STOPPER CHINA:With Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma

Varian

Status: Completed

Conditions: Localized Hepatocellular Carcinoma

Treatments: Device: Tandem Microsphere loaded with Epirubicin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03113955

S2382

Details and patient eligibility

About

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

Full 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).

Enrollment: 109 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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109 participants in 1 patient group

single -arm

Experimental group

Description:

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

Treatment:

Device: Tandem Microsphere loaded with Epirubicin