Hepatocellular Carcinoma Clinical Trial
— NWOfficial title:
A Single-Arm, Prospective, Multicenter Study to Evaluate the Safety and Effectiveness of the NeuWave Certus Microwave Ablation System in Chinese Patients With Hepatocellular Carcinoma
Verified date | March 2024 |
Source | Ethicon, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a single-arm, prospective, multicenter, study. Individuals who are assessed for microwave (MW) ablation of HCC in accordance with their institution's standard of care (SOC), who meet study entry criteria and sign the informed consent, will be enrolled. The patients will be treated with MW ablation and afterwards followed for up to 36 months after the original ablation procedure to assess efficacy and safety. In addition to the final analysis after all enrolled patients complete the 36-month observation period, a summary of selected endpoints will be provided after all enrolled patients have completed each of the 1-month and 12-month visits. To provide sites with an opportunity to get equal experience in the use of the Certus system, there will 3 patients treated as part of a run-in phase. These patients will only be included in the safety set.
Status | Completed |
Enrollment | 135 |
Est. completion date | January 17, 2024 |
Est. primary completion date | January 17, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Diagnosed primary or recurrent HCC determined in accordance with the institution's SOC procedure, a single tumor size up to 5 cm or a maximum of 3 tumors up to 3 cm per tumor. Tumor size must be measured with at least 2-dimensional (2D) imaging. - Scheduled for microwave ablation of the liver. - Performance status 0-2 (Eastern Cooperative Oncology Group classification). - Functional hepatic reserve based on the Child-Pugh score (Class A or B). - Give voluntary, written informed consent to participate in this study and willing to comply with study-related evaluation and procedure schedule. - At least 18 years of age. Exclusion Criteria: 1. ASA score = 4. 2. Active bacterial or fungal infections which are clinically significantly. 3. Chemotherapy or radiation therapy for HCC performed within 30 days prior to the study procedure. 4. Patient with implantable pacemakers or other electronic implants. 5. Planned/ scheduled liver surgery. 6. Platelet count = 50 × 109/L. 7. Patients with uncorrectable coagulopathy at time of screening based on investigator judgement. Severe blood coagulation dysfunction (bleeding tendency, prothrombin time [PT] was greater than normal control for 3~5 seconds, platelet count [PLT] was less than 50x109/L, and the international normalized ratio [INR] was greater than 1.5). 8. Patient with renal failure and on renal dialysis. 9. Scheduled concurrent procedure other than MW ablation in the liver. 10. Pregnant or breast feeding. 11. Physical or psychological condition which would impair study participation. 12. Participation in any other interventional clinical study within 1 month before screening and concurrently during the study. 13. The patient is judged unsuitable for study participation by the investigator for any other reason. |
Country | Name | City | State |
---|---|---|---|
China | Chinese PLA General Hospital | Beijing | |
China | Sun Yat-sen University Cancer Center | Guangzhou | Guangdong |
China | The First Affiliated Hospital,Sun Yat-sen University | Guangzhou | Guangdong |
China | Renji Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Ethicon, Inc. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Safety Endpoint | Adverse events (AEs) and serious adverse events (SAEs) reported at each analysis and cumulatively throughout the entire study period. | 1,3,6,9,12,18,24,30,36 months | |
Other | Numeric Pain Rating Scale | The Numeric Pain Rating Scale (NPRS) is a patient-reported outcome. Patients will complete this scale before the ablation procedure (measured at the Screening Visit), post ablation (within 7 days after ablation), and at the 1-month follow-up visit.
This scale ranges from 0 (no pain) to 10 (worst possible pain). |
7 days/1 month(±7days) | |
Other | EORTC QLQ-C30 Questionnaire | EORTC QLQ-C30 is a patient-reported questionnaire that assesses the health-related quality-of-life (QOL) of cancer patients. This questionnaire is assessed before the ablation procedure (measured at Screening Visit), post ablation (within 7 days after ablation), and at each follow-up visit.
The questionnaire individual questions range in scores from 0 to 100 with a higher score correlating to a better quality of life for the patient for 'function' questions but correlates to worse symptoms for 'symptom' questions. |
7days/1,3,6,9,12,18,24,30,36 months | |
Other | EORTC QLQ-HCC18 Questionnaire | EORTC QLQ-HCC18 is a patient-reported questionnaire that assesses the health-related quality-of-life (QOL) of hepatocellular cancer patients. This questionnaire is assessed before the ablation procedure (measured at Screening Visit), post ablation (within 7 days after ablation), and at each follow-up visit.
All individual questions are scored from 0 to 100 with a higher score correlating with a more severe symptom or problem. |
7days/1,3,6,9,12,18,24,30,36 months | |
Primary | Primary Technical Efficacy | defined as a combination of A0 ablations (complete tumor ablation with a surrounding 5 mm margin) and A1 ablations (complete tumor ablation with inadequate margins), based on contrast-enhanced MRI scans at 1 month (+/- 7 days) after the original ablation procedure. | 1 month (+/- 7 days) | |
Secondary | Technical Success | defined as a combination of A0 ablations (complete tumor ablation with a surrounding 5 mm margin) and A1 ablations (complete tumor ablation with inadequate margins) based on contrast-enhanced Magnetic Resonance Imaging (MRI) performed up to 7 days following the original ablation procedure. | 7 days | |
Secondary | Progression-Free Survival | defined as length of time from the original ablation procedure until any type of disease progression (i.e. local or distant). | 1,3,6,9,12,18,24,30,36 months | |
Secondary | Secondary efficacy rate | defined as the percentage of tumors that have undergone successful repeat ablation following identification of local tumor progression at any time during study follow up. | 1,3,6,9,12,18,24,30,36 months | |
Secondary | Overall-survival, | measured from the time of the original ablation procedure to the time of death or last follow-up, if death has not occurred. | 1,3,6,9,12,18,24,30,36 months | |
Secondary | Local tumor progression (LTP) | evaluated at every visit after the ablation of the target tumor. LTP describes the appearance of tumor foci at the edge of the ablation zone, after at least one contrast-enhanced follow-up MRI scan has documented adequate ablation and an absence of viable tissue in the target tumor and surrounding ablation margin by using imaging criteria. | 1,3,6,9,12,18,24,30,36 months |
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