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CLINICAL TRIAL article
Front. Oncol.
Sec. Gastrointestinal Cancers: Gastric and Esophageal Cancers
Volume 15 - 2025 | doi: 10.3389/fonc.2025.1478390
Qizhu Yuling Prescription in the Prevention of Postoperative Metastasis and Recurrence of Esophagus Cancer: study protocol for a randomized, double-blind, placebo-controlled, multicenter clinical trial
Provisionally accepted
Miao Kong 1
Bowen Xu 1,2
Zhu Guanghui 1
Xin-miao Wang 1 Ziyu Kuang 1,3
Qianhui Sun 1,4 Kexin Liu 3
Zilin Wang 1,3
Ying Zhang 1*
Li Jie 1*- 1 Department of Oncology, Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, Beijing Municipality, China
- 2 Department of TCM/integrative medicine, Hunan Cancer Hospital, Changsha, China
- 3 Graduate School of Beijing University of Chinese Medicine, Beijing, China
- 4 Department of Oncology, The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, Zhejiang Province, China
Background: Esophageal cancer (EC) is a malignant tumor with a high recurrence and metastasis rate and poor prognosis. In 2024, China ranked first in the world in terms of new EC cases and deaths. Surgery is the main treatment method for EC, but the clinical difficulty is how to prevent recurrence and metastasis after surgery. Traditional Chinese medicine as a complementary therapy has played an important role in this regard. Preclinical studies have confirmed that Qizhu Yuling Prescription (QZYLP) has anticancer effects, reduces treatment side effects, and improves quality of life, except for the lack of long-term prognostic results. Therefore, this study aims to investigate whether QZYLP can reduce the recurrence and metastasis rates of EC after surgery, improve diseasefree survival (DFS), prolong overall survival, and observe the safety of the drug.Methods: This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial. It seeks to enroll 310 patients from 10 hospitals who have completed adjuvant therapy following R0 surgery for esophageal squamous cell carcinoma without recurrent metastasis. Using a centerrandomized design, participants will be assigned to the control group (n=155, receiving placebo treatment) or experimental group (n=155, receiving QZYLP granules treatment). Treatment will last for 6 months, with follow-up every 3 months after the final treatment or endpoint event, continuing for up to 3 years postoperatively. The primary outcome measured is DFS at 1 year postoperatively. Secondary outcomes included indicators related to prognosis, fat distribution, peripheral blood inflammation, tumor markers, and quality of life scales.Discussion: This study aims to further clarify the efficacy and safety of QZYLP in preventing postoperative recurrence and metastasis of EC, and to explore the mechanism of action. The results of this study will provide high-quality evidence for the participation of TCM in the comprehensive treatment program of EC, and improve the precise diagnosis and treatment system of TCM in EC.
Keywords: Qizhu Yuling Prescription, esophageal cancer, Traditional Chinese Medicine, randomized controlled trial, Disease-Free Survival, protocol Trial registration: ClinicalTrials.gov No. NCT05626309
Received: 09 Aug 2024; Accepted: 28 Feb 2025.
Copyright: © 2025 Kong, Xu, Guanghui, Wang, Kuang, Sun, Liu, Wang, Zhang and Jie. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Ying Zhang, Department of Oncology, Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, Beijing Municipality, China
Li Jie, Department of Oncology, Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, Beijing Municipality, China
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