Thalidomide for refractory hemorrhagic chronic radiation proctitis secondary to pelvic malignancy radiotherapy: A phase II clinical trial

doi:10.3748/wjg.v32.i14.116529

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Apr 14, 2026 (publication date) through Apr 3, 2026

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World Journal of Gastroenterology

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1007-9327

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Copyright: ©Author(s) 2026. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution-NonCommercial (CC BY-NC 4.0) license. No commercial re-use. See permissions. Published by Baishideng Publishing Group Inc.

World J Gastroenterol. Apr 14, 2026; 32(14): 116529
Published online Apr 14, 2026. doi: 10.3748/wjg.v32.i14.116529

Thalidomide for refractory hemorrhagic chronic radiation proctitis secondary to pelvic malignancy radiotherapy: A phase II clinical trial

Xiao-Yan Huang, Qing-Hua Zhong, Ying-Yi Kuang, Zhi-Jie Li, Bin-Jie Huang, Yan-Jiong He, Miao-Miao Zhu, Qi Guan, Xiao-Yan Li, Qi-Yuan Qin, Teng-Hui Ma

Xiao-Yan Huang, Xiao-Yan Li, Department of Pharmacy, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou 510655, Guangdong Province, China

Xiao-Yan Huang, Qing-Hua Zhong, Ying-Yi Kuang, Zhi-Jie Li, Bin-Jie Huang, Yan-Jiong He, Miao-Miao Zhu, Qi Guan, Xiao-Yan Li, Qi-Yuan Qin, Teng-Hui Ma, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou 510655, Guangdong Province, China

Xiao-Yan Huang, Qing-Hua Zhong, Ying-Yi Kuang, Zhi-Jie Li, Bin-Jie Huang, Yan-Jiong He, Miao-Miao Zhu, Qi Guan, Xiao-Yan Li, Qi-Yuan Qin, Teng-Hui Ma, Biomedical Innovation Center, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou 510655, Guangdong Province, China

Qing-Hua Zhong, Department of Endoscopic Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou 510655, Guangdong Province, China

Ying-Yi Kuang, Zhi-Jie Li, Bin-Jie Huang, Yan-Jiong He, Miao-Miao Zhu, Qi Guan, Qi-Yuan Qin, Teng-Hui Ma, Department of Colorectal Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou 510655, Guangdong Province, China

Teng-Hui Ma, Department of Clinical Nutrition, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou 510655, Guangdong Province, China

Co-first authors: Xiao-Yan Huang and Qing-Hua Zhong.

Co-corresponding authors: Qi-Yuan Qin and Teng-Hui Ma.

Author contributions: Huang XY and Zhong QH contributed equally as co-first authors; Ma TH, Qin QY, Li XY, and Huang XY conceived the idea and designed the study; Huang XY, Zhong QH, Kuang YY, Li ZJ, Huang BJ, He YJ, Zhu MM, and Guan Q collected the data and followed the patients; Huang XY, Zhong QH, Kuang YY, Ma TH, Qin QY, and Li XY analyzed and interpreted the data; Huang XY, Zhong QH, and Kuang YY drafted the manuscript; Ma TH, Qin QY, and Li XY supervised the study, performed validation, and revised the manuscript; Ma TH and Qin QY made equal contributions as co-corresponding authors. All authors have read and approve the final manuscript.

Supported by Clinical Research 1010 Program of the Sixth Affiliated Hospital of Sun Yat-sen University, No. 1010CG(2022)-09; Guangdong Provincial Hospital Pharmaceutical Research Foundation, No. 2021A07; Hospital Pharmaceutical Research Foundation of Guangdong Hospital Association, No. YXKY202212; China International Medical Foundation, No. Z-2021-46-2101-2023; and Program of Guangdong Provincial Clinical Research Center for Digestive Diseases, No. 2020B1111170004.

Institutional review board statement: The study was reviewed and approved by the Ethical Committee of the Sixth Affiliated Hospital of Sun Yat-sen University, No. 2020ZSLYEC-207.

Clinical trial registration statement: This was a single-arm, open-label, single-center, phase II clinical trial registered at https://clinicaltrials.gov (NCT04680195).

Informed consent statement: All enrolled patients provided informed consent prior to receiving treatment.

Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.

CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.

Data sharing statement: The anonymised patient datasets created and/or analysed for the current study are available from the corresponding author on reasonable request.

Corresponding author: Teng-Hui Ma, Department of Colorectal Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University, No. 26 Yuancun Erheng Road, Guangzhou 510655, Guangdong Province, China. matengh@mail.sysu.edu.cn

Received: November 14, 2025
Revised: December 19, 2025
Accepted: February 3, 2026
Published online: April 14, 2026
Processing time: 141 Days and 1.8 Hours

Core Tip

Core Tip: Chronic radiation proctitis (CRP) is a common complication of pelvic radiotherapy. Its most frequent symptom is hematochezia, which is often persistent and irreversible. However, the availability of oral drug treatments for hemorrhagic CRP are still extremely limited. This single-arm, open-label, phase II clinical trial investigated the therapeutic efficacy and safety of thalidomide for refractory hemorrhagic CRP. The results demonstrated that thalidomide achieved a hematochezia remission rate of up to 83.9%, with only mild or moderate adverse events. In summary, thalidomide appears to be an effective and well-tolerated treatment option for hemorrhagic CRP.