Clinical Trials Study
Copyright ©The Author(s) 2017. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Oncol. Apr 10, 2017; 8(2): 158-167
Published online Apr 10, 2017. doi: 10.5306/wjco.v8.i2.158
Study of recombinant human interleukin-12 for treatment of complications after radiotherapy for tumor patients
Na Guo, Wen-Qin Wang, Xiao-Jing Gong, Lei Gao, Li-Rong Yang, Wei-Na Yu, Hong-Yu Shen, Ling-Qin Wan, Xi-Feng Jia, Yi-Shan Wang, Yi Zhao
Na Guo, Xiao-Jing Gong, Lei Gao, Li-Rong Yang, Wei-Na Yu, Hong-Yu Shen, Ling-Qin Wan, Xi-Feng Jia, Yi-Shan Wang, Center for Tumor Treatment, People’s Liberation Army 107th Hospital, Yantai 264002, Shandong Province, China
Wen-Qin Wang, Academy of Military Medical Sciences, Sanatorium for Retired Cadres, Beijing 100039, China
Yi Zhao, Kang Litai Pharmaceutical Co. Ltd., Qingdao 266001, Shandong Province, China
Author contributions: Wang YS and Zhao Y contributed to the conception of the study; Guo N and Wang WQ contributed significantly to analysis and manuscript preparation; Guo N, Gao L and Shen HY performed the data analyses and wrote the manuscript; Wang WQ and Gong XJ helped perform the analysis with constructive discussions; Yang LR and Yu WN collected specimens and detected indexes; all the authors contributed to this article.
Institutional review board statement: This study was reviewed and approved by the scientific ethical committee of the Hospital. All operations were performed according to international guidelines concerning the care and treatment of cancer patients.
Informed consent statement: Patients were informed of the purpose of the experiment and agreed to treatment with rhuIL-12. Informed consent was obtained in all cases, and protocols were approved by the scientific ethical committee of the Hospital.
Conflict-of-interest statement: The authors declare no conflicts of interest.
Data sharing statement: No additional unpublished data are available.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See:
Correspondence to: Dr. Yi-Shan Wang, Center for Tumor Treatment, People’s Liberation Army 107th Hospital, 7 Zhichu South Road, Yantai 264002, Shandong Province, China.
Telephone: +86-535-2933528 Fax: +86-535-2933500
Received: October 11, 2016
Peer-review started: October 14, 2016
First decision: November 14, 2016
Revised: December 14, 2016
Accepted: January 2, 2017
Article in press: January 4, 2017
Published online: April 10, 2017

To evaluate the treatment effects of recombinant human interleukin-12 (rhIL-12) on radiotherapy complications, such as severe myelosuppression or pancytopenia, the decline or imbalance of immune function, etc.


The patients received high-dose and short-course precise radiotherapy, such as Cyber knife and image-guided radiotherapy (IGRT), which can cause myelosuppression or pancytopenia and immune function decline within a short time. One-hundred subjects were enrolled in the study, and 50 were randomized to a treatment group which used rhIL-12 and 50 were randomized to a control group which used symptomatic and supportive therapy after radiotherapy. The 50 subjects in the treatment group were further divided into five subgroups and intervened with rhIL-12 at a dose of 50, 100, 150, 200 or 250 ng/kg respectively. The dose-effect relationship was observed.


RhIL-12 significantly attenuated the decrease of peripheral blood cells in the treatment group, and immune function was improved after treatment. Due to the different radiation doses, there was a fluctuation within 12 h after treatment but mostly showing an increasing trend. As to the clinical manifestations, 2 patients in the 250 ng/kg subgroup showed low fever after administration, 1 patient in the 200 ng/kg subgroup and 2 patients in the 250 ng/kg subgroup showed mild impairment of liver function during the observation period.


RhIL-12 has effective therapeutic and protective effects on complications following radiotherapy, such as the decline of blood cells, myelosuppression and the decline or imbalance of immune function, which indicated good prospects for development and application.

Keywords: Recombinant human interleukin-12, Cancer prevention, Radiotherapy complications, Clinical research

Core tip: Recombinant human interleukin-12 (rhIL-12) is a new kind of biological agent secreted by Chinese hamster ovary cells. Study has shown that it has the advantage of promoting recovery of hematopoietic function, regulating the body’s immunity and inhibiting angiogenesis growth. At present, the research of rhIL-12 stays in the foundational realm and in animal experimentation. In our study, however, there were 100 patients with large or numerous tumors (more than two) and who received precision radiotherapy (Cyber knife or image-guided radiotherapy). The results showed that rhIL-12 can prevent radiation damage, improve hematopoietic function, regulate immunity, reduce the side effect of radiotherapy and improve the quality of life of patients.