Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Digestive System Diseases

Symptoms and General Pathology

Rare Diseases

Lung Neoplasms

Vascular Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Prostatic Neoplasms

Breast Neoplasms

Colorectal Neoplasms

Recurrence

Lymphoma

Leukemia

Thrombosis

Hemostatic Disorders

Blood Coagulation Disorders

Body Weight

Gastrointestinal Neoplasms

Intestinal Neoplasms

Lymphoproliferative Disorders

Myeloproliferative Disorders

Thromboembolism

Venous Thromboembolism

Venous Thrombosis

Urogenital Neoplasms

Digestive System Neoplasms

Lymphatic Diseases

Embolism

Embolism and Thrombosis

Lymphosarcoma

Chronic Myeloproliferative Disorders

Fibrinolytic Agents

Anticoagulants

All Drugs and Chemicals

Coagulants

Heparin

Hemostatics

Calcium heparin

Heparin, Low-Molecular-Weight

Tinzaparin

Dalteparin

Patients with objectively confirmed cancer associated venous thromboembolism receiving tinzaparin treatment to prevent recurrence of venous thromboembolism

Subcutaneous injection of 175 IU/kg once daily for 6 months

G Meyer, Professor

F Scotte, Dr

The purpose of this study is to validate the Ottawa score (risk of thromboembolic recurrences) in cancer patients with thromboembolic disease treated with tinzaparin (Innohep®)

The Ottawa score is a clinical predictive score aiming at stratifying thromboembolic recurrences in cancer patients according to identified clinical risk factors and histological type of the tumor. This score has never been validated externally in a prospective way in patients treated with tinzaparin. The objective of this observational prospective study is to enroll cancer patients with TED treated with tinzaparin for a planned period of 6 months and to collect data on thromboembolic recurrences, major hemorrhages, deaths and heparin-induced thrombocytopenia

Non Interventional Study of the Validation of the Ottawa Score in Cancer Patients With Venous Thromboembolism (VTE)

Prediction of Thromboembolic Recurrences in Cancer Patients With Venous Thromboembolic Disease (TED)

LEO Pharma

Postoperative Complications

Anti-Infective Agents

Amino Acids

PENTA

Fondaparinux

Factor Xa Inhibitors

Antithrombins

Antithrombin III

Protease Inhibitors

Serine Proteinase Inhibitors

HIV Protease Inhibitors

Enzyme Inhibitors

Serine

All patients will receive intermittent compression devices (ICD's) during the patient's entire hospitalization after the operative procedure. Patients randomized to the standard of care management will receive ICD's only. This represents the current standard of care at our institution at the time of initiation of the trial.

Patients randomized to treatment arm will initiate Arixtra (fondaparinux sodium) treatment on post-operative day 1 and continue treatment until post-operative day 22 (21 consecutive days). Subjects randomized to this arm are to receive the standard prophylactic dose for major abdominal surgery of 2.5 mg/day for a total of 21 consecutive days (including hospitalization time and after hospital discharge).

Treatment will consist of daily injections of pharmacy prepared syringes of Arixtra (fondaparinux sodium) 2.5mg. Treatment will continue for 21 consecutive days to end on post-operative day 22.

Arixtra (fondaparinux sodium)

Intermittent compression devices (ICD)

Warner K. Huh, M.D.

This is a randomized trial to compare intermittent compression devices with or without post-operative Arixtra (fondaparinux sodium) in women undergoing major abdominal surgery for known or presumed gynecologic malignancies. This trial seeks to determine if there is a difference in the rate of deep venous thrombosis between these two groups.

To assess the effectiveness of Arixtra (fondaparinux sodium) in the prophylaxis of deep venous thromboembolism in gynecologic oncology patients undergoing abdominopelvic surgery.

Study of Arixtra (Fondaparinux Sodium) to Prevent Blood Clots in Women Undergoing Abdominopelvic Surgery for Likely Gynecologic Malignancy

Extended Deep Venous Thrombosis Prophylaxis in Gynecologic Oncology Surgery With Intermittent Compression Devices (ICD) With or Without Postoperative Arixtra (Fondaparinux Sodium): A Randomized Controlled Trial

Deep venous thromboembolism (DVT) rates are determined from lower extremity doppler ultrasound measurements.

Adverse events will be evaluated to determine untoward effects.

GlaxoSmithKline

University of Alabama at Birmingham

Principal Investigator

Patients will receive standard intermittent compression devices (ICD's) during entire hospitalization after the operative procedure. Patients randomized to the standard of care management will receive ICD's only. This represents the current standard of care at our institution at the time of initiation of the trial.

Intermittent Compression Devices

Patients randomized to treatment arm will initiate ARIXTRA treatment on post-operative day 1 and continue treatment until post-operative day 22 (21 consecutive days). Subjects randomized to this arm are to receive the standard prophylactic dose for major abdominal surgery of 2.5mg/day for a total of 21 consecutive days (this includes both while in the hospital and after hospital discharge)

Arixtra (Fondaparinux Sodium)

Fondaparinux (Arixtra)

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

This trial was terminated early due to poor enrollment and recruitment and the very small number of subjects analyzed. As such, the data is uninterpretable.

Warner K. Huh, MD

Patients will receive intermittent compression devices (ICD's) during the entire hospitalization after the operative procedure. Patients randomized to the standard of care management will receive ICD's only. This represents the current standard of care at our institution at the time of initiation of the trial.

Patients randomized to the Arixtra arm will initiate treatment on post-operative day 1 and continue treatment until post-operative day 22 (21 consecutive days). Subjects randomized to this arm are to receive the standard prophylactic dose for major abdominal surgery of 2.5 mg/day for a total of 21 consecutive days (including hospitalization and after hospital discharge)

Planned Intention to Treat analysis but was unable to complete due to inadequate number of subjects enrolled.

Comparison of Deep Venous Thromboembolism (DVT) Using Intermittent Compression Devices With and Without Arixtra

Incidence of Untoward Effects With Arixtra

Overall Study

Rivaroxaban

Rivaroxaban 10mg orally per day for 90days

liu ting, master

yu bin, PHD

Rivaroxaban has been developed in the various clinical settings.Although cancer-associated DVT or PE was included in previously programs, limited patients of the total populations were cancer patients with totally implantable access ports in these studies. In this sense, investigators feel that new oral anticoagulants should be re-investigated in this highly specific patients group.Therefore, investigators are planning to conduct a prospective study to estimate the efficacy and safety of rivaroxaban for thromboprophylaxis in high-risk cancer patients with totally implantable access ports.

Rivaroxaban for Thromboprophylaxis in High-risk Cancer Patients With Totally Implantable Access Ports

The Efficacy and Safety of Rivaroxaban for Thromboprophylaxis in High-risk Cancer Patients With Totally Implantable Access Ports: a Prospective Randomized Controlled Trial

detect the occurrence of venous thrombosis with ultrasound, venography if necessary.

define occurrence of major-bleeding event with ISTH standard

define occurrence of non-major-bleeding or minor-bleeding event with ISTH standard, evaluate the relevant adverse drug reaction with NCI CTCAE 5.0

LiuZhou People's Hospital

Carcinoma

Carcinoma, Hepatocellular

Liver Neoplasms

Antineoplastic Agents

Hematinics

Bevacizumab

Atezolizumab

Liver Extracts

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Immune Checkpoint Inhibitors

Immunologic Factors

hepatic resection with post-operative atezolizumab 1200mg and bevacizumab 15mg/kg, both administered by IV infusion on Day 1 of each 21-day cycle

atezolizumab 1200mg and bevacizumab 15mg/kg, both administered by IV infusion on Day 1 of each 21-day cycle

atezolizumab 1200mg and bevacizumab 15mg/kg

hepatic resection with post-operative atezolizumab 1200mg and bevacizumab 15mg/kg

Surgery

Jia Fan

Huichuan Sun

Baocai Xing

Jianqiang Cai

Haitao Zhao

Jie Gao

Ledu Zhou

Tianfu Wen

Yifeng Tian

Yongyi Zeng

Minshan Chen

Ming Kuang

Xueli Bai

Weilin Wang

Lianxin Liu

Lin Wang

Lei Zhang

Xiangcheng Li

Bangde Xiang

Tao Peng

Yongjun Chen

Tianqiang Song

Zhiyong Huang

Deyu Li

The treatment strategies for HCC with PVTT is still controversial, and differ substantially between the west and the east. According to western guidelines, including those of the EASL, BCLC, and AASLD, PVTT is regarded as a contra-indication to initial surgery or transarterial chemoembolization.

At present, there is still no consensus on the diagnosis and treatment standards of HCC with HVTT/IVCTT. European and American guidelines for liver cancer use The Barcelona Clinic Liver Cancer (BCLC) staging as the standard and classify liver cancer with HVTT/IVCTT into the advanced stage. Molecular targeted drugs such as sorafenib and lenvatinib are recommended to the patients in this phase as first-line treatment drugs and methods. In this regard, experts in China and Southeast Asian countries still have different opinions. They believe that surgery, transarterial chemoembolization (TACE), radiotherapy, and combined treatment with multiple treatment methods can achieve more satisfactory results.

HCC with VTT consists of heterogeneous populations with different disease behaviors and prognoses. As a result of recent concept evolution and advances in surgical techniques and perioperative management, emerging evidence shows that selected patients with PVTT may benefit from more aggressive treatment modalities, which are recommended for by Chinese, Japanese, South Korean, and Asia Pacific clinical practice guidelines. A national survey from Japan showed median overall survival with liver resection treatment to be 1.77 years longer than with nonresection therapies, which included TACE, radiotherapy, sorafenib, or conservative treatment (2.87 years vs 1.10 years, respectively; p\<0.001). After propensity-score matching of patient baseline characteristics, median overall survival since diagnosis in the liver resection group was 0.88 years longer than in the non-resection group. In a large-scale, multicentre, propensity-score matched analysis from China, surgery was the best treatment for patients with Cheng's type I and II PVTT with Child-Pugh A and selected B liver function. Median overall survival after liver resection (745 of 1580 patients) was 15.9 months (95% CI 13.3-18.5 months) for Cheng's type I PVTT and 12.5 months (10.7-14.3 months) for Cheng's type II PVTT. Thus, aggressive surgical resection in selected patients with HCC with vascular invasion, as proposed by several tertiary health-care centers in the east, seems to be reasonable.

Currently, there are no dedicated clinical trials to study the value of hepatic resection in this population. Furthermore, cumulative evidence indicates that long-term overall survival after hepatic resection alone remains unsatisfactory because of the high rate of tumor recurrence and correspondingly low rate of disease-free survival. The combination of perioperative therapies may be more efficacious to improve the prognosis in selected population. More high-level evidence of novel multimodality treatment should be generated.

This trial will enroll HCC patients with PVTT CNLC Stage IIIa, who have no prior anti-cancer treatment. Given the poor prognosis and limited treatment options for these patients, this population is considered appropriate for trials of more aggressive and novel therapeutic candidates in the initial treatment setting. The benefit risk profile for hepatic resection combined with perioperative atezo/bev in this patient population is expected to be favorable.

This is a multicenter, open-label, two-arm, randomized study designed to evaluate the efficacy and safety of surgical resection plus peri-operative atezo/bev compared with continuous systemic atezo/bev in HCC patients with VTT and without EHS.

Initially eligible patients will be enrolled into induction phase, during which they will receive 3 cycles of atezo/bev and 1 cycle of atezo alone as primary systemic therapy. Tumor response assessment using computed tomography (CT) and/or magnetic resonance imaging (MRI) will be conducted by the Independent-Review Facility (IRF) according to RECIST v1.1 after cycle 2 and cycle 4.

Only those patients who are assessed as partial response (PR) or stable disease (SD) and considered suitable for curative hepatic resection will be randomized in a 1:1 ratio to one of the following two arms:

* Arm A (experimental arm): hepatic resection with post-operative atezolizumab 1200mg and bevacizumab 15mg/kg, both administered by IV infusion on Day 1 of each 21-day cycle
* Arm B (control arm): atezolizumab 1200mg and bevacizumab 15mg/kg, both administered by IV infusion on Day 1 of each 21-day cycle

Randomization will be performed after the second tumor assessment and stratified according to the following stratification factors:

* Tumor response: target lesion reduction (maximum diameter reduction ≥10% compared with the entry baseline) vs non-reduction
* Eastern Cooperative Oncology Group (ECOG) performance status: 0 vs 1 Those patients who are assessed as disease progression (PD) or complete response (CR) and/or not suitable for curative hepatic resection will be excluded from randomization and treated according to local practice (Patients without PD may continue atezo/bev treatment at investigators' discretion).

In Arm A, hepatic resection surgery will be performed 0-2 weeks after the randomization. Surgical approaches will be tailored to the individual patient according to local standards with the goal of achieving R0 resection. The first administration of postoperative atezo/bev treatment is recommended to start within 4-6 weeks after surgery, requiring full recovery from the surgery prior to post-operative atezo/bev treatment, including:

* Adverse events emerged from prior treatment, if any, should have been recovered to meet the requirements of atezo/bev treatment according to investigator's judgement.
* No significant medical events (e.g., gastrointestinal \[GI\] bleeding, cardiac events, hepatorenal syndrome, biliary fistula, serious infection, etc.) during or after the surgery procedure Treatment with atezo/bev will continue until loss of clinical benefit (determined by the investigator), or unacceptable toxicity, withdrawal of ICF, death, or the study is terminated by the Sponsor, whichever occurs first. For Arm A, whether to continue atezo/bev treatment will be determined by the investigator at the end of the 12-month treatment period if none of the above occurs.

Tumor assessments will be performed in induction phase after cycle 2 and cycle 4 (randomization baseline), and in treatment period at regular intervals (Arm A will receive tumor assessment at the first dose of postoperative treatment (±3 days）and every 9 weeks (±7 days）thereafter. Arm B every 9 weeks (±7 days）thereafter ). Additional scans will be performed as clinically indicated. Following completion or discontinuation of the treatment, information on recurrence or disease progression, survival and subsequent anti-cancer therapies will be collected until death, loss to follow-up, withdrawal of ICF or study termination by Sponsor, whichever occurs first. In the absence of disease recurrence or progression, tumor assessments should continue regardless of whether patients start a new anti-cancer therapy, until documented treatment failure events, withdrawal of ICF or study termination. All patients will be followed for survival unless consent is withdrawn.

Patients who withdraw from the study will not be replaced. An IRF will be used to enable centralized, independent reviews of images and other clinical data (e.g., histopathology, tumor markers etc.) used for assessment of HCC response, recurrence and disease progression. IRF reviews will be performed prior to the pre-specified efficacy analyses. IRF membership and procedures will be detailed in an IRF Charter.

A Study to Evaluate Efficacy and Safety of Hepatic Resection for Liver Cancer With PVTT, HVTT or IVCTT After Initial Ate/Bev

A Multicenter, Randomized, Open-label Study Evaluating the Efficacy and Safety of Hepatic Resection for Hepatocellular Carcinoma With Venous Thrombosis After Initial Atezolizumab Plus Bevacizumab Treatment

Nature, incidence, severity and seriousness of the adverse events/ADR. Adverse events are graded according to the NCI-CTCAE (Version 5.0)

Changes from randomization baseline in pulse rate

Changes from randomization baseline in respiratory rate

Changes from randomization baseline in blood pressure

Changes from randomization baseline in body temperature

Changes from randomization baseline in targeted physical findings

Changes from randomization baseline in hematology test result

Changes from randomization baseline in serum chemistry test result

Changes from randomization baseline in serology test result

Changes from randomization baseline in blood coagulation test result

Changes from randomization baseline in pregnency test result

Changes from randomization baseline in urinalysis test result

Changes from randomization baseline in C-reactive protein test result

Changes from randomization baseline in α-fetoprotein test result

Changes from randomization baseline in TSH(thyroid-stimulating hormone) test result

Changes from randomization baseline in free or total T3(Triiodothyronine) test result

Changes from randomization baseline in free T4(Thyroxine) test result

Recurrence-free survival (RFS) after randomization (Arm A), defined as the time from randomization to the first documented occurrence of local, regional, or metastatic HCC as determined by the IRF and the investigator, or death from any cause (whichever occurs first)

Time-to-Recurrence (TTR) after randomization (Arm A), defined as the time from randomization to the first documented occurrence of local, regional, or metastatic HCC, as determined by the IRF and the investigator

R0 rate (Arm A), defined as the proportion of patients who accomplish the complete resection of tumor with pathologically confirmed negative margin

Pathological complete regression (pCR) rate (Arm A), defined as the proportion of patients with no evidence of vital residual tumor cells on the complete resected specimen. pCR status will be analyzed by local pathologists at each site

Objective response rate (ORR) during atezo/bev treatment in induction phase before randomization and in Arm B after randomization, defined as the proportion of patients with a complete response (CR) or partial response (PR), as determined by the IRF and the investigator according to RECIST v1.1 and HCC mRECIST

Time-to-treatment failure (TTF) after randomization, defined as the time from randomization to the first documented treatment failure (i.e., local recurrence or progression, EHS, or death from any cause). Tumor response will be determined by the IRF according to RECIST v1.1

Overall survival (OS) after randomization, defined as the time from randomization to death from any cause

OS rate at 12 months, 18 months and 24 months, defined as the proportion of patients who have not experienced death from any cause at 12, 18 and 24months after randomization, respectively

TTF after randomization as determined by the investigator according to RECIST v1.1

TTF after randomization as determined by the IRF and the investigator according to HCC mRECIST

Time to EHS after randomization, defined as the time from randomization to first appearance of EHS, as determined by the IRF and the investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Non Interventional Study of the Validation of the Ottawa Score in Cancer Patients With Venous Thromboembolism (VTE)	NCT03099031	Venous Thromboe...	Tinzaparin	18 Years -	LEO Pharma
Study of Arixtra (Fondaparinux Sodium) to Prevent Blood Clots in Women Undergoing Abdominopelvic Surgery for Likely Gynecologic Malignancy	NCT00539942	Venous Thrombos...	Arixtra (fondap... Intermittent co...	19 Years - 85 Years	University of Alabama at Birmingham
Rivaroxaban for Thromboprophylaxis in High-risk Cancer Patients With Totally Implantable Access Ports	NCT04309240	Rivaroxaban Thromboprophyla... Cancer	Rivaroxaban	18 Years - 75 Years	LiuZhou People's Hospital
A Study to Evaluate Efficacy and Safety of Hepatic Resection for Liver Cancer With PVTT, HVTT or IVCTT After Initial Ate/Bev	NCT04649489	Venous Thrombos...	Atezolizumab Surgery	18 Years -	Fudan University
Post-thrombotic Syndrome & Predictors of Recurrence in Catheter-related Thrombosis	NCT01999179	Venous Thrombos... Neoplasms	Heparin, Low-Mo...	18 Years -	Medical College of Wisconsin
Rivaroxaban for Thromboprophylaxis in High-risk Cancer Patients With Totally Implantable Access Ports	NCT04309240	Rivaroxaban Thromboprophyla... Cancer	Rivaroxaban	18 Years - 75 Years	LiuZhou People's Hospital
A New Clinic-Genetic Risk Score for Predicting Venous Thromboembolic Events in Cancer Patient	NCT03114618	Cancer-associat... Genetic Predisp...		18 Years - 99 Years	Hospital General Universitario Gregorio Marañon
Optimal Duration of Anticoagulation Therapy for Low-risk Pulmonary Embolism Patients With Cancer	NCT04724460	Venous Thrombos... Neoplasms Anticoagulants	Long DOAC Short DOAC	20 Years - 80 Years	Kyoto University, Graduate School of Medicine
Pro-coagulant Markers and Anticoagulant Failure in Cancer Patients at Risk for Recurrence of Venous Thromboembolism	NCT01602445	Venous Thromboe... Deep-Vein Throm... Pulmonary Embol... Cancer		18 Years -	Ottawa Hospital Research Institute
A Study to Evaluate Efficacy and Safety of Hepatic Resection for Liver Cancer With PVTT, HVTT or IVCTT After Initial Ate/Bev	NCT04649489	Venous Thrombos...	Atezolizumab Surgery	18 Years -	Fudan University
Apixaban as Treatment of Venous Thrombosis in Patients With Cancer: The CAP Study	NCT02581176	Neoplasms Venous Thrombos...	Apixaban	18 Years -	University Hospital, Akershus

Spots Global Cancer Trial Database for venous thrombosis