Safety and Efficacy of GSMs-TACE Combined With Surgical Resection in the Treatment of Hepatocellular Carcinoma (HCC) With Type III Portal Vein Tumor Thrombus (PVTT)

Hepatocellular Carcinoma (HCC) With Type III Portal Vein Tumor Thrombus (PVTT) Clinical Trial

Official title:

Safety and Efficacy of GSMs-TACE Combined With Surgical Resection in the Treatment of Hepatocellular Carcinoma (HCC) With Type III Portal Vein Tumor Thrombus (PVTT): A Single Center, Open, Randomized Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04619342
• Other study ID #: 20304-0-01
• Status: Recruiting
• Phase: N/A
• Start date: October 30, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2020
• Source: Beijing Tsinghua Chang Gung Hospital
• Contact: Yuewei Zhang
• Phone: 00861800115669
• Email: zhangyuewei1121[@]sina.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Single center, Open, Randomized Controlled Trial Evaluating the Safety and Efficacy of GSMs-TACE Combined with Surgical Resection in the Treatment of Hepatocellular Carcinoma (HCC) with Type III Portal Vein Tumor Thrombus (PVTT).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 98
• Est. completion date: December 31, 2022
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Confirmed diagnosis of HCC with PVTT involving the main portal vein, i.e. Type III PVTT according to Cheng's classification.

2. Confirmed abundant blood supply of tumor thrombus using Computed Tomography (CT) and Magnetic Resonance Imaging (MRI).

3. The tumor must be surgically resectable.

4. ECOG Performance Status 0-2.

5. Adequate liver function (Child-Pugh class A)

6. Life expectancy = 3 months

7. Previous physical ablation is allowed.

8. Age 18 to 75 years

9. Able to sign and provide written informed consent.

Exclusion Criteria:

1. Patients previously took oral molecular targeted drug or received immunotherapy.

2. Patients with arteriovenous fistula.

3. Severe active infection >grade 2 (except for Hepatitis B and C infection).

4. Concomitant malignant tumors in other organs.

5. Presence of severe cardiac, lung or kidney disease.

6. Pregnant or breast-feeding woman.

7. Patients with severe neuropathy and unable to report therapeutic effects.

8. Patients with severe atherosclerosis.

9. Patients with AIDS.

10. Severe hemorrhage of digestive tract within the 4 weeks prior to enrolment.

11. Severe thrombogenesis or embolic event within the 6 months prior to enrolment.

12. Currently enrolled or going to enroll in any other clinical trials.

13. Subject is not suitable to participate in the study as judged by investigator (poor patient compliance, inability to follow up).

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma (HCC) With Type III Portal Vein Tumor Thrombus (PVTT)
• Thrombosis

Intervention

Device:
• GSMs-TACE
TACE using epirubicin (30-40mg/m2) and gelatin sponge microspheres (150-350µm or 350-560µm)

Procedure:
• Surgical Resection
Surgical Resection of PVTT

Locations

Country	Name	City	State
China	Beijing Changgung Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tsinghua Chang Gung Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival(PFS)	PFS is defined as the time from Day 1 of treatment until the progression of a target lesion or the appearance of new lesions.	6 months
Secondary	Median Overall Survival (mOS)		2 years
Secondary	Overall Survival		3, 6, 12 and 18 months
Secondary	Adverse Events		6 months