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NCT ID: NCT05229315 Recruiting - Clinical trials for Nasopharyngeal Carcinoma

PD-1 Combined With Intensity Modulated Radiation Therapy in the Treatment of Intermediate-risk Nasopharyngeal Carcinoma

Start date: March 12, 2022
Phase: Phase 2
Study type: Interventional

To evaluate the safety and efficacy of PD-1 immune checkpoint inhibitor combined with intensity modulated radiation therapy in the treatment of intermediate-risk nasopharyngeal carcinoma (T2-3N0 or T1-2N1 stage and EBV-DNA≤4000 copy/ml).

NCT ID: NCT05229133 Recruiting - Myopic Astigmatism Clinical Trials

Efficacy and Safety of CLEAR in Myopia and Astigmatism in Chinese Population

Start date: November 29, 2021
Phase: N/A
Study type: Interventional

In this multicenter, prospective, interventional, single-arm clinical trial, the aim is to determine safety and efficacy of CLEAR using the FEMTO LDV Z8 in Chinese patients in China. The primary objective is to evaluate the visual outcome after CLEAR using the FEMTO LDV Z8 in myopia and astigmatic myopia at the time point, when stability of manifest refraction spherical equivalent (MRSE) is reached. The corresponding hypothesis is that the percentage of treated eyes with satisfactory Uncorrected Distance Visual Acuity (UCDVA) at the point when stability of MRSE is reached after CLEAR is at least 85% of all treated eyes. This hypothesis has been chosen in line with the recommendations of the "Checklist of Information Usually Submitted in an Investigational Device Exemptions (IDE) Application for Refractive Surgery Lasers" issued by the FDA. The secondary objectives are to evaluate the efficacy and safety with respect to stability, predictability, device defects and adverse events of CLEAR using the FEMTO LDV Z8 in myopia and astigmatic myopia during follow-up.

NCT ID: NCT05229003 Recruiting - Clinical trials for Metastatic Colorectal Cancer

Irinotecan Plus Anlotinib or Further in Combination With Penpulimab for Second-line Treatment of mCRC

Start date: March 9, 2022
Phase: Phase 2
Study type: Interventional

This is an exploratory, non-controlled, multi-cohort, phase II small-sample clinical study designed to evaluate the clinical benefit of second-line treatment with anlotinib plus irinotecan or further in combination with a PD-1 monoclonal antibody (penpulimab) in patients with advanced colorectal cancer after first-line treatment failure. To explore the rationality of the combination of chemotherapy and targeted therapy and immunotherapy strategy and obtain relevant survival and safety data. The study will fully evaluate the efficacy, PFS, OS, safety and related biomarkers of the regimen.

NCT ID: NCT05228990 Recruiting - Fibromyalgia Clinical Trials

Pilot Study of Warm Acupuncture in Treatment of Cold-sensitive Fibromyalgia Syndrome

Start date: February 14, 2022
Phase: N/A
Study type: Interventional

Non-pharmaceutical therapies, such as acupuncture, hydrotherapy, and meditative exercises (such as Qigong (including Tai Chi and Ba-Duan-Jin), have been shown to reduce pain and improve physical function. The management recommendations of fibromyalgia issued by the European Union, Canada, Germany and Israel have all affirmed the "first-line" role of Non-pharmaceutical therapy. Because of its good efficacy and safety, acupuncture therapy has been recommended in the management guidelines and has broad application prospects. Warm acupuncture is a therapy combining acupuncture and moxibustion, which is widely used in the treatment of various painful diseases in China, especially for cold-sensitive patients . This study aims to observe the safety and effectiveness of warm acupuncture in the treatment of cold-sensitive fibromyalgia patients, in order to provide a more alternative non-drug therapy for this particular type of patients with fibromyalgia .

NCT ID: NCT05228951 Recruiting - Breast Cancer Clinical Trials

Pyrotinib Maleate, Trastuzumab, SHR6390 and Letrozole in Combination for Stage II-III TPBC

Start date: February 10, 2022
Phase: Phase 2
Study type: Interventional

NOAH study confirmed that trastuzumab combined with chemotherapy can significantly improve PCR compared with chemotherapy alone, and established the status of trastuzumab as a new adjuvant targeted therapy. The emergence of CDK4/6 inhibitors has brought hope to breast cancer patients resistant to endocrine therapy. studies have shown that pyrotinib maleate combined with CDK4/6 inhibitor can significantly inhibit the proliferation of HER2 positive breast cancer cell lines, reduce the activation of pAKT and pHER3, inhibit cell arrest in G0-G1 phase, and increase cell apoptosis. In the mouse model, pyrotinib maleate combined with CDK4/6 inhibitor exhibits higher anti-tumor activity than any anti-tumor drug alone. Moreover, the toxicity of the combined therapy does not increase compared with monotherapy. This provides a good preclinical model for the treatment of breast cancer by pyrotinib maleate combined with CDK4/6 inhibitor. In addition, NeoALTTO study、CALGB 40601 study、NSABP B-41 study confirmed that the clinical efficacy of lapatinib combined with trastuzumab combined chemotherapy was better than that of lapatinib or trastuzumab single target treatment group. Therefore, it is envisaged that the combination of pyrotinib maleate and dalpiciclib combined with letrozole on the basis of adding new trastuzumab to treat triple positive breast cancer will further improve the curative effect. In conclusion, we believe that pyrotinib maleate combined with trastuzumab, dalpiciclib and letrozole can provide better strategies for neoadjuvant therapy in patients with II-III three positive breast cancer.

NCT ID: NCT05228743 Recruiting - Gastric Cancer Clinical Trials

Conversion Therapy of Hyperthermic Intraperitoneal Chemotherapy Plus Chemotherapy and Chemotherapy in Stage IV Gastric Cancer

Start date: September 1, 2020
Phase: N/A
Study type: Interventional

The main purpose of this study is to compare Hyperthermic Intraperitoneal Chemotherapy combined with Chemotherapy and Chemotherapy as a conversion therapy for gastric Cancer Patients with peritoneal metastasis in Safety and Effectiveness.

NCT ID: NCT05228483 Recruiting - Clinical trials for Vulva Lichen Sclerosus

Carbon Dioxide(CO2)Fractional Laser Plus Photodynamic Therapy in Female Patients With Vulvar Lichen Sclerosus

Start date: November 23, 2021
Phase: N/A
Study type: Interventional

The objective of this study is to evaluate the safety and efficacy of CO2 fractional laser combined with photodynamic therapy in female patients with vulvar lichen sclerosus.

NCT ID: NCT05228431 Recruiting - Clinical trials for Advanced Rectal Cancer

Modified Sandwich Therapeutic Regimen for Locally Advanced Rectal Cancer

Start date: March 2, 2022
Phase: Phase 2
Study type: Interventional

In the treatment of locally advanced rectal cancer, the short-term and long-term efficacy of the traditional sandwich regimen has not reached satisfactory efficacy. For this reason, the concept of reducing the dose of postoperative chemotherapy or directly moving forward the full amount of postoperative chemotherapy was proposed, which is called total neoadjuvant therapy (TNT). However, TNT also includes the high toxicity of oxaliplatin in the whole process and the long time interval between the end of radiotherapy and the operation, which leads to fibrosis of the surrounding tissue, which increases the difficulty of surgical resection and makes it difficult to ensure good surgical specimen quality. In addition to this, there are issues that may increase the risk of potential disease progression in patients with poor treatment withdrawal. Therefore, appropriately reducing the intensity of chemotherapy and controlling the total duration of preoperative neoadjuvant therapy during radiotherapy is expected to alleviate the side effects of neoadjuvant therapy. Here, the investigators synthesized the characteristics of TNT and sandwich regimens and proposed a XELOX regimen and capecitabine alternate administration combined with preoperative intensity modulated radiation therapy.

NCT ID: NCT05228119 Recruiting - Clinical trials for Advanced Solid Tumor

A Study of Oncolytic Virus Injection (RT-01) in Combination With PD-1 Inhibitor in Patients With Advanced Solid Tumors

Start date: January 4, 2022
Phase: Phase 1
Study type: Interventional

This is a single-arm, open-label, exploratory study to evaluate safety and efficacy of oncolytic virus injection(RT-01) in combination with PD-1 inhibitor (Nivolumab) in patients with advanced solid tumors. The purpose of this study is to evaluate the safety and tolerability, antitumor activity, The immunoreactivity, The immunogenicity, pharmacokinetics and virus shedding of RT-01 in combination with PD-1 inhibitor.

NCT ID: NCT05228093 Recruiting - Clinical trials for Nasopharyngeal Carcinoma, Postradiation, Necrosis, Endoscopy Surgery, Conservative Treatment

A Randomized Controlled Clinical Trial of Surgery Versus Conservative Treatment for Mild and Moderate-grade Nasopharyngeal Necrosis

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

Post radiation nasopharyngeal necrosis is a relatively special radiotherapy sequelae after radiotherapy for nasopharyngeal carcinoma. According to the degree of its development, it can be roughly divided into three stages: mild, moderate and severe stages, corresponding to the pre-nasopharyngeal necrosis stage, the soft tissue necrosis stage and the bone necrosis stage respectively. In the past, treatment methods were limited, including anti-infection, topical nasopharyngeal drugs, etc., the efficacy was not good, the nasopharyngeal necrosis lesions progressed, and a series of serious complications occurred, such as: intracranial infection secondary to osteonecrosis, massive nasopharyngeal hemorrhage, etc. It seriously endanger the life of the patient. With the continuous development of medical technology, the means of treatment are also constantly updated, such as repeated debridement guided by nasal endoscope, modified nasopharyngeal irrigation and hyperbaric oxygen therapy, the healing rate of nasopharyngeal necrosis has improved, especially the cure rate of patients in the mild and moderate-stages can reach 54.1%-54.8%. However, there are still some patients with poor healing of nasopharyngeal wounds after treatment. Since 2004, our team has carried out a series of studies such as transnasal endoscopic nasopharyngeal resection combined with posterior pedicle nasal septum and floor mucoperiosteum flap(NSFF), and successfully achieved minimally invasive and en bloc resection of localized recurrent nasopharyngeal carcinoma. This method basically solved the problem of surgical wound healing of recurrent nasopharyngeal carcinoma. On this basis, we further applied it to the treatment of nasopharyngeal necrosis to further improve the cure rate and improve the prognosis. In addition, our retrospective study showed that compared with conservative treatment, curative-intent endoscopic necrectomy followed by reconstruction using the posterior pedicle nasal septum and floor mucoperiosteum flap can effectively prolong the overall survival time of patients and significantly improve the symptoms, but it still needs to be further confirmed by prospective clinical trials. In addition, some patients (22.2%) had necrosis of the mucosal flap after receiving surgery, which affected the healing of surgical wounds. Besides, the development of nasopharyngeal necrosis is a slow process. If nasopharyngeal necrosis removal combined with pedicled mucosal flap repair is performed prematurely, the area outside the operation area may be necrotic again. Theoretically, each patient only has the nasal septum-nasal septum mucosal flaps on both sides of the nasal septum, which means that each patient only has 2 chances of repairing the nasal septum-nasal floor mucosal flaps. Premature surgical intervention may not only lead to incomplete debridement, but also lose a valuable opportunity for mucosal flap repair. Therefore, based on the above problems, this study intends to compare the endoscopic nasopharyngeal necrosis debridement combined with pedicled mucosal flap repair versus the best conservative regimen for the treatment of early and mid-stage nasopharyngeal necrosis, to explore the prognosis of patients with nasopharyngeal necrosis. The preferred regimen, if confirmed by this study, is expected to standardize the treatment of nasopharyngeal necrosis after radiotherapy and further promote it, effectively increasing the cure rate of nasopharyngeal necrosis and improving the prognosis of patients.