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NCT ID: NCT06341595 Recruiting - Gastric Cancer Clinical Trials

Concurrent Chemoradiotherapy Combined With Sintilimab as Neoadjuvant Therapy for GC Patients With PALM

Start date: April 1, 2024
Phase: Phase 2
Study type: Interventional

This trial is a prospective, single arm, single center, phase II clinical study aimed at subjects with advanced gastric cancer and para aortic lymph node metastasis, exploring the feasibility and safety of Sintilimab Injection combined with synchronous chemo-radiotherapy as neoadjuvant therapy. Patients will receive sintilimab Injection (200mg iv q3w d1) combined with concurrent radiotherapy and chemotherapy. The chemotherapy regimen will use oxaliplatin 130mg/m2+S-1 40mg/m2 bid d1-14. Radiotherapy is performed using intraperitoneal radiation therapy, once a day, five times a week, at a dose of 1.8-2 Gy/f, for a total of 45-50.4 Gy (60-66 Gy for lymph node lesions). Radiation therapy starts from the second cycle of Sintilimab Injection combined with chemotherapy. The subjects underwent imaging evaluation after completing 4 cycles of combination chemotherapy and radiation therapy with Sintilimab Injection. Evaluated as a surgical subject (surgical conditions: imaging evaluation of enlarged lymph nodes adjacent to the abdominal aorta with PR or no significant activity), radical surgery will be performed within 4 weeks after the last study drug treatment. After surgery, the researcher will determine the necessity of adjuvant treatment and develop an adjuvant treatment plan based on the subject's condition. Subjects evaluated as inoperable will have their best follow-up treatment plan determined by the researcher.

NCT ID: NCT06341582 Recruiting - Neonatal Jaundice Clinical Trials

Prediction and Evaluation by ETCOc of Neonatal Hyperbilirubinemia Cohort

PREVENT
Start date: December 11, 2023
Phase:
Study type: Observational [Patient Registry]

The hemolytic disease of newborns (HDN) is one of the most significant risk factors for hyperbilirubinemia. Studies have shown that end-tidal carbon monoxide-corrected (ETCOc) correlated with the rate of bilirubin production in the body and thus can be a good surrogate to quantify hemolysis and identifying the high-risk infants. However, there is insufficient clinical evidence regarding the early prediction of hemolytic hyperbilirubinemia using ETCOc. This study hypothesizes that early postnatal ETCOc levels are significantly associated with the risk of hemolytic hyperbilirubinemia requiring treatments within 14 days after birth, and early postnatal ETCOc can be a good indicator for early prediction of hemolysis. In addition, the investigators aim to investigate the relationship between the characteristics of treatments for hyperbilirubinemia and ETCOc.

NCT ID: NCT06341556 Recruiting - Clinical trials for Mantle Cell Lymphoma

A Multicenter, Prospective, Phase II Study of Zanubrutinib for Maintenance in Patients With Mantle Cell Lymphoma

Start date: April 2024
Phase: Phase 2
Study type: Interventional

This study aims to evaluate whether maintenance therapy with Zanubrutinib monotherapy could improve the 2-year progression free survival (PFS) of patients with mantle cell lymphoma who had remission after first-line immunochemotherapy

NCT ID: NCT06341530 Recruiting - Clinical trials for Non-small Cell Lung Cancer

Anlotinib Combined With Penpulimab as Front-line Treatment in Advanced Non-small Cell Lung Cancer

Start date: January 31, 2024
Phase: Phase 2
Study type: Interventional

In recent years, with the emergence and clinical application of anti-angiogenesis therapy, the therapeutic effect of patients has been significantly improved while ensuring that the adverse reactions of patients do not increase. Anti-angiogenic therapy can improve the hypoxia state of tumor tissue, normalize blood vessels, relieve immune suppression in tumor microenvironment, increase the degree of infiltration of immune cells, and fully activate immune cells to achieve the effect of tumor immunity. Previous studies have shown that penpulimab injection combined with anlotinib in the treatment of NSCLC can induce the normalization of tumor blood vessels and reshape the tumor immunosuppressive microenvironment, and the combination of the two can have synergistic effects. This study intends to treat patients with advanced non-small cell lung cancer (NSCLC) confirmed by pathology with the combination of anlotinib and penpulimab injection, and observe the efficacy and safety of anlotinib and penpulimab injection in the first and second lines of NSCLC. This study is expected to provide a reference for the treatment strategy of advanced non-small cell lung cancer patients, and has important clinical value for the treatment of advanced lung cancer.

NCT ID: NCT06341400 Recruiting - Bladder Cancer Clinical Trials

RC48 Combined With Toripalimab as Neoadjuvant Therapy for Cisplatin Ineligible MIBC Patients

Start date: May 20, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

A single-arm, prospective, exploratory clinical trial to explore the pathological complete response (pCR) rate of immune checkpoint inhibitors combined with antibody conjugate drugs as the perioperative treatment of platinum-intolerant bladder cancer patients. Fifty-five patients with clinically or pathologically confirmed muscle-invasive bladder urothelial carcinoma (MIBC) who were ineligible for cisplatin-based chemotherapy or refused cisplatin-based chemotherapy were enrolled. Each subject will receive RC48-ADC and toripalimab intravenously every 2 weeks for a total of 4 cycles before surgery, 8 cycles after surgery. The efficacy was evaluated and followed up after 4 cycles of neoadjuvant therapy, 3 months postoperative, and every 3-6 months thereafter. The primary endpoint of this study was pathological complete response rate (pCR). The secondary endpoints were to explore the safety, disease-free survival (DFS), overall survival (OS), objective response rate (ORR) and disease control rate (DCR) of RC48 combined with toripalimab neoadjuvant therapy followed by radical cystectomy.

NCT ID: NCT06341283 Not yet recruiting - Breast Cancer Clinical Trials

A Retrospective Real-world Study of Abemaciclib in HR+ Breast Cancer

Start date: June 1, 2024
Phase:
Study type: Observational

The present study will assess real-world clinical outcomes, adverse events and economics from treatment with endocrine therapy(ET) combined with abemaciclib in patients with hormone receptor-positive(HR+) breast cancer.

NCT ID: NCT06341270 Not yet recruiting - Liver Cancer Clinical Trials

Efficacy of TEAS on Postoperative Pain and Recovery in Patients Undergoing Hepatectomy

Start date: April 20, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to access the effect of transcutaneous electrical acupoint stimulation on postoperative pain in patients undergoing hepatectomy

NCT ID: NCT06341231 Recruiting - Clinical trials for Anticoagulants; Increased

Personalized Anticoagulant Therapy for Pulmonary Thromboembolism

Start date: February 1, 2024
Phase:
Study type: Observational

The goal of this prospective observational study is to explore the influencing factors of the efficacy and safety of anticoagulant therapy for pulmonary thromboembolism in special populations with older age, renal insufficiency or co-existing malignancy, and establish a predictive model to guide clinical practice. The main questions it aims to answer are: - To analyze the influencing factors of the efficacy and safety of anticoagulant therapy for specific populations with pulmonary thromboembolism (PTE) in the real world (such as the elderly, those with impaired kidney function, and individuals with malignant tumors). - Whether we can use machine-learning models to predict bleeding events and VTE recurrence in special populations following anticoagulant therapy in the real world? Participants will receive diagnostic and therapeutic measures for pulmonary thromboembolism in accordance with clinical guidelines, including anticoagulant therapy. Some patients need to have peripheral blood samples collected at the time of enrollment and 3 months after anticoagulant therapy.

NCT ID: NCT06341114 Recruiting - Clinical trials for Advanced Solid Tumors

A Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of the Combination of BAT8008 With BAT1308 in Patients With Advanced Solid Tumors

Start date: April 12, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

The study, led by Zhejiang Cancer Hospital and sponsored by Bio-Thera Solutions, Ltd., is an exploratory multicenter, open-label phase Ib-II clinical trial evaluating the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of the combination of BAT8008 with BAT1308 in patients with advanced solid tumors. This study aims to explore the safety, tolerability, and pharmacokinetic characteristics of BAT8008 combined with BAT1308 in patients with advanced solid tumors, determine the maximum tolerated dose (MTD), provide recommended doses and reasonable dosing regimens for subsequent clinical studies, and preliminarily evaluate the antitumor efficacy. The study is divided into two stages. The first stage will use a "3+3" dose escalation design to explore the safety and tolerability of the investigational drugs. In the second stage, based on the preliminary safety and efficacy results from the first stage, appropriate doses and tumor types will be selected for expansion studies within the safety dose range to further investigate the safety and clinical efficacy of BAT8008+BAT1308 and provide evidence for subsequent clinical studies.

NCT ID: NCT06341075 Enrolling by invitation - Clinical trials for Drug Resistant Epilepsy

Real-World Study of Magnetic Resonance-guided Laser Interstitial Thermal Therapy for Drug-resistant Epilepsy

Start date: March 14, 2024
Phase: N/A
Study type: Interventional

The goal of the real-world study is to evaluate the long-term seizure control outcomes, postoperative complications, long term impact on cognitive, memory function outcomes, quality-of-life measures, and healthcare resource utilization of magnetic resonance-guided laser interstitial thermal therapy (MRgLITT) on patients with drug-resistant epilepsy (DRE).