Jiang Juling, Liu Rui, Zhang Zhenhua, Zhang Xiwen, Qi Runzhi, Chen Shuntai, Zhang Xing, Xi Yupeng, Guo Qiujun, Zheng Honggang, Hua Baojin
Guang'anmen Hospital, China Academy of Chinese Medical Sciences.
China Academy of Chinese Medical Sciences.
Medicine (Baltimore). 2019 Nov;98(47):e17975. doi: 10.1097/MD.0000000000017975.
Pancreatic cancer is one of the most lethal malignancies worldwide. Most patients are diagnosed at an advanced stage, which leads to a poor prognosis and a low survival rate. At present, treatment options for pancreatic cancer are limited, so it is vital to explore new treatments and strategies. Traditional Chinese medicine (TCM) is an important method for cancer prevention and treatment in China. We will conduct a multicenter, prospective cohort study to evaluate the survival and quality of life of patients with advanced pancreatic cancer treated with integrated traditional Chinese and Western medicine, further refine the core pathogenesis of TCM for pancreatic cancer, form a core prescription, and provide clinical data support for the clinical plan of integrated treatment of pancreatic cancer using Chinese and Western medicine; this will aid in the development of the best comprehensive treatment plan for patients.
This study will recruit patients with stage 3 to 4 pancreatic cancer in 12 medical units from April 2019 to June 2020. Patients will be divided into a Western medicine treatment group and an integrated traditional Chinese and Western medicine treatment group, with a total of 148 patients. Overall survival is the main efficacy index, while the secondary efficacy indexes are progression-free survival, tumor markers, TCM symptom grading scale, quality of life assessment, Eastern Cooperative Oncology Group (ECOG) score, and imaging assessment. A follow-up will be performed every 6 weeks ±1 week. The end point is the death of the patient or the end of the study (October 31, 2021). Statistical analysis will be performed using Statistical Packages of Social Sciences software (SPSS).
This work was supported by Beijing Municipal Science and Technology Commission and approved by the ethics committee of Guang'anmen Hospital, China Academy of Chinese Medical Sciences (Approval No. 2019-016-KY). All patients will sign a written informed consent prior to data collection. The results will be disseminated through peer-reviewed journals and conference presentations and will be openly shared after completion of the trial.
The trial was registered with the Chinese Clinical Trials Registry (ChiCTR1900022632, pre-registration).
胰腺癌是全球最致命的恶性肿瘤之一。大多数患者在晚期才被诊断出来，这导致预后不良和生存率较低。目前，胰腺癌的治疗选择有限，因此探索新的治疗方法和策略至关重要。中医是中国癌症防治的重要方法。我们将开展一项多中心、前瞻性队列研究，以评估中西医结合治疗晚期胰腺癌患者的生存情况和生活质量，进一步细化胰腺癌的中医核心病机，形成核心处方，并为中西医结合治疗胰腺癌的临床方案提供临床数据支持；这将有助于为患者制定最佳综合治疗方案。
本研究将于2019年4月至2020年6月在12个医疗单位招募3至4期胰腺癌患者。患者将被分为西医治疗组和中西医结合治疗组，共148例患者。总生存期是主要疗效指标，次要疗效指标包括无进展生存期、肿瘤标志物、中医症状分级量表、生活质量评估、东部肿瘤协作组（ECOG）评分和影像学评估。每6周±1周进行一次随访。终点是患者死亡或研究结束（2021年10月31日）。将使用社会科学统计软件包（SPSS）进行统计分析。
本研究得到北京市科学技术委员会的支持，并获得中国中医科学院广安门医院伦理委员会批准（批准号：2019-016-KY）。所有患者在数据收集前将签署书面知情同意书。研究结果将通过同行评审期刊和会议报告进行传播，并在试验完成后公开分享。
该试验已在中国临床试验注册中心注册（ChiCTR1900022632，预注册）。
