The Efficacy of Hepatectomy or TILA-TACE in Patients With Resectable Hepatocellular Carcinoma

HCC Clinical Trial

Official title:

A Randomized Controlled Trial of the Efficacy of Hepatectomy or TILA-TACE in Patients With Resectable Hepatocellular Carcinoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03314532
• Other study ID #: SAHZhejiangU-2017-071
• Status: Not yet recruiting
• Phase: N/A
• First received: October 8, 2017
• Last updated: October 15, 2017
• Start date: November 1, 2017
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2017
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Yun Jin, MD
• Phone: 86-1358140070
• Email: william99[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hepatocellular carcinoma (HCC) is one of the most common cancers in the world with major occurrences in eastern Asian countries such as China. HCC is the third leading cause of cancer-related deaths in the world. There are multiple treatment options for liver cancer including surgery, transcatheter arterial chemoembolization (TACE), liver transplantation, absolute ethanol injection, radiation therapy, and biological therapy. Surgery is the primary radical treatment measure for HCC, but its indication is narrow and is only suitable for certain group of patients. Another common treatment for liver cancer, TACE, can not only block tumor blood supply, control tumor growth, or even cause necrosis and result in tumor shrinkage, it can also deliver target chemotherapy drugs to the tumor tissue. However, there are still some controversies on the efficacy of TACE treatment. Therefore in this study, we will conduct a randomized comparison study of the efficacy of surgical resection and TILA-TACE treatment.

Description:

The Barcelona Clinic Liver Cancer staging system (BCLC) is one of the more recognized staging criteria and has been recommended by the European Association for the Study of Liver and the American Association for the Study of Liver Diseases. BCLC staging is based on patients' general condition, tumor condition, and liver function to identify the best treatment option and predict prognosis using evidence-based medicine. Surgical excision is recommended for BCLC stage 0, liver transplantation or radiofrequency ablation is recommended for BCLC stage A, and TACE treatment is recommended for BCLC stage B.

However, there are still some controversies on the efficacy of TACE treatment. In recent years, development of technologies has led to improved methods including targeting-intratumoral-lactic-acidosis TACE (TILA-TACE). Early clinical practice has confirmed that compared with TACE, TILA-TACE has a relatively high response rate and efficiency. In clinical practice, the current standard treatments for patients with surgically resectable HCC are controversial and there is no recommendation in the guidelines.

This study is designed to evaluate and compare the therapeutic efficacies of surgical resection and TILA-TACE treatment in patients with resectable HCC.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 230
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Ages 18-75 with no gender, ethnicity, religion, or geographical restrictions.

2. Diagnosed HCC patient.

3. The following criteria will be used for the evaluation of tumor resectability and adequate remaining liver volume: = 30% remaining liver volume/total liver volume for non-hepatitis patients; = 40% remaining liver volume/total liver volume for hepatitis patients.

4. Imaging examination with no cancer embolus above the secondary branch of the portal vein.

5. New lesions found five years after liver cancer treatment.

6. Child-Pugh A or B grade liver function.

7. No concurrent malignancies in other systems.

8. Informed subjects who fully understand and willingly cooperate with the test program with signed relevant documents.

Exclusion Criteria:

1. Suffer from other malignancies.

2. Have received any other liver cancer treatments.

3. Pathological diagnosis as non-HCC.

4. Experience large blood vessel invasion, distant metastases, or unresectable liver cancer.

5. One or more organ failures.

6. Child-Pugh C grade liver function.

7. Incomplete surgical resection or TILA-TACE.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• HCC
• Surgical Resection

Intervention

Procedure:
• TILA-TACE
After femoral artery catheterization, 5-Fr angiography catheters will be used for complete radiography of the celiac artery, the hepatic artery proper, left and right hepatic arteries and their branches, and 2.8-Fr micro-catheters will be used for complete radiography of the tumor's nutrient arteries. Lipiodol-epirubicin emulsions and 5% sodium bicarbonate injection solutions will be used for perfusion of chemotherapy drugs. Different sizes of embolic microspheres will be used alternatively for chemoembolization.

Locations

Country	Name	City	State
China	The Second Affiliated Hospital Zhejiang University School of Medicine	Hanzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

References & Publications (4)

Chao M, Wu H, Jin K, Li B, Wu J, Zhang G, Yang G, Hu X. A nonrandomized cohort and a randomized study of local control of large hepatocarcinoma by targeting intratumoral lactic acidosis. Elife. 2016 Aug 2;5. pii: e15691. doi: 10.7554/eLife.15691. — View Citation

European Association For The Study Of The Liver; European Organisation For Research And Treatment Of Cancer. EASL-EORTC clinical practice guidelines: management of hepatocellular carcinoma. J Hepatol. 2012 Apr;56(4):908-43. doi: 10.1016/j.jhep.2011.12.001 — View Citation

Sastre J, Díaz-Beveridge R, García-Foncillas J, Guardeño R, López C, Pazo R, Rodriguez-Salas N, Salgado M, Salud A, Feliu J. Clinical guideline SEOM: hepatocellular carcinoma. Clin Transl Oncol. 2015 Dec;17(12):988-95. doi: 10.1007/s12094-015-1451-3. Epub — View Citation

Zhou WP, Lai EC, Li AJ, Fu SY, Zhou JP, Pan ZY, Lau WY, Wu MC. A prospective, randomized, controlled trial of preoperative transarterial chemoembolization for resectable large hepatocellular carcinoma. Ann Surg. 2009 Feb;249(2):195-202. doi: 10.1097/SLA.0 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease-progression-free period	This will be the time period from the beginning of treatment to the time that disease progression has been observed.	This will be the time period from the beginning of treatment to the time that disease progression has been observed (up to 120 months).
Secondary	overall survival period	from the beginning of the treatment, the follow-up, until the death of the patient or the end of the study period, as well as the 1-year, 3-year, and 5-year survival rates.	from the beginning of the treatment, until the death of the patient or the end of the study period (up to 100 months).