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NCT ID: NCT04717531 Recruiting - Breast Cancer Clinical Trials

Pyrotinib as Neoadjuvant Agent for Non-objective Response HER2-positive Early Breast Cancer

Start date: June 3, 2021
Phase: Phase 2
Study type: Interventional

The study assesses the efficacy of neoadjuvant treatment with pyrotinib and trastuzumab with chemotherapy, mainly pathological complete response (pCR) rates in the breast and axilla. And also assesses side effects, event-free survival (EFS), disease-free survival (DFS), distant disease-free survival (DDFS), and objective response rates (ORR).

NCT ID: NCT04717414 Recruiting - Anemia Clinical Trials

An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis on Concomitant JAK2 Inhibitor Therapy and Who Require Red Blood Cell Transfusions

INDEPENDENCE
Start date: February 25, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this Phase 3 study is to evaluate the efficacy and safety of Luspatercept compared with placebo in subjects with myeloproliferative neoplasm (MPN)-associated Myelofibrosis (MF) and anemia on concomitant Janus kinase 2 (JAK2) inhibitor therapy and who require red blood cell count (RBC) transfusions. The study is divided into Screening Period, a Treatment Phase (consisting of a Blinded Core Treatment Period, a Day 169 Response Assessment, a Blinded Extension Treatment Period, and an Open-label Extension Treatment Period), and a Posttreatment Follow-up Period. Following the Day 169 Response Assessment, subjects who did not show clinical benefit will have the option to unblind. Subjects who were on placebo during the Blinded Core Treatment Period will have the opportunity to crossover into the Open-Label Extension Treatment Period and receive Luspatercept.

NCT ID: NCT04716686 Recruiting - Clinical trials for Endometrial Carcinoma

Niraparib Monotherapy as Maintain and Recurrent Treatment of Endometrial Serous Carcinoma

Start date: June 1, 2021
Phase: Phase 2
Study type: Interventional

Endometrial Serous carcinoma (ESC) has similar molecular characteristics to high-grade serous ovarian carcinoma (HGSOC) and basal cell-like breast cancer, such as similar Chromosomal instability, somatic copy number variation profiles and somatic mutations. The clinical treatment of ESC also refers to the treatment model of HGSOC. The PARP inhibitor niraparib used in this study, which was approved by FDA for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy on March 27, 2017. The homologous recombination related gene mutations in total endometrial cancer accounted for 22%. Homologous Recombination Repair Defect (HRD) +ARID1A accounted for 48%, and 53% of endometrial cancer cell lines were sensitive to PARP inhibitors. The incidence of HRD in endometrial cancer with high copy number (the pathological type is mainly ESC) is 50%, suggesting potential clinical applications of PARP inhibitors for the treatment of ESC.

NCT ID: NCT04716361 Recruiting - Clinical trials for Femoropopliteal Artery Occlusion

Outcome of Endovascular Therapies in Chronic Femoropopliteal Occlusive Disease With Severe Calcification

Start date: December 10, 2020
Phase:
Study type: Observational

This study is a prospective, multicenter, real world, observational study, which aims at evaluating the safety, efficacy and economic cost of endovascular treatments for endovascular therapies in chronic femoropopliteal occlusive disease with severe calcification. It is estimated that 400 subjects diagnosed with chronic femoropopliteal occlusive disease with severe calcification and receive endovascular treatments will be enrolled in eight centers nationwide from January 2021 to December 2022. All the subjects will be under follow-up for two years. There is no restriction on the endovascular techniques. The primary outcomes include the technical success rate of each endovascular techniques and the reintervention rate driven by lesions' clinical symptoms.

NCT ID: NCT04716257 Recruiting - Colorectal Cancer Clinical Trials

A Prospective, Multi-center, Real-world Study of Ovarian Metastatic Colorectal Cancer Patients

proOMCRC
Start date: January 14, 2021
Phase:
Study type: Observational [Patient Registry]

This prospective, multi-center, real-world study is conducted to investigate the impact of different treatment strategies (systemic chemotherapy combined with oophorectomy or with other local treatment or chemotherapy alone) on the prognosis of ovarian metastatic colorectal cancer patients.

NCT ID: NCT04716114 Recruiting - Clinical trials for Acute Myeloid Leukemia (AML)

A Study of SKLB1028 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory (R/R) AML With FLT3-Mutated

ALIVE
Start date: March 24, 2021
Phase: Phase 3
Study type: Interventional

This is a randomized,multicenter, open-label Phase III, clinical study to confirm the efficacy and safety of SKLB1028 in patients with relapsed or refractory(R/R) FLT3-Mutated Acute Myeloid Leukemia(AML)compared to salvage chemotherapy.

NCT ID: NCT04715672 Recruiting - Clinical trials for Anterior Cruciate Ligament Reconstruction;Resting State Functional Magnetic Resonance;Three-dimensional Gait Analysis;Return to Sports

The Establishment of Advanced Brain Function Evaluation Model for Anterior Cruciate Ligament Reconstruction

Start date: January 1, 2021
Phase:
Study type: Observational

It is difficult to establish the standard of return to sports post anterior cruciate ligament (ACL) reconstruction. The amplitude of low frequency fluctuation (ALFF) and functional connectivity (FC) of resting state functional magnetic resonance imaging (fMRI) can explore the differences in neural function of different populations, but have not been applied in the study of ACL postoperative return to sports.This project intends to use ALFF algorithm to calculate the changes of BLOD signals of coppers and non- coppers after ACL surgery in the subfrequency band and the functional network in the subfrequency band, explore the relationship between the default network (DMN) and the sensorimotor network (SMN), and use three-dimensional gait analysis to carry out accurate functional test..This project will explore the central strategy of ACL postoperative functional recovery from a new perspective, to provide a more reasonable high-level evaluation index for the timing of return to sports, and to reduce the incidence of postoperative re-tearing.

NCT ID: NCT04715620 Recruiting - Clinical trials for Recurrent Glioblastoma

Niraparib Combined With Radiotherapy in rGBM

Start date: January 2021
Phase: Phase 2
Study type: Interventional

Thirty patients were enrolled in this study, mainly patients with first recurrence of glioblastoma, and the requirement is that they can receive secondary radiotherapy. Regardless of whether the patient has received a second operation or the MGMT promoter is methylated, they can be included in this study. After enrollment, patients were given niraparib 300mg/day (body weight ≥77Kg and baseline platelet count ≥150,000/µL) or 200mg/day (body weight <77Kg or baseline platelet count <150,000/µL), combined with radiotherapy (total dose 55Gy), follow-up Time 1 year. Until the patient has disease progression or intolerance or voluntarily withdraw from the study.

NCT ID: NCT04715581 Recruiting - Surgery Clinical Trials

Multicomponent Prehabilitation and Outcomes in Elderly Patients With Frailty

Start date: November 25, 2021
Phase: N/A
Study type: Interventional

The study is designed to investigate the effect of a multicomponent prehabilitation pathway on early and long-term outcomes in elderly patients with frailty recovering from surgery for digestive cancer.

NCT ID: NCT04715529 Recruiting - Healthy Volunteers Clinical Trials

Phase 1 Study to Evaluate Safety and Pharmacokinetics of FZJ-003 in Healthy Volunteers

Start date: January 27, 2021
Phase: Phase 1
Study type: Interventional

A randomized, double-blinding, dose-escalated phase 1 trial to evaluate the tolerance and fasting/postprandial pharmacokinetics of FZJ-003, an oral Janus kinase1 (JAK1) inhibitor.