Symptoms and General Pathology

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Carcinoma, Hepatocellular

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Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

8\~12 cycles of adjuvant chemotherapy with FOLFOX were performed 4-6 weeks after radical surgery

Routine follow-up were performed instead of adjuvant chemotherapy

Adjuvant chemotherapy

Patients received just follow-up instead of adjuvant chemotherapy

Follow-up

Rong-Ping Guo, M.D.

Wei Wei, Ph.D. M.D.

Hepatocellular carcinoma (HCC) is the sixth most common malignancies worldwide and the second leading cause of cancer-related death. Surgical resection is still the main radical approach for HCC, but the recurrence rate after hepatectomy is very high, which hampers the further improvement of prognosis of HCC patients. The conventional risk factors of recurrence including: huge tumor, multiple lesions, vessels invasion and tumor rupture. Recently, the microvessels invasion (MVI) has been recognized a novel risk factor of recurrence after hepatectomy. The investigators' previous study showed that the recurrence rate is more than 50% for the patients with \>5cm solitary tumor and MVI. The MVI was confirmed as the only independent risk factor for the overall and disease-free survival of HCC patients in multiple variables analysis. It is important to reduce the recurrence and prolong the survival of patients after hepatectomy with effective adjuvant therapy. Reported at 2014 American Society of Clinical Oncology (ASCO) annual meeting, A phase III randomized, double-blind, placebo-controlled trial of adjuvant sorafenib after resection or ablation to prevent recurrence of hepatocellular carcinoma (STORM trial) failed to meet the primary endpoint-recurrence free survival (RFS). Given the inspiring result of a recent trial, which compared with single agent of doxorubicin, the oxaliplatin-containing regimens (FOLFOX) showed significant improvement in OS, objective response rate (ORR) and disease control rate (DCR) in Asian (especially China) HCC patients. Based on these rationales, the investigators design the current prospective randomized clinical trial to evaluate the effect of adjuvant chemotherapy with FOLFOX to prolong the overall survival and reduce the recurrence in HCC patients at high risk (\>5cm solitary tumor and MVI) after resection, compared to vigilant follow-up.

The patients with solitary tumor more than 5cm and microvessels invasion after radical hepatectomy were randomized to receive adjuvant FOLFOX chemotherapy （8\~12 cycles) or follow-up. The main endpoint: overall survival (OS), disease-free survival(DFS) and safety were compared between this two groups.

Adjuvant Chemotherapy With FOLFOX in HCC Patients After Resection

The Clinical Randomized Trial of Adjuvant Chemotherapy With FOLFOX in HCC Patients at High Risk After Resection

The overall survival is defined as the percentage of patients who are alive at 5 years after their enrollments of this study.

The disease-free survival is defined as the percentage of patients who are alive at 5 years without any signs or symptoms of HCC after their enrollments of this study.

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Sun Yat-sen University

Professor

Disease Attributes

Antineoplastic Agents

All Drugs and Chemicals

Chlorotrianisene

Adjuvant TACE were performed 4-6 weeks after surgery

Routine follow-up were performed instead of adjuvant TACE

1\~2 cycles TACE were performed as adjuvant therapy after radical hepatectomy

Adjuvant TACE

Patients received just follow-up to monitor the recurrence of HCC

Rong-ping GUO, M.D.

Hepatocellular carcinoma (HCC) is the sixth most common malignancies worldwide and the second leading cause of cancer-related death. Surgical resection is still the main radical approach for HCC, but the recurrence rate after hepatectomy is very high, which hampers the further improvement of prognosis of HCC patients. The conventional risk factors of recurrence including: huge tumor, multiple lesions, vessels invasion and tumor rupture. Recently, the microvessels invasion (MVI) has been recognized a novel risk factor of recurrence after hepatectomy. The investigators' previous study showed that the recurrence rate is more than 50% for the patients with \>5cm solitary tumor and MVI. The MVI was confirmed as the only independent risk factor for the overall and disease-free survival of HCC patients in multiple variables analysis. It is important to reduce the recurrence and prolong the survival of patients after hepatectomy with effective adjuvant therapy. TACE has been utilized as an adjuvant therapy after hepatectomy, but its significance is still unknown. Then, the investigators design the current prospective randomized clinical trial to evaluate the effect of adjuvant TACE to reduce the recurrence in HCC patients at high risk (\>5cm solitary tumor and MVI) after resection, compared to vigilant follow-up.

The patients with solitary tumor more than 5cm and microvessels invasion after radical hepatectomy were randomized to receive adjuvant TACE（1\~2 cycles, 4\~6 weeks) or follow-up. The main endpoint: overall survival (OS), disease-free survival(DFS), and safety were compared between this two groups.

Adjuvant TACE to Reduce the HCC Recurrence After Resection

The Clinical Randomized Trial of Adjuvant Transarterial Chemo Embolization (TACE) to Reduce the Recurrence in Hepatocellular Carcinoma (HCC) Patients at High Risk After Resection

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Adjuvant Chemotherapy With FOLFOX in HCC Patients After Resection	NCT02738697	Carcinoma, Hepa...	Adjuvant chemot... Follow-up	18 Years - 75 Years	Sun Yat-sen University
Adjuvant TACE to Reduce the HCC Recurrence After Resection	NCT02788526	Carcinoma, Hepa...	Adjuvant TACE Follow-up	18 Years - 75 Years	Sun Yat-sen University

Spots Global Cancer Trial Database for microvessels invasion