Clinical trial NCT06231160: Clinical Comparative Study of Systematic Therapy Combined With MWA and Systematic Therapy for Pancreatic Cancer
Official title: Clinical Comparative Study of Systematic Therapy Combined With Microwave Ablation and Systematic Therapy for Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pancreatic Neoplasms
Ablation
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pancreatic cancer

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: overall survival
timeFrame: 30, 90, and 180 days after the end of the last chemotherapy
Secondary outcomes:
measure: Pain relief rate
timeFrame: 30, 90, and 180 days after the end of the last chemotherapy
Other outcomes:
Locations:
Study officials:
affiliation: The Fifth Medical Center of the General Hospital of the PLA of China
name: Ping Liang
role: STUDY_CHAIR
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