Clinical Trials Logo

Filter by:
NCT ID: NCT05027828 Recruiting - Clinical trials for Circulating Tumor DNA

CtDNA as a Novel Biomarker of Treatment Efficacy in Patients With Ovarian Cancer

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

This study is a prospective observational clinical trial. Patients who were diagnosed and treated for the first time were enrolled and their surgical pathology was confirmed to be high-grade serous ovarian cancer. At the same time, these patients will receive first-line maintenance treatment with PARP inhibitors after traditional chemotherapy. During the trial period, patients' plasma will be collected before surgery, after chemotherapy, during targeted maintenance therapy, and during disease progression, and ctDNA-specific genomes will be detected, and clinical data will be collected over the same period. It is expected that specific ctDNA can be used to predict the efficacy of PARP inhibitors in patients with ovarian cancer, and to detect the recurrence of the disease early.

NCT ID: NCT05027776 Recruiting - Vaginal Cancer Clinical Trials

Immunogenicity and Safety of Quadrivalent HPV Vaccine in Healthy Chinese Female Subjects Aged 9 to 19 Years

Start date: September 15, 2021
Phase: Phase 3
Study type: Interventional

This phase 3 study will evaluate the immunogenicity and safety of Quadrivalent HPV recombinant vaccine in Chinese females aged 9 to 26 years

NCT ID: NCT05027386 Recruiting - Neuroblastoma Clinical Trials

Apatinib Mesylate Combined With IT Regimen for the Treatment of Recurrent or Refractory Pediatric Neuroblastoma

Start date: August 26, 2021
Phase: Phase 2
Study type: Interventional

The survival rate of recurrent and refractory pediatric neuroblastoma is low and the prognosis is poor. Apatinib mesylate is a highly selective small-molecule vasoendothelial growth factor receptor-2 (VEGFR-2) tyrosine kinase inhibitor. Apatinib mesylate has been shown to be safe and effective in recurrent or refractory pediatric neuroblastoma in Sun Yat-sen University Cancer Center. Apatinib mesylate combined with IT regimen is expected to further improve the efficacy and survival rate of recurrent or refractory pediatric neuroblastoma.

NCT ID: NCT05027373 Recruiting - Clinical trials for Systemic Juvenile Idiopathic Arthritis

Safety, Tolerability and Pharmacokinetic of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection

Start date: August 13, 2021
Phase: Phase 1
Study type: Interventional

This study is Safety, Tolerability and Pharmacokinetic of Recombinant anti-IL-1β Humanized Monoclonal Antibody injection in Healthy Subjects. Pharmacokinetics, Pharmacodynamics and Anti-drug antibody (ADA) data will be collected; Drug safety, tolerability and immunogenicity for healthy subjects will be evaluated.

NCT ID: NCT05027204 Recruiting - Clinical trials for Squamous Cell Carcinoma of Head and Neck

A Study of Docetaxel for Injection (Albumin-bound) in Combination With Nivolumab in Patients With Head and Neck (SCCHN)

Start date: March 4, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This trial is a single-arm, multicenter phase Ib/II clinical study to evaluate the efficacy and safety of Docetaxel for Injection (Albumin-bound) combined with Nivolumab and the pharmacokinetic characteristics of Docetaxel in patients with recurrent or metastatic SCCHN who are positive for PD-L1 expression and have progressed on or after platinum-based therapy.

NCT ID: NCT05027100 Recruiting - Clinical trials for Small Cell Lung Cancer (SCLC)

Tislelizumab Combined With Anlotinib and 2-cycles Irinotecan as Second Line Treatment of SCLC

Start date: September 30, 2021
Phase: N/A
Study type: Interventional

SCLC has short doubling time, high proliferation rate and early widespread metastasis. Most patients with SCLC have hematogenous metastasis. SCLC is highly sensitive to initial chemoradiotherapy, but the recurrence rate is high. The strategy for local limited SCLC patients was chemotherapy plus chest radiotherapy; In patients with extensive stage SCLC, first-line platinum-based chemotherapy has been established as the standard treatment for patients with small cell lung cancer (SCLC) with better results. Although the initial response to chemotherapy is high, it is easy to relapse and develop drug resistance. In second-line therapy, the single-agent activity of multiple chemotherapy agents has been demonstrated, but a higher incidence of grade 3-4 hematological adverse events In the Passion study published by Wang Jie et al. [10], the efficacy and safety of the antiangiogenic drug apatinib combined with carrizumab in the second-line treatment of small cell lung cancer were investigated. A total of 59 patients were enrolled in the study. Of the 47 patients in the extended phase, the confirmed ORR was 34.0% (95%CI 20.9-49.3), with a median PFS of 3.6 months and a median OS of 8.4 months In patients with platinum sensitivity and platinum resistance, ORR was 37.5% vs 32.3%, MPFS was 3.6m vs 2.7m, and MOS was 9.6m vs 8.0m. Grade 3 treatment-related adverse events (TRAEs) occurred in 43 of the 59 patients (72.9%), and 5 patients (8.5%) were discontinued due to TRAEs. The combination regimen showed potential antitumor activity in both platinum-sensitive and platinum-resistant cases. The research and exploration of small cell lung cancer can learn from the research idea in the field of non-small cell lung cancer. The Checkmate9LA study reported in 2020ASCO [11] investigated the safety and efficacy of Nivolumab+2 cycle chemotherapy in first-line treatment of non-small cell lung cancer with negative driver gene. The MOS in the immunization combination group was significantly better than that in the chemotherapy group (15.6 months vs. 10.9 months, HR 0.66), and the 1-year survival rate was 63% vs. 47%, respectively. The ORR in the immunization combination group was also improved (38% vs. 25%), and the MDOR was 11.3m vs. 5.6m, which was tolerable in terms of safety. The incidence of grade 3-4 treatment-associated AE was 47% in the immune-combined group and 38% in the chemotherapy group. From the perspective of mechanism, chemotherapy can enhance the immunogenicity of tumor cells, damage the immune cell inhibitory activity, which can induce tumor cell apoptosis, expression of MHC class 1 molecules increases and mature dendritic cells to promote the immune response, in the design, add 2 cycles of chemotherapy short-term intensive treatment, make up the immune short board, For example, the early onset of slow and immune characteristic events such as large tumor load, pseudo progression, hyperrogression and other problems, to achieve the optimization and upgrading of the scheme. Based on Rationale 307, Tislelizumab was approved on January 12, 2021 for first-line treatment in combination with paclitaxel and carboplatin in patients with locally advanced or metastatic squamous non-small cell lung cancer. t the same time, Tislelizumab initial efficacy in patients with extensive small-cell lung cancr.Rational-206 study is a phase Ⅱ multi-cohort study of Tislelizumab combined with first-line platinum-containing chemotherapy in patients with advanced lung cancer in China. The MPFS in the SCLC cohort was about 7 months, and the MOS reached 15.6 months. Based on the above studies and data, in the second-line treatment of SCLC, anti-vascular targeted drugs combined with chemotherapy can obtain a certain survival benefit, especially for patients with sensitive recurrence, and the benefit is more significant. he immune checkpoint inhibitors have gradually emerged in the second-line and later treatment of SCLC, but the single drug effect has not been a great breakthrough; a small molecule antiangiogenic targeted drug in China, Anlotinib has obtained third-line and later indications of SCLC through ALTER1202 data, and has been included in the 2019 CSCO Guidelines for the Diagnosis and Treatment of Primary Lung Cancer. t the same time, it is similar to the Checkmate9LA study regimen, combined with two cycles of chemotherapy, to improve the short-term efficacy. Therefore, Anlotinib combined with Tislelizumab, a PD-1 inhibitor, and 2 cycles of Irinotecan monotherapy were tried in second-line SCLC, with the hope of breaking through the difficulties of high recurrence rate and rapid disease progression of existing second-line SCLC chemotherapy, regardless of platinum-sensitive recurrence or platinum-resistant recurrence, and providing more options for SCLC patients.

NCT ID: NCT05026489 Recruiting - Cerebral Infarction Clinical Trials

G6PD Deficiency in Infarction Patients in Shaanxi Province

GPS-IP
Start date: November 1, 2021
Phase:
Study type: Observational

Cerebral infarction brings heavy burden to patients and families with high morbidity, mortality, disability and recurrence rate. Anti-platelet aggregation therapy plays important role for secondary prevention of cerebral infarction. G6PD deficiency is a rare genetic disorder, patients with this disorder could suffer hemolysis after eating broad beans. Professor Zeng Jinsheng et al found that the hemolysis risk of G6PD deficiency patients was significantly increased when aspirin was applied in Guangdong Province. However, the prevalence of G6PD deficiency in northern China remains unknown, as well as the safety of antiplatelet therapy. To this end, 1000 patients with acute cerebral infarction will be continuously included in 30 second-level and above hospitals in 10 prefectures and cities of Shaanxi Province for observation and follow-up for 12 months, to explore the prevalence of G6PD deficiency in cerebral infarction patients in Shaanxi Province, and to analyze the relationship between G6PD deficiency and the clinical characteristics and prognosis of cerebral infarction. To clarify the efficacy and safety of antiplatelet therapy for G6PD patients with cerebral infarction is of great significance for guiding the individualized treatment of cerebral infarction.

NCT ID: NCT05026463 Recruiting - Clinical trials for Mechanical Ventilation

Use of Pressure Muscle Index to Avoid Over-assistance During Pressure Support Ventilation

Start date: September 1, 2021
Phase: N/A
Study type: Interventional

Pressure support ventilation (PSV) is the most commonly used mode in mechanical ventilated patients. Studies have shown that over-assistance was prevalent in patients undergoing PSV. Up to now, no reliable method has been recommended to select an "optimal" inspiratory support level. Pressure muscle index (PMI) was introduced recently to evaluate the degree of spontaneous breathing effort. We hypothesize that PMI might be used as an indicator for over-assistance during PSV. In this randomized crossover study, inspiratory support is set at three levels according to negative, positive and zero PMI. Inspiratory effort, work of breathing, and respiratory mechanics are compared among the three inspiratory pressure support levels.

NCT ID: NCT05026229 Recruiting - Clinical trials for Precursor Cell Lymphoblastic Leukemia-Lymphoma

A Study of Dasatinib Plus Reduced Intensive Consolidation Chemotherapy in Ph+ Adult ALL

Start date: September 6, 2021
Phase: N/A
Study type: Interventional

This project is a key clinical research project approved by the Clinical Research Center of the First Affiliated Hospital of Xi'an Jiaotong University. Tyrosine kinase inhibitors (TKI) combined with intensive chemotherapy has markedly improved the outcomes of philadelpha-positive lymphoblastic leukemia (Ph+ ALL). However, a considerable proportion of patients failed to complete the intended chemotherapy and some even died early. The optimal balance between the intensity of chemotherapy and safety should be explored. In this study, Ph+ ALL patients who achieve complete remission (CR) after VP regimen (vincristine and prednisone) plus dasatinib as induction are enrolled and then the participants will receive different consolidation chemotherapy. Patients in the group A will continue to use VP regimen plus dasatinib, while the group B receives hyper-CVAD/methotrexate-cytarabine regimen plus dasatinib. The measurable residual disease (MRD), CR, adverse effects (AE), overall survival (OS) and disease free survival (DFS) will be observed to determine the proper consolidation chemotherapy regimen.

NCT ID: NCT05025358 Recruiting - Solid Tumor Clinical Trials

A Study of LP-118 in Patients With Advanced Tumors

Start date: September 14, 2021
Phase: Phase 1
Study type: Interventional

This is a phase I, multi-center, open-label, dose escalation study to evaluate the safety, tolerability, pharmacokinetics and clinical activity of LP-118 in patients with advanced malignancies, including solid tumors and lymphomas. LP-118 is a BCL-2/BCL-XL small molecule inhibitor.