Clinical Trials of Liposomes in Children’s Anticancer Therapy: A Comprehensive Analysis of Trials Registered on ClinicalTrials.gov

Abstract

Zhaosong Feng,1 Yuyang Gu,2 Mengping Yuan,3 Renzhong Xiao,4 Zhenghua Fei2 1Pharmacy Department, Jianhu People’s Hospital, Jianhu, Jiangsu Province, 224700, People’s Republic of China; 2Department of Oncology, the First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang Province, 325000, People’s Republic of China; 3Department of Gastroenterology, the Second Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang Province, 325000, People’s Republic of China; 4R&D Center, Hunan Royal Pharmaceutical Technology Co., Ltd., Changsha, Hunan Province, 410000, People’s Republic of ChinaCorrespondence: Renzhong Xiao, R&D Center, Hunan Royal Pharmaceutical Technology Co., Ltd., Changsha City, Hunan Province, 410000, People’s Republic of China, Email [email protected] Zhenghua Fei, Department of Oncology, the First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang Province, 325000, People’s Republic of China, Email [email protected]: Clinical trials have become essential for driving the development of medicine. However, little is known about the current status of clinical trials on liposomes in children’s anticancer therapy (LCAT). This study aimed to synthesize current finding from clinical trials of LCAT in ClinicalTrials.gov.Methods: A cross-sectional descriptive study of clinical trials on LCAT was conducted, using studies registered on ClinicalTrials.gov through December 30, 2021.Results: A total of 74 eligible trials were identified, accounting for 4.8% (74/1552) of all trials on liposomes for cancer therapy. Among these trials, 70 (94.6%) were interventional trials, and the remaining 4 (5.4%) were observational trials. Of the 70 interventional trials, 63 (90.0%) were for treatment, 48.6% were involving unlabeled allocations, 30.0% were randomized, 52.9% were single group assignment, 71.4% were without masking, 28.6% were Phase 3 trials, 30.0% were Phase 1 trials, and 24.3% were Phase 2 trials. Furthermore, 17 liposomal drugs for 123 types of cancer were investigated in the interventional trials, and these were mainly focused on organic chemicals (43/70, 61.4%). Of these cancers, the highest proportion was leukemia (15.4%), followed by lymphoma (9.8%) and ovarian cancer (8.9%).Conclusion: High quality, adequately powered, masked, appropriately sized, and randomized clinical trials represent the critical priorities for conducting a high-quality clinical trial. However, most of these trials for LCAT were non-randomized, single group assignment, and non-blinded interventional trials of small scale, with various eligibility criteria and outcome measures. Our analysis highlights the need for improvement in the completeness of study designs curated on clinicalTrials.gov. We urge for decision-makers to avoid adopting entrenched positions about the study design of cancer clinical trials to avoid this problem. As such, tackling the problematic challenges related to cancer and designing efficient trials for cancer requires developing and applying new approaches and multiple strategies.Keywords: liposomes, liposomal drug, cancer, children anticancer therapy, clinical trials

Keywords

• liposomes
• liposomal drug
• cancer
• children anticancer therapy
• clinical trials