Clinical trial NCT04520906: To Evaluate the Safety and Efficacy of Microwave Ablation Therapy in Patients With Primary Liver Cancer
Official title: Prospective, Multicenter, Single-group Target Study to Evaluate the Safety and Efficacy of Microwave Ablation Therapy in Patients With Primary Liver Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatocellular Carcinoma
Lead sponsor: Suzhou Hengruihongyuan Medical Technology Co. LTD
Sponsor class: INDUSTRY
First posted: 2020-08-20
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective, multi-center, single-group target value
Primary purpose: TREATMENT

Brief summary: Through the implementation of prospective, multi-center, single-group target value research to verify the safety and effectiveness of the microwave ablation treatment system for the ablation treatment of primary liver cancer.

Detailed description: The safety and effectiveness of the microwave ablation treatment system produced by Suzhou Hengrui Hongyuan Medical Technology Co., Ltd. for the ablation treatment of primary liver cancer is verified through the implementation of prospective, multi-center, single-group target value research. According to the requirements of the trial, 139 patients who were diagnosed with primary liver cancer before surgery and met the inclusion criteria without any exclusion criteria were selected for treatment of their liver cancer with a microwave ablation treatment system, 1 month, 3 months and 6 months after surgery Carry out clinical and imaging follow-up to evaluate the safety of the operation and the effect of tumor ablation.

Eligibility criteria: Inclusion Criteria:

* Pathological and/or clinical diagnosis confirmed as primary liver cancer (hepatocellular carcinoma).
* Single tumor with maximum diameter ≤ 5cm ; or tumors number ≤ 3 with maximum diameter ≤ 3cm.
* No invasion of blood vessels, gallbladder, adjacent organs and distant metastasis.
* Child-Pugh class A or B classification, or meet the standard after treatment.
* Able to understand the content of clinical trials, voluntarily participate in the trial and sign informed consent.

Exclusion Criteria:

* Pregnant or breastfeeding, or preparing to become pregnant during the trial.
* Participating in clinical trials of other devices or drugs.
* Uncorrectable coagulation dysfunction (after corrective treatment, the PT exceeds the normal control value by more than 3s).
* PLT \<50x109/L.
* Intractable massive ascites.
* Cachexia.
* MRI examination is contraindicated or the investigator judges it is not suitable for MRI examination.
* Patients with bleeding from esophageal (fundus of stomach) varicose veins 1 month before surgery.
* Patients with impaired consciousness or unable to cooperate with treatment.
* The investigator judged that it is not suitable to participate in clinical trials.

Primary outcomes:
measure: Complete tumor ablation rate
timeFrame: 1 month after surgery
Secondary outcomes:
measure: First complete tumor ablation rate
timeFrame: 1 month after surgery
measure: Complete ablation rate of lesions
timeFrame: 1 month after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
state: Beijing
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
state: Jiangsu
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Soochow University
state: Jiangsu
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Shanghai
country: China
facility: Ruijin Hospital,Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
city: Shanghai
country: China
facility: Renji Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Lishui
country: China
facility: The Central Hospital of Lishui City
state: Zhejiang
Study officials:
affiliation: Zhongda Hospital
name: Gaojun Teng, Doctor
role: PRINCIPAL_INVESTIGATOR
References: