Clinical trial NCT03314532: The Efficacy of Hepatectomy or TILA-TACE in Patients With Resectable Hepatocellular Carcinoma
Official title: A Randomized Controlled Trial of the Efficacy of Hepatectomy or TILA-TACE in Patients With Resectable Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Surgical Resection
HCC
Keywords: Surgical Resection
TILA-TACE
Hepatocellular carcinoma
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2017-10-19
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled experimental design method will be adopted.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: disease-progression-free period
timeFrame: 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 outcomes:
measure: overall survival period
timeFrame: from the beginning of the treatment, until the death of the patient or the end of the study period (up to 100 months).
Other outcomes:
Locations:
city: Hanzhou
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Jiang-tao Li, MD
role: STUDY_DIRECTOR
References:
citation: Sastre J, Diaz-Beveridge R, Garcia-Foncillas J, Guardeno R, Lopez 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 2015 Nov 25.
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. No abstract available.
citation: 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:e15691. doi: 10.7554/eLife.15691.
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.0b013e3181961c16.