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NCT ID: NCT05192798 Recruiting - Clinical trials for Triple-negative Breast Cancer

Albumin-Bound Paclitaxel Combined With Antiangiogenic Agents in First-line Treatment of Relapsed or Metastatic TNBC

Start date: January 14, 2022
Phase: Phase 2
Study type: Interventional

This is a prospective, randomized, open-label clinical study. 128 patients with relapsed or metastatic triple-negative breast cancer (TNBC) who had not been systematically treated are going to be enrolled and randomly assigned to 3 groups. Group A: albumin-bound paclitaxel (260mg/m2, intravenous infusion, once every 3 weeks). Group B: albumin-bound paclitaxel (260mg/m2, intravenous infusion, once every 3 weeks)+ apatinib mesylate tablet (500 mg, orally, once daily, every 3 weeks). Group C: albumin-bound paclitaxel (260mg/m2, intravenous infusion, once every 3 weeks) + bevacizumab (7.5mg/kg, intravenous infusion, once every 3 weeks). The dosages of therapeutic drugs are allowed to be adjusted appropriately according to the toxic reaction of the patients. Patients in three groups continued to take medication until disease progression/death/toxicity was intolerable/the patient or investigator decided to discontinue the medication. The primary endpoint is progression-free survival (PFS). Secondary endpoints are objective response rate (ORR), clinical benefit rate (CBR, complete response (CR)+ partial response (PR) + stable disease (SD, > 6 months)), overall survival (OS), adverse events (AE), and potential predictive biomarker parameters related to treatment response (VEGF-A expression level) in peripheral blood.

NCT ID: NCT05192759 Recruiting - Clinical trials for Transcranial Magnetic Stimulation

Effect of Theta-Burst Transcranial Magnetic Stimulation (TBS) for Freezing of Gait

Start date: November 22, 2021
Phase: N/A
Study type: Interventional

To investigate the treatment effect of Theta-burst Transcranial Magnetic Stimulation (TBS) on patients with freezing of gait (FOG) and the underlying neural mechanism.

NCT ID: NCT05192538 Recruiting - GERD Clinical Trials

A Novel Endoloop Pre-test to Treat Gastroesophageal Reflux

Start date: February 10, 2022
Phase: N/A
Study type: Interventional

The purpose of this study was to evaluate the safety and efficacy of endoscopic endoloop pre-test for gastroesophageal reflux before anti-reflux surgery or endoscopic treatment. In the study, the investigators used the novel pre-test to narrow the gastric cardia to control symptoms temporarily to decide whether to undergo irreversible surgery or endoscopic treatment.Thirty patients were enrolled and underwent endoscopic endoloop pre-test treatment. The Primary outcome in this study was measured by the percent reduction in post-procedure GERD symptoms as evidenced by analysis of the GERD-HRQL (Health Related Quality of Life) questionnaire. The secondary outcomes included improvement in esophageal 24-hr pH monitoring, improvement in quality of life questionnaires and safety. Patient follow-up assessments were completed at 7 and 14 days post treatment.

NCT ID: NCT05192525 Recruiting - Breast Cancer Clinical Trials

The Effects of a Nurse-led mHealth Program for Symptom Self-management of Breast Cancer Patients Undergoing Chemotherapy

mChemo
Start date: June 7, 2022
Phase: N/A
Study type: Interventional

Breast cancer (BC) survivors will experience multiple symptoms following chemotherapy. During the pandemic of COVID-19, the closure of clinics and fear of infection lead to BC patients' challenges in self-managing their multiple symptoms in home settings. Mobile health (mHealth), without time and space limitation, plays a positive role in supporting self-management and treatment compliance. However, previous mHealth self-management studies did not report sustained beneficial effects with physician-led supervision. In oncology practice, the nurse-led model of patient self-management for breast cancer has been placed on greater emphasis. Accordingly, an innovative nurse-led supervised mHealth program was designed to support self-management for BC patients undergoing chemotherapy. This pilot study aims to examine the feasibility and acceptability of a nurse-led mHealth-based self-management program for BC patients receiving chemotherapy, in order to provide evidence for conducting a definitive trial. The feasibility outcomes of the pilot study include subject eligibility rate, recruitment rate, and retention rate. The efficacy outcomes relate to self-efficacy (primary outcome), symptom distress and frequency, as well as health-related quality of life, and healthcare utilisation. The qualitative outcomes encompass patient- and provider-users' perceptions of the app usability and subjects' experiences of engaging in the pilot study.

NCT ID: NCT05192512 Recruiting - Advanced Cancer Clinical Trials

Clinical Trial of the TQB2928 Injection in Patients With Advanced Cancers

Start date: January 24, 2022
Phase: Phase 1
Study type: Interventional

TQB2928 is a promising new molecular entity that mediates blockade of CD47 and SIRPα (Signal Regulatory Protein Alpha) and enhances the phagocytosis of cancer cells by macrophages. This is a study to evaluate the safety, tolerability and effectiveness of TQB2928 injection in subjects with advanced malignancies.

NCT ID: NCT05192486 Recruiting - Clinical trials for Diffuse Large B-cell Lymphoma

A Study of GNC-038, a Tetra-specific Antibody, in Participants With R/R Diffuse Large B-cell Lymphoma (DLBCL)

Start date: August 10, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

In this study, the safety and preliminary efficacy of GNC-038 in participants with recurrent or refractory Diffuse Large B-cell lymphoma (DLBCL) will be investigated to assess the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) or maximum administered dose (MAD) for MTD is not reached of GNC-038. The recommended dose for phase II (RP2D) clinical study will also be determined.

NCT ID: NCT05192460 Recruiting - Gastric Cancer Clinical Trials

Safety and Efficacy of Personalized Neoantigen Vaccine in Advanced Gastric Cancer, Esophageal Cancer and Liver Cancer

Start date: March 28, 2022
Phase: N/A
Study type: Interventional

This trial is an investigator-initiated, single-center, open-label, single-arm exploratory study of mRNA neoantigen tumor vaccine in the treatment of advanced gastric cancer, esophageal cancer, and liver cancer, including two phases: dose escalation and dose expansion. To evaluate the safety and tolerability of neoantigen tumor vaccine in subjects with advanced gastric cancer, esophageal cancer and liver cancer by conducting dose escalation trial in subjects diagnosed with advanced gastric cancer, esophageal cancer and liver cancer, and preliminarily evaluate the efficacy of neoantigen tumor vaccine in subjects with advanced gastric cancer, esophageal cancer and liver cancer. According to the characteristics of safety and efficacy data in the dose escalation phase, the dose expansion is performed at the intended clinical dose based on the investigator's judgment, and the treatment is performed in combination with PD-1/L1 to further evaluate the efficacy and safety profile of neoantigen tumor vaccine at a specific dose. Both the dose escalation phase and dose expansion phase include a screening period (Week -4 ~ Week -2), a baseline period (Week -1 ~ Day -1), a treatment period (Day 1 ~ Week 8 or 16), and a follow-up period. Subjects who signed and provided the formal informed consent entered the screening period. The treatment period included the initial treatment period (Day 1 ~ Week 8) and the enhanced treatment period (Week 12 ~ Week 16). The investigator determined whether to enter the enhanced treatment period based on the comprehensive judgment of the subject's efficacy, safety, compliance and other factors from Week 8 to Week 12. The dose escalation phase follows standard 3+3 design. 12-18 subjects are expected to be enrolled at 3 given dose level. The investigator will choose the optimal clinical dose for dose expansion, which can be one dose group or multiple dose groups. PD-1/L1 drugs are used in parallel to further confirm the efficacy and safety of neoantigen tumor vaccine, with about 18 subjects. The usage and dosage of PD-1/L1 should aligned with the package insert.

NCT ID: NCT05191849 Recruiting - Clinical trials for Small Cell Lung Cancer

Circulating EV Long RNA Profiles in SCLC

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

To identify the circulating extracellular vesicle long RNA (exLR) profiles in small cell lung cancer (SCLC) and explore the potential of exLR as biomarkers to predict the therapeutic effect of SCLC.

NCT ID: NCT05191667 Recruiting - Esophageal Cancer Clinical Trials

AN0025 and Chemoradiotherapy Combination in Esophageal Cancer

Start date: January 18, 2022
Phase: Phase 1
Study type: Interventional

This is an open-label, multicenter, phase Ib study to evaluate the safety, tolerability, and preliminary efficacy of AN0025 in combination with chemoradiotherapy (CRT) in patients with locally advanced/locally recurrent esophageal cancer.

NCT ID: NCT05191602 Recruiting - Anastomotic Leakage Clinical Trials

The Relationship Between Drainage Fluid and Anastomotic Leakage After Colorectal Cancer Surgery

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

A prospective and analytical study on the detection of early anastomotic leakage by abdominal drainage fluid after colorectal cancer surgery. pay attention to indicators including bilirubin