Clinical trial NCT03113955: STOPPER CHINA:With Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma
Official title: A Single-arm Trial of Transcatheter Arterial Chemoembolization With Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Localized Hepatocellular Carcinoma
Lead sponsor: Varian, a Siemens Healthineers Company
Sponsor class: INDUSTRY
First posted: 2017-04-14
Enrollment: 109
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
Primary purpose: TREATMENT

Brief summary: A Single-arm Trial of Transcatheter Arterial Chemoembolization with Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma

Detailed description: It is a prospective, single-arm, multicenter study. The primary effectiveness endpoint for this clinical trial is 6-month overall objective tumor response (ORR).

Eligibility criteria: Inclusion Criteria:

1. Subject is able to provide informed consent and must sign the Institutional Review Board/Ethics Committee (IRB/EC) approved Informed Consent Form.
2. Male or female of age ≥18 and ≤75 years.
3. Confirmed diagnosis of HCC according to the diagnostic criteria included in the management guideline issued by China's Ministry of Health in 2017.
4. HCC is diagnosed for the first time or recurrence of tumor after surgical or ablation treatment.
5. Single tumor less than 7cm in diameter or multiple tumors with maximum 3 lesions with \>1cm in diameter, individual diameter \<7cm and less than 10cm in total diameter.
6. no previous chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy) for HCC
7. Preserved liver function (Child-Pugh A or B7).
8. ECOG Performance Status 0 or 1.

Exclusion Criteria:

1. Presence of vascular invasion or extra-hepatic spread of disease, or diffuse HCC, defined as \>50% liver involvement , or arteriovenuous fistula
2. Macrovascular invasion of main or primary branches of portal vein at entry into the study
3. Any contraindication for TACE treatment
4. Any contraindication for Epirubicin administration
5. Advanced liver disease (bilirubin levels \>2 mg/dl, AST or ALT \>5 times upper limit of normal)
6. Renal failure or insufficient renal function (Creatinine levels \>2 mg/dl)
7. Subject unable to receive MRI examination
8. Pregnant or breast feeding woman, or plan to become pregnant during treatment or within 12 months of treatment
9. couldn't commit reliable birth control measures during treatment or within 12 months of treatment
10. Subject is participating other investigational drug or device clinical trial within 30 days of signing the informed consent
11. Subject is not suitable to participate in the study as judged by investigator

Primary outcomes:
measure: Number of Participants With Objective Tumor Response at 6 Months by MRI (Magnetic Resonance Imaging)
timeFrame: At 6 months
Secondary outcomes:
measure: Kaplan-Meier Analyses the Percent of Participants for Time to Progression (TTP) at 12 Months
timeFrame: At 12 months
measure: Number of Participants With Objective Tumor Response at 30-day
timeFrame: At 1month
measure: Kaplan-Meier Analyses the Percent of Participants for PPF(Proportion Progression-Free) at 12 Months
timeFrame: from first TACE to 12 months
measure: Kaplan-Meier Analyses the Percent of Participants for Overall Survival
timeFrame: from first TACE to 12 months
measure: Number of Adverse Events Relate to Study Device in 12 Months Post Procedure
timeFrame: in 12 months
measure: Number of Participants With Objective Tumor Response at 3 Months
timeFrame: At 3 months
measure: Kaplan-Meier Analyses the Percent of Participants for Time to Extrahepatic Spread
timeFrame: At 12 month
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
state: Beijing
city: Guangzhou
country: China
facility: Guangdong Nanfang Hospital
state: Guangdong
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Nanjing
country: China
facility: Zhongda Hospital Affiliated Southeast University
state: Jiangsu
city: Shenyang
country: China
facility: Shengjing Hospital Affiliated China Medical University
state: Liaoning
city: Shanghai
country: China
facility: Shanghai Zhongshan Hospital
state: Shanghai
city: Hangzhou
country: China
facility: Second Aff. Hosp. of Zhejiang University College of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: BSC China
name: Cathy Peng
role: STUDY_DIRECTOR
References: