Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Recurrence

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

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

Heart and Blood Diseases

Thrombosis

Embolism

Embolism and Thrombosis

Vascular Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Antineoplastic Agents

Hematinics

Anesthetics

Chlorotrianisene

Liver Extracts

HR was carried out under general anesthesia using a right subcostal incision with a midline extension. Intraoperative ultrasound was routinely performed. Pringle's maneuver was routinely used with a clamp/unclamp time of 10 minutes/5 minutes.Thrombectomy was performed according to the location and extent of PVTT. The en bloc technique was used for patients if the portal vein branch could be ligated with a sufficient safety margin between its root and the tip of the thrombus

TACE with chemotherapy drugs (EADM 50mg, lobaplatin 50mg, and MMC 6mg )mixed with iodized oil lipidol

hepatic resection

TACE

Min-Shan Chen, M.D. Ph.D.

min-shan chen, M.D.,Ph.D.

min-shan chen, Ph.D.,M.D.

The treatment for Hepatocellular Carcinoma (HCC) with Portal Vein Tumor Thrombosis (PVTT) is still controversial, and there is no universally agreed protocol for its treatment. Transarterial chemoembolization (TACE) has become the most popular palliative treatment for patients with unresectable HCC, and it is no longer considered as a contraindication to HCC with PVTT. Unfortunately, the long term outcomes are generally poor for HCC treated with TACE, especially for HCC with PVTT. HR remains the only therapeutic option that may still offer a chance of cure. With advances in surgical techniques, it has become feasible to remove all gross tumors, including PVTT which has extended to the main portal vein, safely by surgery. This study aimed to evaluate the safety and efficacy of HR as compared with TACE to treat patients with HCC with PVTT. The investigators also aimed to identify patient groups that might benefit more from either treatment with HR or TACE.

Hepatocellular carcinoma (HCC) is the sixth most common cancer and the third most frequent cause of cancer death worldwide. Hepatic resection (HR) is the conventional "curative" treatment for HCC. In both the European and the Unit States Proposed Guidelines for HCC, HR is recommended only for patients with preserved liver function and with a single HCC lesion. Unfortunately, because of tumor multifocality, portal vein invasion, and underlying advanced cirrhosis, only 10%-30% of HCCs are amenable to such a "curative" treatment at the time of diagnosis. Transarterial chemoembolization (TACE) has become the most popular palliative treatment for patients with unresectable HCC, and it is no longer considered as a contraindication to HCC with portal vein tumor thrombus (PVTT). Unfortunately, the long term outcomes are generally poor for HCC treated with TACE, especially for HCC with PVTT.

To improve on the results of treatment of HCC with PVTT, attempts have been made to perform HR for these patients . HCC with PVTT remains a contraindication to liver transplantation because of the high rate of tumor recurrence, and because of the severe shortage of donor organs. HR remains the only therapeutic option that may still offer a chance of cure. With advances in surgical techniques, it has become feasible to remove all gross tumors, including PVTT which has extended to the main portal vein, safely by surgery. More HCC with PVTT, which previously were considered as unresectable, have become resectable. Recent studies have even shown favorable long-term survival outcomes of HR in well-selected cases of HCC with PVTT. However, the survival outcomes of patients with HCC with PVTT treated with HR or with TACE have not been properly compared.

This study aimed to evaluate the safety and efficacy of HR as compared with TACE to treat patients with HCC with PVTT. The investigators also aimed to identify patient groups that might benefit more from either treatment with HR or TACE.

Hepatic Resection Versus Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma Complicated by Portal Vein Tumor Thrombosis

Hepatic Resection Versus Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma Complicated by Portal Vein Tumor Thrombosis.A Prospective and Randomized Clinical Trial

Cancer Center, Sun Yat-sen University

Infections

Adenoviridae Infections

Communicable Diseases

Virus Diseases

DNA Virus Infections

Anti-Infective Agents

Ethanol

Ethiodized Oil

TACE with chemothrapy drugs (E-ADM 50mg, Lobaplatin 50 mg, MMC 6mg)and followed with embolization with lipiodol or/and polyvinyl alcohol particles.

After identifying the target artery of HCC, Recombinant Human Adenovirus Type 5 Injection（15.0\*1011vp：0.5ml\*3） will be first infused through the target artery of HCC patient and followed with chemothrapy drugs (E-ADM 50mg, Lobaplatin 50 mg, MMC 6mg) and lipiodol emulsion or/and polyvinyl alcohol particles(dependent on the tumor size) Procedure: TACE (Transcatheter arterial chemoembolization)

After identifying the target artery of HCC, Recombinant Human Adenovirus Type 5 Injection（15.0\*1011vp：0.5ml\*3） will be first infused through the target artery

Recombinant Human Adenovirus Type 5 Injection

Transartery chemoembolization with chemothrapy drugs (E-ADM 50mg, Lobaplatin 50 mg, MMC 6mg)and followed with embolization with lipiodol or/and polyvinyl alcohol particles.

Transartery Chemoembolization

Ming Shi, MD

The purpose of this study is to determine if TACE plus Recombinant Human Adenovirus Type 5 Injection will improve outcome in patients with advanced hepatocellular carcinoma (HCC) not amenable to surgery or local ablative therapy.

Transarterial chemoembolization (TACE) is currently one of the mainstays of palliative treatments worldwide for patients with unresectable Hepatocellular Carcinoma(HCC).However, the long term outcomes were generally poor for HCC patients treated with TACE. Recombinant Human Adenovirus Type 5, an E1B gene deleted adenovirus, is known to have a significant antitumor activity. In addition, local injection of recombinant human adenovirus type 5 can enhance the effect of antitumor therapies (chemotherapy and radiotherapy). The hypothesis is that patients with unresectable HCC may benefit from recombinant human adenovirus type 5 in combination with TACE.

TACE Plus Recombinant Human Adenovirus for Hepatocellular Carcinoma

Phase Ⅲ Trial of Transcatheter Arterial Chemoembolization(TACE) Plus Recombinant Human Adenovirus Type 5 Injection for Unresectable Hepatocellular Carcinoma (HCC)

Number of adverse events, and number of patients who developed adverse event. Postoperative adverse events were graded based on the Common Terminology Criteria for Adverse Events ( CTCAE )

professor

Disease Attributes

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

Rare Diseases

Hepatitis A

Hepatitis

Hepatitis B

Hepatitis B, Chronic

Hepatitis, Viral, Human

Enterovirus Infections

Picornaviridae Infections

RNA Virus Infections

Blood-Borne Infections

Hepadnaviridae Infections

Hepatitis, Chronic

Chronic Disease

Chronic Graft Versus Host Disease

Clinical Research Centre

Dato' Dr. Muhammad Radzi Abu Hassan

Dato' Dr. Jayaram Menon

Dr. Raman Muthukaruppan

Mr. Nik Azim Nik Abdullah

Dr. Haniza Omar

Dr. Soek Siam Tan

Dato' Dr. Robert Ding Phooi Huat

Mr. Kok Thye Yip

Dr. Boon Phoe Ooi

More recent studies have shown that the HBV-infected population has a greater risk of development of hepatocellular carcinoma. Nevertheless, there are still a significant number of people chronically infected by HBV who do not develop the complication. Hence, there exist biological markers that could be indicator for the disease-inducing and carcinogenic potential of the virus.

The Development of Diagnostic Biomarker Panels for Hepatitis and Liver Cancer

Strategic Alliance for The Development of Diagnostic Biomarker Panels for Hepatitis and Liver Cancer

GeneNews Sdn Bhd

Ministry of Health, Malaysia

Professor Dato' Dr. Liew Choong Chin

Patients undergoing liver resection due to hepatocellular carcinoma from 2010 to 2021 in RSCM, Jakarta, an academic tertiary-level national referral hospital in Indonesia.

Resection of a part of the liver afflicted by hepatocellular carcinoma

Liver Resection

Hepatocellular carcinoma is a type of liver cancer and is one of the leading causes of global cancer death. Surgical resection of the afflicted areas of the liver is one of the treatment methods for this condition. In this retrospective research, the investigators explore the outcomes of liver resection for hepatocellular carcinoma patients undergoing liver resection from 2010 to 2021 in Cipto Mangunkusumo General Hospital, Jakarta. The main outcome is mortality and the secondary outcomes are factors predicting mortality after resection.

Study design This is a retrospective cohort study.

Treatment of Hepatocellular Carcinoma Patients in RSCM HCC patients are managed by a multidisciplinary team (MDT) consisting of hepatologists, radiologists, pathologists, radiation oncologists, surgeons, and other specialists related to the patient's condition. Confirmed HCC patients are discussed in a weekly MDT team meeting. The meeting assigned patients to treatment options according to the Barcelona Clinic Liver Center (BCLC) staging system, patient preference, and other clinical considerations. Resection is considered for patients at very early (BCLC 0) or early (BCLC A) HCC stages. This includes CP class A patients with a single tumor or less than three small (\<3 cm) tumors. Patients assigned to surgical resection underwent either laparoscopic or open surgery. One to four segments of the liver were removed. Tissue samples were taken for further pathologic examination.

Ethical Clearance The ethics committee of The Faculty of Medicine, University of Indonesia, approved this study by giving an ethical clearance with protocol number 19-11-1313. Informed consent was taken from all patients.

Surgical Resection for Hepatocellular Carcinoma

Surgical Resection for Hepatocellular Carcinoma: a Single-Center's One Decade of Experience

Raw data without the patients' identification in the form of an Excel sheet will be made available per private request via e-mail correspondence.

Divided into hepatitis B, hepatitis C, and non-hepatitis in accordance with the laboratory results.

Divided into Chilld-Pugh A,B, and C using clinical (presence of encephalopathy or ascites) and laboratory (prothrombin time, albumin, and bilirubin levels) data.

Divided into Stages 0 and A to D using performance status, child-pugh classification, number and size (in cm) of the tumor.

Divided into single and multiple tumors according to imaging findings

Presence of cirrhosis in histopathological findings

Histopathological grading divided into 1 to 4

Histopathological grading divided well, moderate, moderate to poor, and poor

Measured in days from admission to discharge

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Adjuvant Chemotherapy With FOLFOX in HCC Patients After Resection	NCT02738697	Carcinoma, Hepa...	Adjuvant chemot... Follow-up	18 Years - 75 Years	Sun Yat-sen University
Hepatic Resection Versus Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma Complicated by Portal Vein Tumor Thrombosis	NCT01350206	Hepatocellular ...	hepatic resecti... TACE	18 Years - 75 Years	Sun Yat-sen University
TACE Plus Recombinant Human Adenovirus for Hepatocellular Carcinoma	NCT01869088	Hepatocellular ...	Recombinant Hum... Transartery Che...	18 Years - 70 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
The Development of Diagnostic Biomarker Panels for Hepatitis and Liver Cancer	NCT01310062	Hepatitis B,Chr... Carcinoma,Hepat...		21 Years -	Ministry of Health, Malaysia
The Development of Diagnostic Biomarker Panels for Hepatitis and Liver Cancer	NCT01310062	Hepatitis B,Chr... Carcinoma,Hepat...		21 Years -	Ministry of Health, Malaysia
Hepatic Resection Versus Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma Complicated by Portal Vein Tumor Thrombosis	NCT01350206	Hepatocellular ...	hepatic resecti... TACE	18 Years - 75 Years	Sun Yat-sen University
Surgical Resection for Hepatocellular Carcinoma	NCT06013657	Resectable Hepa...	Liver Resection	-	Dr Cipto Mangunkusumo General Hospital

Spots Global Cancer Trial Database for carcinoma,hepatocellular