Safety and Efficacy of GSMs-TACE Combined With Surgical Resection in Treatment of Huge Hepatocellular Carcinoma (HCC) (≥10cm)

Beijing Tsinghua Chang Gung Hospital

Status: Unknown

Conditions: Huge Hepatocellular Carcinoma (HCC) (≥10cm)

Treatments: Device: GSMs-TACE; Procedure: Surgical Resection

Study type: Interventional

Funder types: Other

Identifiers

NCT04619329

20200-0-02

Details and patient eligibility

About

A Single center, Open, Randomized Controlled Trial Evaluating the Safety and Efficacy of GSMs-TACE combined with Surgical Resection in Treatment of Huge Hepatocellular Carcinoma (HCC) (≥10cm).

Enrollment: 78 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Confirmed imaging and pathological diagnosis of HCC, or diagnosed for the first time according to the guidelines for diagnosis and treatment of primary liver cancer in China (2019 edition).
2. Barcelona Clinic Liver Cancer (BCLC) stage A or B.
3. Remnant liver volume and liver function reserve are suitable for surgical resection.
4. Main lesion diameter ≥10cm.
5. Number of HCC lesions ≤5 and all located on one liver lobe.
6. Liver function Child-Pugh class A
7. ECOG Performance Status 0-1
8. Life expectancy ≥ 6 months
9. HCC is diagnosed for the first time.
10. Age 18 to 75 years
11. Able to sign and provide written informed consent.

Exclusion criteria

1. Severe active infection >grade 2 (except for Hepatitis B and C infection).
2. Liver function Child-Pugh class C.
3. BCLC stage C.
4. Patients with unresectable HCC.
5. Platelet <60×109/L.
6. Concomitant malignant tumors in other organs.
7. Patient with severe cardiac, lung or kidney disease, or severe diabetes.
8. Pregnant or breast-feeding woman.
9. Patients with severe neuropathy and unable to report therapeutic effects.
10. Patients with severe atherosclerosis.
11. Patients with AIDS.
12. Severe hemorrhage of digestive tract within the 4 weeks prior to enrolment.
13. Severe thrombogenesis or embolic event within the 6 months prior to enrolment.
14. Currently enrolled or going to enroll in any other clinical trials.
15. Subject is not suitable to participate in the study as judged by investigator (poor patient compliance，inability to follow up).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

78 participants in 2 patient groups

GSMs-TACE+ Surgical Resection Group

Experimental group

Description:

After TACE using Lobaplatin and GSMs (150-350μm, 350-560μm, 560-710μm or 710-1000μm), patients will receive surgical resection 15-30 days later, as specified per protocol.

Treatment:

Procedure: Surgical Resection

Device: GSMs-TACE

Surgical Resection Group

Active Comparator group

Description:

Patients will receive surgical resection, as specified per protocol.

Treatment:

Procedure: Surgical Resection