Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Bone Density Conservation Agents

Vitamins

Oxaliplatin

Leucovorin

Fluorouracil

Levoleucovorin

Calcium

Calcium, Dietary

Folinic Acid

transarterial chemoinfusion (TAI) with mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)

no neo-adjuvant treatment before operation

transarterial chemoinfusion with mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)

Shaohua Li, MD

Rong-Ping Guo, M.D.

Wei Wei, Ph.D. M.D.

To compare the impact on survival of neo-adjuvant TAI for patients with beyond Milan criteria BCLC stage A/B HCC who underwent hepatectomy.

The Impact on Survival of Neo-adjuvant Transarterial Chemoinfusion (TAI) for Patients With Beyond Milan Criteria BCLC Stage A/B Hepatocellular Carcinoma Who Underwent Hepatectomy

The Impact on Survival of Neo-adjuvant Transarterial Chemoinfusion (TAI) for Patients With Beyond Milan Criteria BCLC Stage A/B Hepatocellular Carcinoma Who Underwent Hepatectomy: A Random, Controlled, Stage III Clinical Trial

Sun Yat-sen University

Professor

Symptoms and General Pathology

Nausea

Vomiting

Neoplasm Metastasis

Neoplastic Processes

Signs and Symptoms, Digestive

Hematinics

Cisplatin

Liver Extracts

Electro-stimulation at an active (responsive) acupuncture site on the bottom of the foot.

Electro-stimulation at a inactive site on the bottom of the foot (a "placebo" site).

Electro-Stimulation of Yongquan (K1) Acupoint

Lorenzo Cohen, PHD

Objectives:

This protocol is part of a larger grant funded by the NCI to create an international research center to study Traditional Chinese Medicine (TCM). All of the patients enrolled in this study will be treated at the Cancer Hospital, Fudan University, investigator's sister institution in Shanghai, China. No patients will be seen at MDACC. This protocol will be overseen by the Fudan University Institutional Review Board (IRB00002408) which has Federal Wide Assurance through the U.S. Department of Health \& Human Services (Approved: April 25, 2002). The research nurses have received training at MDACC and will receive regular oversight by MDACC personnel.

The purpose of this randomized, placebo controlled study is to determine the effects of K1 acustimulation at controlling chemotherapy induced nausea and vomiting (CINV).

1. The primary aim of this study is to determine the effects of electro-stimulation of Yongquan (K1) acupoint on preventing nausea and vomiting induced by cisplatin or oxaliplatin.
2. The secondary aim is to observe the effects of electro-stimulation (ES) of Yongquan (K1) acupoint on pain, insomnia, abdominal distention, dizziness, and general sense of well-being.

Nausea and vomiting are common side effects caused by chemotherapy. Some studies have shown that acupuncture can be helpful in treating nausea and vomiting. Acupuncture uses very thin needles inserted at certain points on the body that are believed to affect bodily functions. Researchers want to study the effects on nausea and vomiting of giving electro-stimulation (using wires attached to the body to provide very small electrical shocks to the skin) to an acupuncture site, compared to giving electro-stimulation to a inactive site (a site that does not respond to acupuncture).

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to be in 1 of 2 groups. Participants in one group will receive electro-stimulation at an active (responsive) acupuncture site on the bottom of the foot. Participants in the other group will receive electro-stimulation at a inactive site on the bottom of the foot (a "placebo" site).

Participants in both groups will have electro-stimulation on the feet. You will sit or lie down in bed. The acupuncturist will wet the points with a cotton ball dipped in water and attach the electrodes of the electro-stimulating instrument to the bottom of your feet. The electrodes are little paddles that will be attached with tape. The acupuncturist will begin slowly increasing the stimulation to a level you can withstand comfortably. This will last about 30 minutes.

The stimulation will occur about 1-2 hours before your TAI chemotherapy on the first day, and then between 7-9 A.M. on the next 5 days.

After each electro-stimulation procedure, your vital signs will be measured, you will complete quality-of-life questionnaires, and you will be asked about hiccups and diet tolerance (how nausea has affected your ability to eat or how much you eat). After your last electro-stimulation, you will also have a TCM diagnosis. This will include diagnosis by a doctor as well as by using a heart-rate machine and taking a photograph of your tongue. Blood (about 1 teaspoon) will also be drawn to check your liver function about 6 days after the treatments.

You will be given the standard medicines if you experience uncontrolled nausea or vomiting while on this study.

Your total participation on this study will last less than 2 weeks.

This is an investigational study. Up to 100 patients will take part in this study. All will be enrolled at the Fudan University Cancer Hospital.

Effects of Acupoint Electro-stimulation on Preventing Nausea and Vomiting Induced by Cisplatin or Oxaliplatin

Vomiting and nausea will be classified according to the WHO criteria. The four levels of nausea are defined as: 0=no nausea, 1=slight nausea, 2=obvious nausea affecting normal life, and 3-4=continual and serious nausea. The four levels of vomiting are defined as: 0=no vomiting, 1=vomiting 1-2 times/day, 2=vomiting 2-4 times/day, and 3-4=vomiting 5 times/day.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Heart and Blood Diseases

Recurrence

Thrombosis

Disease Attributes

Embolism

Embolism and Thrombosis

Vascular Diseases

Anti-Infective Agents

Epirubicin

Chlorotrianisene

Ethiodized Oil

Hormones

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Folate

Vitamin B9

transarterial chemoembolization with epidoxorubicin and cisplatin and lipiodol

TACE

epidoxorubicin and cisplatin and lipiodol

mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)

Li Shaohua, MD

To compare the impact on recurrence risk of adjuvant TAI and adjuvant TACE for patients with HCC and PVTT after hepatectomy.

The Impact on Recurrence Risk of Adjuvant Transarterial Chemoinfusion (TAI) Versus Adjuvant Transarterial Chemoembolization (TACE) for Patients With Hepatocellular Carcinoma And Portal Vein Tumor Thrombosis (PVTT) After Hepatectomy : A Random, Controlled, Stage III Clinical Trial.

Sorafenib

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Protein Kinase Inhibitors

Retreatment With Transcatheter arterial infusion of oxaliplatin , fluorouracil, and leucovorin

Retreatment with TAI: administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries

TAI of FOLFOX

Ming Shi

Transarterial chemoembolization (TACE) is considered the gold standard for treating intermediate-stage hepatocellular carcinoma (HCC). However, any treatment guidelines do not specify the criteria for repeating TACE. The study,conducted in Europe ，recently published in the journal of Hepatology shows the ART score of \>=2.5 prior the second TACE identifies patients with a dismal prognosis who may not profit from further TACE sessions. However,in clinical practice，we also found some patients who showed TACE-resistant at the beginning of treatment may access to get objective response of retreatment with transcatheter arterial infusion (TAI). So the investigators conduct this prospective,randomized controlled study to find out whether the patient who showed TACE-resistant can obtain survival benefit from retreatment with TAI.

Transarterial chemoembolization (TACE) is considered the gold standard for treating intermediate-stage hepatocellular carcinoma (HCC). However, intermediate-stage HCC includes a heterogeneous population of patients with varying tumour burdens, liver function (Child-Pugh A or B) and disease aetiology.This suggests that not all patients with intermediate-stage HCC will derive similar benefit from transcatheter arterial infusion (TAI), and that some patients may benefit from other treatment options.

Repetition of TACE is based on evidence suggesting that one cycle of TACE may not be sufficient for effective treatment of intermediate-stage HCC and repeating TACE prolongs survival. However, intermediate-stage HCC patients often have unsatisfactory clinical outcomes with repeated TACE and there is not sufficiently addressed by existing guidelines include the criteria for repeating TACE and recommendations about the number of TACE cycles to be repeated before switching to another or no treatment.The study,recently published in the journal of Hepatology shows the ART score of \>=2.5 prior the second TACE identifies patients with a dismal prognosis who may not profit from further TACE sessions.In clinical practice，however, we also found some patients who showed TACE-resistant at the beginning of treatment may access to get objective response of retreatment with TAI. So we conduct this prospective,randomized controlled study to find out whether the patient who showed TACE-resistant can obtain survival benefit from retreatment with TAI.

The Efficacy and Safety of Retreatment With TAI for Patients Who Showed TACE-resistant: a Randomized Controlled Trial

The Efficacy and Safety of Retreatment With Transcatheter Arterial Infusion (TAI) for Patients Who Showed TACE-resistant: a Randomized Controlled Trial

All severe adverse events for the entire course of treatment

Kaiping Central Hospital

Guangzhou No.12 People's Hospital

Prof.

To compare the impact on survival of neo-adjuvant TAI for patients with HCC and PVTT who underwent hepatectomy.

The Impact on Survival of Neo-adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma And Portal Vein Tumor Thrombosis (PVTT) Who Underwent Hepatectomy : A Random, Controlled, Stage III Clinical Trial.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Impact on Survival of Neo-adjuvant Transarterial Chemoinfusion (TAI) for Patients With Beyond Milan Criteria BCLC Stage A/B Hepatocellular Carcinoma Who Underwent Hepatectomy	NCT03851913	Hepatocellular ...	TAI	18 Years - 75 Years	Sun Yat-sen University
Effects of Acupoint Electro-stimulation on Preventing Nausea and Vomiting Induced by Cisplatin or Oxaliplatin	NCT00430313	Liver Cancer Liver Metastasi...	Electro-Stimula... Electro-Stimula...	18 Years - 75 Years	M.D. Anderson Cancer Center
The Impact on Recurrence Risk of Adjuvant Transarterial Chemoinfusion (TAI) Versus Adjuvant Transarterial Chemoembolization (TACE) for Patients With Hepatocellular Carcinoma And Portal Vein Tumor Thrombosis (PVTT) After Hepatectomy : A Random, Controlled, Stage III Clinical Trial.	NCT03192644	Hepatocellular ...	TAI TACE epidoxorubicin ... mFOLFOX6 (oxali...	18 Years - 75 Years	Sun Yat-sen University
The Efficacy and Safety of Retreatment With TAI for Patients Who Showed TACE-resistant: a Randomized Controlled Trial	NCT02220088	Hepatocellular ...	TAI of FOLFOX Sorafenib	18 Years - 70 Years	Sun Yat-sen University
Effects of Acupoint Electro-stimulation on Preventing Nausea and Vomiting Induced by Cisplatin or Oxaliplatin	NCT00430313	Liver Cancer Liver Metastasi...	Electro-Stimula... Electro-Stimula...	18 Years - 75 Years	M.D. Anderson Cancer Center
The Impact on Survival of Neo-adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma And Portal Vein Tumor Thrombosis (PVTT) Who Underwent Hepatectomy : A Random, Controlled, Stage III Clinical Trial.	NCT03368651	Hepatocellular ...	TAI	18 Years - 75 Years	Sun Yat-sen University
The Impact on Recurrence Risk of Adjuvant Transarterial Chemoinfusion (TAI) Versus Adjuvant Transarterial Chemoembolization (TACE) for Patients With Hepatocellular Carcinoma And Portal Vein Tumor Thrombosis (PVTT) After Hepatectomy : A Random, Controlled, Stage III Clinical Trial.	NCT03192644	Hepatocellular ...	TAI TACE epidoxorubicin ... mFOLFOX6 (oxali...	18 Years - 75 Years	Sun Yat-sen University

Spots Global Cancer Trial Database for tai

Every month we try and update this database with for tai cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for tai

Every month we try and update this database with for tai cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for tai cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.