NCT03578575|UnknownPhase 2DMC
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Sponsor study identifier
interventional
120
1 country
1
Study Start
July 26, 2018
Actual (reported)Primary Completion
July 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
To investigate the molecular mechanism of traditional Chinese medicine constitution, the investigators proposed a randomized, double-blind, placebo-controlled, phase II trial to recruit 120 patients with nasopharyngeal cancer. Next generation sequencing, immune repertoire, gut microbiota, traditional Chinese medicine constitution and tongue diagnosis would be examined before/after 16 weeks of treatment of Danggui Buxue Tang from the beginning of concurrent chemoradiotherapy in this project. The correlation between different examinations would be analyzed to investigate the molecular mechanism of traditional Chinese medicine constitution. Disease survival, recurrence, and quality of life would be also followed up for two years to evaluate the benefit of Danggui BuxueTang.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 16, 2018
Actual (reported)July 6, 2018
Actual (reported)July 26, 2018
Actual (reported)July 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The correlation between next-generation sequencing analysis and traditional Chinese medicine constitution
Identification of biomarkers by next-generation sequencing analysis in nasopharyngeal cancer patients.
The biomarker as assessed by Next-generation sequencing analysis, Change from baseline in the gene expression at 16 weeks of treatment of Danggui Buxue Tang from the beginning of concurrent chemoradiotherapy and 2-year follow-up.
The quality of life as assessed by the score of questionnaire of European Organisation for Research and Treatment of Cancer C30
Change from baseline in score of questionnaire at 16 weeks of treatment of Danggui Buxue Tang from the beginning of concurrent chemoradiotherapy and 2-year follow-up.
The quality of life as assessed by the score of questionnaire of European Organisation for Research and Treatment of Cancer H&N35
Change from baseline in score of questionnaire at 16 weeks of treatment of Danggui Buxue Tang from the beginning of concurrent chemoradiotherapy and 2-year follow-up.
Survival rate
throughout the study, an average of 2 year
Disease recurrence
throughout the study, an average of 2 year
Next-generation sequencing
pre-treatment and after 16 weeks of treatment
Use Danggui Buxue Tang 5g/time, 3 times a day, for 12 weeks.
Use Placebo 5g/time, 3 times a day, for 12 weeks.
Danggui Buxue Tang is an extracted powder of traditional Chinese medicine formula.
Placebo is a very low dose Danggui Buxue Tang powder.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
China Medical University Hospital
Taichung, 404, Taiwan
Hsieh HY, Yang SN, Lien MY, Wang YC, Chang CH, Wu HK, Hsu YC, Hsieh CY, Huang YC, Chang HH. Combination of Danggui Buxue Tang and concurrent chemoradiotherapy improves treatment outcomes by strengthening B cell immunity in patients with nasopharyngeal carcinoma-a double-blind, randomized trial. Transl Cancer Res. 2025 Sep 30;14(9):5199-5210. doi: 10.21037/tcr-2025-406. Epub 2025 Sep 26.
Hen-Hong Chang, Ph.D.
China Medical University, China
Han-Kuei Wu, Ph.D.
China Medical University, China
Kun San Chao, M.D.
China Medical University, China
Eric Y. Chuang, Ph.D.
National Taiwan University
First Submitted
May 16, 2018
First Posted
July 6, 2018
Study Start
July 26, 2018
Actual (reported)Primary Completion
SHR-1210 in Recurrent/Metastatic Nasopharyngeal Carcinoma Who Have Received Previous At Least Two Lines of Chemotherapy.
Nivolumab + Chemoradiation in Stage II-IVB Nasopharyngeal Carcinoma (NPC)
Contact the study team to confirm eligibility.
Ming-Hsui Tsai, M.D.
China Medical University, China
Yu-Chuen Huang, Ph.D.
China Medical University, China
Chia-Hao Chang, M.M.S.
China Medical University, China
Yao-Ching Wang, M.M.S.
China Medical University, China
Chun-Hung Hua, M.D.
China Medical University, China
Shih-Neng Yang, M.D.
China Medical University, China
Ying-Chun Lin, M.D.
China Medical University, China
Ti-Hao Wang, M.D.
China Medical University, China
Ching Yun Hsieh, M.D.
China Medical University, China
Ming-Yu Lien, M.D.
China Medical University, China
July 31, 2020
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 30, 2018
Record last verified: 2018-07
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Source: ClinicalTrials.gov.
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