Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Liver Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Lenvatinib

Immunomodulating Agents

Liver Extracts

Muromonab-CD3

Sorafenib

Protein Kinase Inhibitors

Enzyme Inhibitors

AlloStim® is a formulation of living allogeneic Th1-like cells with anti-CD3/CD28 microbeads attached derived from precursors purified from healthy screened blood donors that are differentiated and expanded ex-vivo. AlloStim® is formulated at 10-7 cells/ml in 0.5ml for ID administration and 3ml for IV administration

Physician's Choice is sorafenib or levantinib or FOLFOX4 monotherapy

3 cycles of intradermal and intravenous administrations

AlloStim® immunotherapy

Comparative arm: Physician Choice of FOLFOX4 chemotherapy

FOLFOX regimen

Comparative arm: Physician Choice of Sorafenib

Comparative Arm: Physician's Choice of Levantinib

Preechanoot Aimruen

Kanokwan Pornprasit

Farah Amalina Binti Mohamed Affandi, RN

Heng Chin Fong, MD

Siti Zurairah binti Md Saif, RN

Sen Chun Lim, MD

Ms Kamila, RN

Datuk Dr Muhammad Radzi Abu Hassan, MD

Mohd Khirul

Kananathan Ratnavelu, MD

Dharmaratnam Jeyandran, MD

Saranya Sarapat (คุณปุ้ย), RN

Krittiya Korphaisarn, MD

Nopparat Natekaew (น้องนุ๊ก), RN

Abhasnee Sobhonslidsuk, MD

Keson Trakunram, RN

Arunee Dechaphunkul, MD

Prathana Anekpunyakul, RN

Ekawee Sripariwuth, MD

This is a randomized, controlled multi-site, multi-national clinical trial conducted in Thailand and Malaysia for Asian adults (males or females), 18 years of age and older presenting with advanced HCC (BCLC stage C) including subjects with macrovascular involvement and/or extrahepatic spread (not eligible for TACE, surgery or locoregional treatment) with Child-Pugh stage A or B liver function. 150 subjects will be randomized 2:1 to AlloStim® immunotherapy vs Physician's Choice of Sorafenib, Lenvatinib or FOLFOX4.

A multi-national, randomized, controlled trial (RCT) with multiple sites selected in Asia (Malaysia and Thailand). Subjects with no prior treatments for BCLC stage C disease and presenting with Child-Pugh class A or B liver reserve to be randomized 2:1 to AlloStim® vs. Physician's Choice (PC). PC to be declared prior to randomization. PC allowed to be either sorafenib, levantinib or FOLFOX4.

The world incidence of hepatocellular carcinoma (HCC) is highest in East and South East Asia, with nearly half of the all HCC cases and deaths globally occurring in China. In Asian countries, the main treatment options for early or intermediate HCC (BCLC class A and B) include surgical resection, ablation (e.g., RFA, ETOH, cryoablation), transarterial chemoembolization (TACE), radiation or systemic chemotherapy depending on liver function status. However, in the Asian-Pacific region it is estimated that up to 80% of patients present with unresectable, advanced HCC (BCLC Stage C) that are not eligible for locoregional therapy, surgery or TACE due to tumor size and/or vascular involvement. For these patients, the standard of care for over a decade has been sorafenib (Bayer, A.G.), a oral kinase inhibitor based on the results of a RCT (SHARP study) of 602 patients randomized to sorafenib vs. placebo. Median overall survival (OS) was 10.7 months for sorafenib and 7.9 months for placebo (p\<0.05). The SHARP study included a Western population. A separate study in Asian patients (226 patients from China, South Korea and Taiwan) comparing sorafenib to placebo (Sorafenib-AP study) demonstrated a OS of 6.5 months for sorafenib compared to 4.2 months for placebo (p\<0.05). The placebo OS difference between Asian and Western patients (4.2mo vs 7.9 mo) suggests a difference in the disease characteristics in the Asian population. One significant difference is that the Asian population has an increased prevalence of HBV compared to Western population which may contribute to the increased incidence of HCC and worse OS outcomes observed in Asian patients compared to Western patients.

In Thailand and Malaysia sorafenib is not available to a majority of the population presenting with advanced HCC, both due to cost and toxicity profile. This study is designed to evaluate whether AlloStim ® immunotherapy will provide a survival benefit to this population with an improved quality of life compared to approved first line therapy.

Subjects are randomized 2:1 to experimental vs physician's choice. A two-sided logrank test with an overall sample size of 130 subjects (43 in the control group and 87 in the treatment group) achieves 80% power to detect at a 0.05 significance level a hazard ratio of 0.56 when the control group median survival is 6.5 months. A total of 150 subjects are planned to be accrued.

The investigator and subjects will be informed of the treatment group to which the subject has been randomized.

Immunotherapy for Advanced Liver Cancer

Phase II/III Randomized, Controlled Clinical Study of AlloStim(R) vs Physician's Choice in Asian Subjects With Advanced Hepatocellular Carcinoma

using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and the Functional Assessment of Cancer Therapy-Hepatobiliary Questionnaire (FACT-Hep)

To assess time to symptomatic progression (TTSP)

Mirror Biologics, Inc.

Immunovative Therapies, Ltd.

Infections

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Immune System Diseases

Uterine Cervical Neoplasms

Communicable Diseases

Acquired Immunodeficiency Syndrome

HIV Infections

Papillomavirus Infections

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Disease Attributes

Anti-Infective Agents

Anti-Retroviral Agents

Sophie Le Coeur, MD, PhD

Gonzague Jourdain, MD, PhD

Nicole Ngo-Giang- Huong, PharmaD, PhD

Isabelle Heard, MD, PhD

Aram Limtrakul, MD

Nantasak Chotivanich, MD

Chaiwat Putiyanun, MD

Samreung Rangdaeng, Associate professor

HIV-infected women are at high risk of developing cervical cancer. This is a 3-year cohort study nested in the already existing Program for HIV Prevention and Treatment (PHPT) cohort of HIV-infected patients in Thailand (NCT 00433030). The main objective is to assess the prevalence, incidence, and clearance rate of HPV cervical infection and associated cervical lesion. The study will also provide the distribution of the HPV genotypes involved as well as other risk factors of cervical lesions. HIV-infected women receiving antiretrovirals, older than18 years of age, followed in the PHPT cohort or in the same hospitals are proposed to participate. An annual gynecological examination with a Pap-smear and a sampling for HPV testing is performed. Women with abnormal Pap-smear or with High-Risk HPV (HR-HPV) infection receive a more intensive follow-up with a colposcopy and a biopsy if necessary. Treatment is provided according to the National Guidelines.

Title of the study: HPV Infection and Cervical Lesions in HIV infected Thai Women - A Prospective Study Country: Thailand Study period: 3 years Planned enrollment duration: 6 months

Primary objectives:

1. To evaluate the prevalence, the incidence, the persistence rate and the clearance rate of HPV cervical infection, of genotypes involved and of multiple infections.
2. To evaluate the prevalence, the incidence, the progression rate and the regression rate of cyto-histological abnormalities
3. To assess the efficacy of different screening algorithms using pap smear alone, pap-smear associated with HPV and HPV alone

Secondary objectives:

1. To determine the risk factors of high grade lesions (Cervical intraepithelial neoplasia (CIN)2 or higher) in HIV infected Thai women
2. To evaluate cyto-histology performances at different hospital levels Methods: A multicenter prospective cohort study nested in the PHPT cohort.

Inclusion criteria: HIV infected women, older than18 years of age, followed in the PHPT cohort or in the same hospitals.

Exclusion criteria: Virginity, total hysterectomy, pregnancy after 3rd month, inclusion in a HPV vaccination trial Planned number of patients to be enrolled: 884

Follow-up procedures:

Annual gynecological examination with a Pap-smear and a sampling for HPV testing is planned.

Women with abnormal Pap-smear or with High-Risk HPV (HR-HPV) infection will be referred to a colposcopist.

In case of abnormalities at the colposcopy, a biopsy will be performed.

* If the biopsy is normal or shows a CIN1, the women will be referred for a new colposcopic examination 6 months later.
* If the biopsy shows CIN2 or more, treatment will be provided -LEEP or conisation, or hysterectomy, and the women will be referred for a new colposcopic examination 6 months later.

Biological and pathological procedures:

* Pap-smears will be read by local pathologists in participating hospital.
* Biopsies will be read by local pathologists in participating hospital.
* HPV tests will all be performed in the PHPT virological laboratory in Chiang Mai.

Statistical methodology:

Descriptive statistics, univariate and multivariate analyses.

HPV Infection and Cervical Lesions in HIV Infected Women in Thailand: A Prospective Study

HPV Infection and Cervical Lesions in HIV Infected Women in Thailand

HPV16, HPV18, HPV31, HPV33, HPV35, HPV39, HPV45, HPV51, HPV52, HPV56, HPV58, HPV59, HPV68

Cervical intraepithelial neoplasia grade 2 or higher (CIN2+) in histology, and high grade squamous intraepithelial lesions or higher (HSIL+) in cytology

National Cancer Institute, France

Fondation de France

Institut de Recherche pour le Developpement

Rare Diseases

Stomach Neoplasms

Stomach Cancer

Thai patients who diagnosed gastric cancer

Japanese patients who diagnosed gastric cancer

Observe the treatments of gastric cancer in each group

Treatment

The differences in patient's clinicopathological characteristic between high and low prevalence of gastric cancer region should be further examined to elucidate factors that associate with poor survival rate of patients with gastric cancer. Therefore, this study aimed to evaluate characteristics of patients with gastric adenocarcinoma and factors associated with different outcome in Thailand and Japan to find a clue to improve patients' survival in low prevalence country such as Thailand.

This is a retrospective cohort study. It was conducted at King Chulalongkorn Memorial Hospital, Thailand and Osaka Medical Center for Cancer and Cardiovascular Disease, Japan. Eligible cases were selected by using standardized search protocols: formal computer searches of all patients seen at out-patient clinic and/or hospitalized for gastric cancer between 2010 and 2014.Two physicians, who were informed the definition of each variable, individually reviewed chart of patients.

Factors Associated With High Mortality of Gastric Adenocarcinoma in Thailand Versus Japan

Osaka Medical Center for Cancer and Cardiovascular Diseases

King Chulalongkorn Memorial Hospital

Principle investigator, Gastrointestinal Unit

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Immunotherapy for Advanced Liver Cancer	NCT05033522	Hepatocellular ...	AlloStim® immun... FOLFOX regimen Sorafenib Lenvatinib	18 Years - 80 Years	Immunovative Therapies, Ltd.
HPV Infection and Cervical Lesions in HIV Infected Women in Thailand: A Prospective Study	NCT01792973	Cervical Cancer		18 Years -	Institut de Recherche pour le Developpement
Factors Associated With High Mortality of Gastric Adenocarcinoma in Thailand Versus Japan	NCT03059732	Risk Factor	Treatment	18 Years -	King Chulalongkorn Memorial Hospital
Immunotherapy for Advanced Liver Cancer	NCT05033522	Hepatocellular ...	AlloStim® immun... FOLFOX regimen Sorafenib Lenvatinib	18 Years - 80 Years	Immunovative Therapies, Ltd.

Spots Global Cancer Trial Database for thailand

Every month we try and update this database with for thailand 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 thailand

Every month we try and update this database with for thailand 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 thailand 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.