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

Coagulants

Doxorubicin

Liposomal doxorubicin

Chlorotrianisene

Gelatin Sponge, Absorbable

Ethiodized Oil

172 subjects in this study group will be receive the treatment of drug-eluting bead TACE

172 subjects in this study group will be receive the treatment of conventional TACE

Patients in the DEB-TACE group received a maximum dose of 4 ml of DC bead (diameter 75-500 um) loaded with a maximum dose of 150 mg of anthracyclines drugs, such as doxorubicin. The anticancer agents and the diameter of DC Bead for individual patient will be selected according to the common clinical practice of each center. Treatment endpoint consisted of stasis of flow within feeding vessel(s) or completed delivery of maximum single-session dose of 150 mg doxorubicin. TACE will be repeated "on demand" according to the radiological response.

DEB-TACE

Patients in the cTACE group were treated with anthracyclines, such as doxorubicin, in a mixture of lipiodol. Administration of the anticancer in oil emulsion was followed by injection of embolic materials such as gelfoam or PVA particles until complete stasis in segmental or subsegmental arterial branches. the tumor-feeding vessels should be superselected whenever possible. The anticancer agents for individual patient will be selected according to the common clinical practice of each center. TACE will be repeated "on demand" according to the radiological response.

cTACE

Guohong Han, MD PHD

Dongdong Xia, MD

this multi-center prospective cohort study is to evaluate the efficacy and the safety of drug-eluting bead TACE compared with conventional TACE in terms of objective response in unresectable HCC

Drug-eluting Bead Transarterial Chemoembolisation (DEB-TACE) Versus (VS) Conventional Transarterial Chemoembolisation (cTACE) for Unresectable Hepatocellualr Carcinoma (HCC)

Efficacy and Safety of Drug-eluting Bead TACE VS Conventional TACE for Unresectable Hepatocellular Carcinoma: a Multicenter, Prospective Cohort Study

the percentage of patients who achieved complete response (CR) and partial response (PR) as the best response, according to the modified Response Evaluation Criteria In Solid Tumours (mRECIST) criteria

Overall survival (OS) is measured from the treatment start until all-cause death or the last follow-up date

Time to progression is measured from the treatment start to the radiologically confirmed progression

The terms and grade of adverse event will be present according to the Common Terminology Criteria for Adverse Event (CTCAE version 4.0)

Progression-free survival (PFS) is measured from the treatment start until all-cause death or untreatable progression (vascular invasion, extra hepatic spread, the Eastern Cooperative Oncology Group (ECOG) performance status \>2, and Child-Pugh grade over C, but except hepatic new nodule)

Time to response (TTR) is measured from the treatment start to the firstly radiologically confirmed complete response or partial response.

Duration of response (DOR) is measured from the first-time confirmed complete response or partial response to the date of radiological progression

Air Force Military Medical University, China

Principal Investigator

Rare Diseases

Sarcoma

Neoplasms, Connective and Soft Tissue

Soft Tissue Sarcoma

Epithelioid Sarcoma

Irinotecan

Vincristine

a 90-minute intravenous infusion of irinotecan at a dose of 50 mg/m2/d for 5 days every 3 weeks, vincristine given at a dose of 1.4 mg/m2 (maximum 2 mg) on days 1 and 8, and oral administration of Anlotinib once daily on days 1-14 within a 21-day cycle.

VIA combination treatment

Epithelioid sarcoma is a rare soft tissue sarcoma characterized by SMARCB1/INI1 deficiency. Much attention has been paid to the selective EZH2 inhibitor tazemetostat, where other systemic treatments are generally ignored. To explore alternative treatment options, we studied the effects of irinotecan-based chemotherapy in a series of epithelioid sarcoma patients.

Irinotecan and Anlotinib for Epithelioid Sarcoma

A Retrospective Study Investigating the Combination of Irinotecan, Vincristine and Anlotinib for Epithelioid Sarcoma

Based on RECIST1.1 criteria, clinical evaluation was done once every 6 weeks

Peking University People's Hospital

Musculoskeletal Tumor Center

Nervous System Diseases

Diseases and Abnormalities at or Before Birth

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Neurofibromatoses

Neurofibromatosis 1

Neurofibroma

Neurofibroma, Plexiform

Nerve Sheath Neoplasms

Neoplasms, Nerve Tissue

Syndrome

Neoplastic Syndromes, Hereditary

Neurocutaneous Syndromes

Heredodegenerative Disorders, Nervous System

Neurodegenerative Diseases

Genetic Diseases, Inborn

Peripheral Nervous System Diseases

Neuromuscular Diseases

Nervous System Neoplasms

Peripheral Nervous System Neoplasms

Neurofibromatosis

Neurofibromatosis Type 1

orally 50 mg/dose, every 12 hours every day continuously (1 cycle = 28 days)

Selumetinib

Brigitte C Widemann, M.D.

Background:

Neurofibromatosis type 1 (NF1) is a disorder that can cause plexiform neurofibromas (PNs). These are tumors that grow along nerves. Some PNs cause serious health problems. PNs often can t be operated on because of their large size, location, or number. There are no effective treatments known for people with NF1 and PNs. Researchers want to test if the drug selumetinib (AZD6244 hydrogen sulfate) causes PNs to shrink or slows down their growth.

Objectives:

To test if selumetinib helps treat PNs. To test how the body handles selumetinib and how it affects peoples symptoms.

Eligibility:

People ages 18 and older with NF1, with an inoperable PN that causes morbidity or is growing

Design:

Participants will be screened with:

Medical history and physical exam

Blood, urine, and heart tests

Eye exam

MRI: They lie in a machine that takes pictures of the body.

PN biopsy: A small piece of the tumor is removed by a large needle.

Questionnaires

Participants will swallow selumetinib capsules every 12 hours for several 28-day cycles. The capsules are taken with a full glass of water on an empty stomach. Participants may have only water for 2 hours before and 1 hour after each dose.

Participants will keep a drug diary. They will continue taking the drug as long as they tolerate it and their disease doesn t progress.

Participants will have several visits throughout the study. These will include repeats of the screening tests.

Participants will have a final visit after they stop taking selumetinib.

Background:

* Neurofibromatosis 1 (NF1) is an autosomal dominant disorder with an incidence of 1:3500 in the US. One of the cardinal features of NF1 is the development of histologically benign peripheral nervesheath tumors called plexiform neurofibromas (PN) in 25-40% of individuals with NF1. Unlike discrete neurofibromas, PN grow along the length of nerves and involve multiple branches of a nerve. They are a major source of morbidity, causing disfigurement, impairment of nerve function, pain, and in some cases development of malignant peripheral nerve sheath tumors.
* Selumetinib (AZD6244) is a novel orally bioavailable mitogen activated protein kinase inhibitor, is a specific inhibitor of MEK 1/2, which may mediate anti-tumor effects in PN by inhibition of downstream signaling of Ras. Selumetinib is currently undergoing evaluation in adult cancers and children with brain tumors and NF1-related plexiform neurofibromas.
* In an NCI phase I trial of selumetinib for children and young adults with NF1 and inoperable PN we have observed preliminary activity with PN volume decrease in \>50% of patients enrolled. This degree of activity has not been observed in prior trials directed at PN. While preliminary activity has been seen in most patients enrolled to date, in several patients who required (Bullet) 1 dose reduction for toxicity, after an initial volume decrease, the PN volumes appear to be increasing slowly, and in one patient a nodular appearing lesion is not responding to selumetinib. These findings suggest that not all PN types may be responsive to selumetinib and that a certain selumetinib tissue concentration may be required for target inhibition and anti-tumor activity.

Objective:

-Determine the objective response rate (PN volume decrease greater than or equal to 20% compared to baseline) to selumetinib in adult patients with inoperable PN.

Eligibility:

* Patients must be at least 18 years of age with a diagnosis of NF1, with an inoperable, measureable PN that causes morbidity or is growing, which is amenable to percutaneous biopsy, and must be willing to undergo two biopsies.
* Up to 10 patients who meet all criteria, but have PN, which cannot be biopsied safely, will be eligible for the treatment portion of the study.
* Patients must have adequate organ function, be able to undergo serial MRI scans and have recovered from acute toxicity of all prior treatment.

Design:

* This is a single site open label phase II study in which all subjects will receive selumetinib orally approximately every 12 hours until patient develops progression of disease, unacceptable toxicity or, in patients with non-progressive, symptomatic PN at enrollment, a maximum of 2 years (unless they experience a partial response, or an improvement in symptoms or function in which case they may continue until progression of disease).
* Selumetinib will be administered at a dose of 50 mg BID on a continuous dosing schedule (1 cycle=28 days), which is the recommended adult dose. A maximum accrual of 35 evaluable patients to meet the primary objective; while a maximum of 60 patients in total may be enrolled to allow for a small number of screen failures, inevaluable patients and up to 10 patients who cannot safely undergo two biopsies of PNs. Enrollment will proceed over approximately 24 months.

MEK 1/2 Inhibitor Selumetinib (AZD6244 Hydrogen Sulfate) in Adults With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas

Phase II Trial of the MEK1/2 Inhibitor Selumetinib (AZD6244 Hydrogen Sulfate in Adults With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas

.All collected IPD will be shared. All IPD recorded in the medical record will be shared with intramural investigators upon request.

Evaluate immune infiltrate of PN and Peripheral blood for circulating tumor cells

Evalaute change in dermal neurofibroma by photography

Time to progression and progression free survival

Correlate 3D MRI responses with % target inhibition of pERK in PN biopsies

Compare pERK inhibition in dermal neurofibromas and PN

Characterize effects on pain, quality of life, physical functioning

Analyze paired biopsies with mechanisms of response and resistance

Analyze bone marrow derived precursor cells and cytokines before and after treatment

National Cancer Institute (NCI)

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Uterine Cervical Neoplasms

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

Paclitaxel

Albumin-Bound Paclitaxel

Cisplatin

Patients in group A don't receive neoadjuvant chemotherapy

Patients in group B receive neoadjuvant chemotherapy and achieve imaging response

Patients in group B receive neoadjuvant chemotherapy but don't achieve imaging response, and they accept concurrent chemoradiotherapy

Patients in group B receive neoadjuvant chemotherapy but don't achieve imaging response, and they accept radical hysterectomy

Two cycles of neoadjuvant chemotherapy (paclitaxel 175 mg/m2 and cisplatin 70 mg/m2, on day 1, once for three weeks).

Two cycles of neoadjuvant chemotherapy

First imaging evaluation consists of pelvic magnetic resonance imaging (MRI) and positron emission tomography (PET)

First imaging evaluation

Second imaging evaluation consists of pelvic magnetic resonance imaging

Second imaging evaluation

The third cycles of neoadjuvant chemotherapy (paclitaxel 175 mg/m2 and cisplatin 70 mg/m2, on day 1, once for three weeks).

The third cycles of neoadjuvant chemotherapy

Radiochemotherapy

Pathologic evaluation

Lei Li, M.D.

Lei Li, MD

This cohort study is to evaluate the role of neoadjuvant chemotherapy (NAC) in the treatment of locally advanced cervical cancer (LACC). Sixty patients with LACC (FIGO 2009 stage IB2 to IIB) will be enrolled. After informed consents, they would accept the imaging evaluation of pelvic magnetic resonance imaging (MRI) and positron emission tomography (PET). After excluding cases of distant metastasis, they will accept two cycles of NAC (paclitaxel 175 mg/m2 and cisplatin 70 mg/m2, on day 1, once for three weeks). Then a second MRI is performed to evaluate the imaging response. For patients achieving objective response, radical hysterectomy (RH, via laparoscopy or laparotomy) and an evaluation of pathologic response are performed. For patients without objective imaging response, the choice of concurrent chemoradiotherapy or radical hysterectomy will be discussed. After RH, adjuvant therapy will be given according to the RH pathologic results.

The primary objectives consist of (1) the objective imaging response after NAC; (2) the objective pathologic response after RH.

The secondary objectives consist of (1) disease-free survival and overall survival after various therapy modalities; (2) severe adverse effects of NAC; (3) the effects of NAC on the surgical outcomes.

patients diagnosed with locally advanced cervical cancer of stage IB2 to IIB (FIGO 2009 system)

NAC Followed by RH for the Treatment of LACC

Neoadjuvant Chemotherapy Followed by Radical Hysterectomy for the Treatment of Locally Advanced Cervical Cancer: A Prospective Cohort Study

Objective pathologic response for patients with radical hysterectomy

Objective imaging response for patients with neoadjuvant chemotherapy

Disease-free survival for patients with various therapy modalities

Overall survival for patients with various therapy modalities

Severe adverse events of neoadjuvant chemotherapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Drug-eluting Bead Transarterial Chemoembolisation (DEB-TACE) Versus (VS) Conventional Transarterial Chemoembolisation (cTACE) for Unresectable Hepatocellualr Carcinoma (HCC)	NCT03969576	Hepatocellular ...	DEB-TACE cTACE	18 Years -	Air Force Military Medical University, China
Irinotecan and Anlotinib for Epithelioid Sarcoma	NCT05656222	Objective Respo... Overall Surviva...	VIA combination...	3 Years -	Peking University People's Hospital
MEK 1/2 Inhibitor Selumetinib (AZD6244 Hydrogen Sulfate) in Adults With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas	NCT02407405	Neurofibromatos... Plexiform Neuro...	Selumetinib	18 Years -	National Institutes of Health Clinical Center (CC)
MEK 1/2 Inhibitor Selumetinib (AZD6244 Hydrogen Sulfate) in Adults With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas	NCT02407405	Neurofibromatos... Plexiform Neuro...	Selumetinib	18 Years -	National Institutes of Health Clinical Center (CC)
NAC Followed by RH for the Treatment of LACC	NCT03963882	Neoadjuvant Che... Locally Advance... Radical Hystere... Objective Respo... Laparoscopy Laparotomy Concurrent Chem... Adjuvant Therap... Systematic Chem...	Two cycles of n... First imaging e... Second imaging ... The third cycle... RH Radiochemothera... Pathologic eval...	18 Years - 45 Years	Peking Union Medical College Hospital

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