Neoplasms

All Conditions

Digestive System Diseases

Heart and Blood Diseases

Carcinoma

Carcinoma, Hepatocellular

Thrombosis

Liver Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

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

Sun Yat-sen University

Cancer Center, Sun Yat-sen University

Rare Diseases

Carcinoma, Squamous Cell

Esophageal Neoplasms

Esophageal Squamous Cell Carcinoma

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Esophageal Diseases

Esophageal Cancer

Paclitaxel

Cetuximab

Albumin-Bound Paclitaxel

Cisplatin

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Cetuximab, injection, loading dose400 mg/m\^2,(Day1 in Week1) followed by 250 mg/m\^2(Day1, every week for Weeks 2-8) Paclitaxel, injection,45 mg/m\^2 (Day 1, every week for Weeks 2-8) Cisplatin, injection,20 mg/m\^2 (Day 1, every week for Weeks 2-8) radiation therapy, 59.4 Gy, 1.8 Gy/33 fractions,1 fraction daily, Days 1-5 every week for Weeks 2-7, and Days 1-3 for Week 8

Cetuximab,injection,loading dose400 mg/m\^2,(Day1 in Week1) followed by 250 mg/m\^2(Day1, every week for Weeks 2-8)

cetuximab (Erbitux)

Paclitaxel,injection,loading dose 45 mg/m\^2,(Day1 in every week for Weeks 2-8)

Cisplatin,injection,loading dose 20 mg/m\^2,(Day1 in every week for Weeks 2-8)

Radiation, External beam therapy, total 59.4 Gy , 33 fractions, 1.8 Gy per fraction.(Day 1-Day 5 in every week 2-week 8).

Radiation

Jin Ming Yu, PH.D, M.D

The purpose of this study is to determine whether the treatment of locally advanced esophageal squamous cell carcinoma (ESCC)with cetuximab in combination with paclitaxel, cisplatin and radiation improve clinical outcomes.

Esophageal cancer is the sixth leading cause of cancer death worldwide.

Over the past 2 decades, well-designed clinical trials have documented the clinical benefits of combination of chemotherapy and radiation for localized esophageal cancer, either as primary therapy or in neoadjuvant setting.

Paclitaxel, a radiation sensitizer, has important single-agent activity in esophageal cancer. Paclitaxel-based chemoradiation has been the framework for the recent Radiation Therapy Oncology Group (RTOG) trials of nonoperative management of esophageal cancer.

Accumulating clinical evidence suggests that epidermal growth factor receptor (EGFR) represents a viable target in the treatment of esophageal cancer. EGFR expression is associated with poor prognosis. Cetuximab, a monoclonal antibody, binds specifically to EGFR on both normal and tumor cells and competitively inhibits the binding of EGF and other ligands, such as transforming growth factor (TGF)-α.

Preclinical models have suggested synergy between cetuximab, paclitaxel, cisplatin and radiation. For patients with locally advanced head and neck cancer, the combination of cetuximab and radiation has demonstrated both response and survival benefit.

With all these, the investigators hypothesize that treatment of locally advanced esophageal squamous cell carcinoma (ESCC)with cetuximab in combination with paclitaxel, cisplatin and radiation may further improve clinical outcomes. This trial results will be important as it may support further studies for setting the new treatment standard for ESCC.

Erbitux Combined With Chemo-radiotherapy in Esophageal Squamous Cell Carcinoma

An Open-labeled Study to Evaluate Efficacy of Combining Erbitux Plus Concurrent Chemo-radiotherapy in Locally Advanced Esophageal Squamous Cell Carcinoma (ESCC)

The overall response rate was defined as the numbers of patients with a complete response (CR) or partial response (PR). CR was defined as no target lesion at follow-up computed tomography scan and barium swallow examination 3-6 weeks after completion of chemo-radiation. PR was defined at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

All patients were regularly monitored for possible adverse events, which were graded according to National Cancer Institute Common Toxicity Criteria version 3.0.

DNA was extracted from tumor specimens.Screened for the presence of KRAS codon 12 and 13 mutations using a PCR clamping and melting curve technique. PCR amplification of the wild-type KRAS sequence was suppressed in this process by the incorporation in the reaction mix of a locked nucleic-acid oligomer16 spanning codons 12 and 13 of the KRAS gene. Post-PCR hybridization and melting curve analysis using fluorescently tagged oligonucleotides incorporated in the original PCR reaction permitted the identification and discrimination of distinct KRAS codon 12 and 13 missense mutations.

Chinese Academy of Medical Sciences

Peking University Cancer Hospital & Institute

Hebei Fourth Hospital

Jiangsu Cancer Institute & Hospital

RenJi Hospital

The Affiliated Cancer Hospital of Zhengzhou University

West China Hospital

Shandong Cancer Hospital and Institute

Jinming Yu

Cetuximab, Concurrent Chemo-radiotherapy

Age, Categorical

Age Continuous

Sex: Female, Male

China

Region of Enrollment

Number of Participants With Overall Response Rate (RR)

Number of Participants With Toxicity

Participants With Overall Survival (OS) at 1 Year

Participants With Overall Survival (OS) at 3 Year

Participants With Progression Free Survival (PFS)

Number of Participants With K-ras Gene Mutation

Overall Study

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Breast Neoplasms

Carcinosarcoma

Mixed Tumor, Mullerian

Endometrial Neoplasms

Adenoma, Pleomorphic

Breast Diseases

Skin Diseases

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Sarcoma

Neoplasms, Connective and Soft Tissue

Malignant Mixed Mullerian Tumor

Soft Tissue Sarcoma

Patients then undergo 25% caloric intake for 3-12 weeks prior to definitive cancer surgery.

Dietary Intervention

Counseling

Therapeutic

Nicole Simone, MD

The purpose of this trial is to determine that sort term calorie restriction will affect tumor biology in biopsy proven breast, endometrial or prostate cancers, which will positively impact biomarkers including miR-21, an onco-miR known to impact cancer outcomes.

PRIMARY OBJECTIVES:

1) Investigate if caloric restriction will change serum micro ribonucleic acid (RNA) 21 (miR-21) expression in patients with prostate, endometrial or breast cancer.

SECONDARY OBJECTIVES:

1. Investigate measurable changes induced by caloric restriction on both patient (host) and tumor characteristics from caloric restriction.
2. Investigate the adherence of the patient to the diet.

4) Weight, height, and body composition will be assessed via BodyMetrix. BodyMetrix uses ultrasound technology to measure subcutaneous fat.

5) Patients will have psycho-social evaluation using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) test (prostate cancer), FACT-Breast (B) test (breast cancer), or the FACT-Endometrial Cancer (En) test (endometrial cancer) and the Patient Reported Outcomes Measurement Information System (PROMIS) cancer fatigue short form at baseline, midway through diet, and at the conclusion of the diet.

6) Patient's nutritional status (Mini Nutritional Assessment \[MNA\] form) will be assessed, and their caloric needs will be calculated.

7) Local recurrence, progression free survival, distant metastases and overall survival will be assessed.

Caloric Restriction Before Surgery in Treating Patients With Endometrial, Prostate, or Breast Cancer

Caloric Restriction for Oncology Research: Pre-operative Caloric Restriction Prior to Definitive Oncologic Surgery

Will be evaluated by a two-sided paired t-test at significance level 0.05.

Will be assessed by modeling BMI as a function of time via mixed-effects regression.

Will be assessed as a function of time via mixed-effects regression.

Initial cancer biopsy specimen for genomic analysis will be comped to definitive surgical specimens.

Will be analyzed via survival methods, specifically the Kaplan-Meier method and the log-rank test. If sufficient events occur, may assess the impact of various patient and clinical/treatment variables on these outcomes via Cox proportional hazards regression. Will be assessed and compared with historic controls using the Kaplan Meier method.

Sidney Kimmel Cancer Center at Thomas Jefferson University

Symptoms and General Pathology

Blood and Lymph Conditions

Fibrosis

Myeloproliferative Disorders

Polycythemia Vera

Polycythemia

Primary Myelofibrosis

Thrombocytosis

Thrombocythemia, Essential

Splenomegaly

Bone Marrow Diseases

Hematologic Diseases

Bone Marrow Neoplasms

Hematologic Neoplasms

Blood Platelet Disorders

Hemostatic Disorders

Blood Coagulation Disorders

Hemorrhagic Disorders

Chronic Myeloproliferative Disorders

Essential Thrombocythemia

intravenous in dose cohorts of 70mg/m2 or 180 mg/m2

AVID200

John Mascarenhas, MD

Ruben Mesa, MD

Ronald Hoffman, MD

Increased levels of TGF-β1 were detected in serum, plasma and BM and positively correlated with both grade of BMF and extent of leukemic cell infiltration in the marrow. TGF-β likely plays a dual role in promoting myelofibrosis and myeloproliferation, both of which are the bone marrow morphologic hallmark of MF. AVID200 is a drug that targets TGF-β1 and TGF-β3. The study team hypothesizes that inhibiting the TGF-β signaling pathway in MF will decrease the fibrogenic stimuli leading to myelofibrosis and concomitantly interrupt myeloproliferation and restore normal hematopoiesis.

This is a first in human, open-label, multicenter, Phase I/Ib trial of AVID200. Patients must have intermediate-2 or higher primary myelofibrosis (PMF), post-essential thrombocythemia or polycythemia-vera related MF (Post ET/PV MF). This study will enroll up to 24 patients. AVID200 is delivered by IV infusion on day 1 of each 3 week cycle.

This is a first in human, open-label, multicenter, Phase I/Ib trial of AVID200. To date, there is no therapy for MF evaluated in the clinic that clearly demonstrates the ability to target the malignant HSC and result in effective and reproducible bone marrow morphologic, cytogenetic and molecular responses. Medicinal therapies that result in disease course modification are urgently needed in this chronic and progressive myeloid malignancy. TGF-β likely plays a dual role in promoting myelofibrosis and myeloproliferation, both of which are the bone marrow morphologic hallmark of MF. The study team proposes that inhibiting the TGF-β signaling pathway in MF will decrease the fibrogenic stimuli leading to myelofibrosis and concomitantly interrupt myeloproliferation and restore normal hematopoiesis. AVID200 is a fusion protein containing TGF-β receptor ectodomains fused to a human Fc IgG domain. AVID200 is a potent TGFβ trap with antibody-like properties which has pM potency against two of the three TGFβ ligands, TGFβ1 and β3.

MPN-RC 118 AVID200 in Myelofibrosis

Phase I Study of AVID200 in Patients With Myelofibrosis (Myeloproliferative Neoplasms Research Consortium [MPN-RC] 118)

Cohorts of 3 patients with a maximum evaluable sample size of 12 patients and a target toxicity rate of 30% to estimate the MTD. Each cycle is 21 days.

Subjects attaining at least a CI (clinical improvement) by IWG/ELN criteria, or a decrease in bone marrow fibrosis by ≥1 grade with otherwise stable disease, will be allowed to continue AVID200 in the extension phase of the trial.

response by IWG/ELN criteria at the end of Cycle 6 and Cycle 12. The IWG/ELN criteria: CR (complete remission), PR (partial remission), Clinical improvement, Anemia response, Spleen response, Symptoms response, PD (progressive disease), SD (stable disease), Relapse, Cytogenetic remission, and Molecular remission

bone marrow fibrosis grade at the end of Cycle 6 and 12. Bone marrow fibrosis (MF) is graded as MF-0 to MF-3, with higher number indicating more disease.

MF-SAFv4.0,each of the items are scored 0 to 10, with total summation from 0 to 100, with higher score indicating more symptoms.

EORTC QLQ-C30, 28 item scored from 1 (not at all) to 4 (very much), and 2 items scored 1 (very poor) to 7 (excellent). Total score from 28 - 126, with higher score indicating poorer health

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
Erbitux Combined With Chemo-radiotherapy in Esophageal Squamous Cell Carcinoma	NCT00815308	Esophageal Canc...	cetuximab (Erbi... Paclitaxel Cisplatin Radiation	18 Years - 70 Years	Shandong Cancer Hospital and Institute
Erbitux Combined With Chemo-radiotherapy in Esophageal Squamous Cell Carcinoma	NCT00815308	Esophageal Canc...	cetuximab (Erbi... Paclitaxel Cisplatin Radiation	18 Years - 70 Years	Shandong Cancer Hospital and Institute
Caloric Restriction Before Surgery in Treating Patients With Endometrial, Prostate, or Breast Cancer	NCT02983279	Breast Carcinom... Endometrial Car... Prostate Carcin...	Dietary Interve... Counseling Therapeutic	18 Years -	Thomas Jefferson University
MPN-RC 118 AVID200 in Myelofibrosis	NCT03895112	Primary Myelofi... Post-essential ... Post-polycythem... Post ET MF Post PV MF	AVID200	18 Years -	Icahn School of Medicine at Mount Sinai
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
Erbitux Combined With Chemo-radiotherapy in Esophageal Squamous Cell Carcinoma	NCT00815308	Esophageal Canc...	cetuximab (Erbi... Paclitaxel Cisplatin Radiation	18 Years - 70 Years	Shandong Cancer Hospital and Institute

Spots Global Cancer Trial Database for therapeutic

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

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