong JH, Wang L, Chen M, Liang FF, Chen Y, Xu YS, Yu XL, Cheng ZG, Liu FY, Han ZY, Tang WZ, Yu J, Liang P. Microwave ablation versus laparoscopic resection as first-line therapy for solitary 3-5-cm HCC. Hepatology. 2022 Jul;76(1):66-77. doi: 10.1002/hep.32323. Epub 2022 Jan 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival	Time from receiving treatment to death	30, 90, and 180 days after the end of the last chemotherapy
Secondary	Pain relief rate	Pain relief before and after treatment	30, 90, and 180 days after the end of the last chemotherapy