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Inactive Indication- |
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.Singapore |
First Approval Date27 Sep 2022 |
/ Not yet recruitingPhase 4IIT Safety and Efficacy of Realgar-Indigo Naturalis Formula?RIF? Combined With Anlotinib in the Treatment of Patients With Advanced Recurrent Platinum-Resistant Ovarian Cancer: A Prospective, Multicenter Clinical Study
This project plans to conduct a prospective, multicenter clinical study. The intended participants are patients with histologically confirmed advanced (FIGO III/IV stage) ovarian serous carcinoma, ovarian endometrioid carcinoma, primary peritoneal carcinoma, or fallopian tube carcinoma who have platinum-resistant recurrence or are platinum-refractory (n=30). The study design is a single-arm study. The treatment regimen for the study group is the RIF combined with anlotinib group, with continuous administration until disease progression, death, intolerable toxicity, loss to follow-up, withdrawal of informed consent, or study termination, whichever occurs first. The treatment duration will not exceed 18 months, with a follow-up period of 24 months.
The primary endpoint is progression-free survival (PFS). Secondary endpoints include overall survival (OS), objective response rate (ORR), disease control rate (DCR), quality of life score (QOL), and safety. The primary efficacy evaluation will use imaging methods (RECIST 1.1) combined with tumor marker CA125 levels.
All data in this study will be summarized using appropriate statistical measures based on data type: continuous data will be described using mean, standard deviation (STD), median, minimum, and maximum, while categorical data will be summarized using frequency and percentage (proportion). Time-to-event data will be analyzed using the Kaplan-Meier (KM) product-limit method to estimate median survival time, with survival curves plotted and 95% confidence intervals for median time estimated when necessary.
This study aims to evaluate the efficacy and safety of RIF combined with anlotinib in patients with platinum-resistant recurrent ovarian cancer, providing a new therapeutic strategy.
评价复方银花解毒颗粒治疗儿童流行性感冒(风热证)的有效性和安全性的随机、双盲、安慰剂平行对照、多中心Ⅲ期临床试验
[Translation] A randomized, double-blind, placebo-controlled, multicenter phase III clinical trial to evaluate the efficacy and safety of compound Yinhua Jiedu granules in the treatment of influenza (wind-heat syndrome) in children
(1)确证评价复方银花解毒颗粒治疗儿童流行性感冒缩短病程及缩短热程、缓解症状、改善中医证候作用。(2)观察复方银花解毒颗粒临床应用的安全性。
[Translation] (1) To confirm and evaluate the efficacy of Compound Yinhua Jiedu Granules in shortening the course of illness and fever, relieving symptoms, and improving TCM syndromes in the treatment of influenza in children. (2) To observe the safety of Compound Yinhua Jiedu Granules in clinical application.
评价复方银花解毒颗粒治疗儿童流行性感冒(风热证)的有效性和安全性的随机、双盲、安慰剂平行对照、多中心Ⅱ期临床试验
[Translation] A randomized, double-blind, placebo-controlled, multicenter phase II clinical trial to evaluate the efficacy and safety of compound Yinhua Jiedu granules in the treatment of influenza (wind-heat syndrome) in children
主要目的:
初步评价复方银花解毒颗粒治疗儿童流行性感冒(风热证)的有效性。
次要目的:
初步评价复方银花解毒颗粒治疗儿童流行性感冒(风热证)的安全性。
[Translation] Main purpose:
To preliminarily evaluate the effectiveness of Compound Yinhua Jiedu Granules in treating influenza (wind-heat syndrome) in children.
Secondary purpose:
To preliminarily evaluate the safety of Compound Yinhua Jiedu Granules in treating influenza (wind-heat syndrome) in children.
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