PD-1 Antibody Versus Best Supportive Care After Chemoradiation in Locoregionally Advanced Nasopharyngeal Carcinoma
NCT ID: NCT03427827
Last Updated: 2024-04-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
450 participants
INTERVENTIONAL
2018-07-02
2026-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Adjuvant PD-1 antibody arm
Patients randomized to this arm will receive PD-1 antibody (SHR-1210), 200mg, ivdrip (\>30 minutes), d1, q3w × 12 cycles, begining at 4-6 weeks after chemoradiation
Camrelizumab
Camrelizumab is an antibody targeting PD-1 developed by Jiangsu Hengrui Medicine, China.
Best supportive care
Patients randomized to this arm will receive best supportive care after chemoradiation
No interventions assigned to this group
Interventions
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Camrelizumab
Camrelizumab is an antibody targeting PD-1 developed by Jiangsu Hengrui Medicine, China.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Tumor staged as III-IVA (AJCC 8th, except T3N0-1 or T4N0).
* Completed protocol-specified curative chemoradiotherapy, including gemcitabine and cisplatin induction chemotherapy, intensity-modulated radiotherapy, and concurrent cisplatin chemotherapy.
* Completion of the last radiation dose within 1 to 42 days before randomization
* Eastern Cooperative Oncology Group performance status ≤1.
* Adequate marrow function: neutrocyte count≥1.5×10e9/L, hemoglobin ≥90g/L and platelet count ≥100×10e9/L.
* Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) ≤2.5×upper limit of normal (ULN), and bilirubin ≤ 1.5×ULN.
* Adequate renal function: creatinine clearance rate ≥ 60 ml/min (Cockcroft-Gault formula).
* Patients must be informed of the investigational nature of this study and give written informed consent.
* Women of childbearing potential (WOCBP) who are sexually active must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of study drug. Men who are sexually active with WOCBP must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of the study drug.
Exclusion Criteria
* Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus DNA \>1×10e3 copies/ml or 200IU/ml
* Hepatitis C virus (HCV) antibody positive
* Has active autoimmune disease, except type I diabetes, hypothyroidism treated with replacement therapy, and skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia).
* Has any condition that required systemic corticosteroid (equivalent to prednisone \>10mg/d) or other immunosuppressive therapy within 28 days before informed consent. Patients received systemic corticosteroid equivalent to prednisone ≤10mg/d, inhale or topical corticosteroid will be allowed.
* Has a known history of active TB (bacillus tuberculosis) within 1 year; patients with adequately treated active TB over 1 year ago will be allowed.
* Has a known history of interstitial lung disease.
* Has received a live vaccine within 30 days before informed consent or will receive a live vaccine in the near future.
* Is pregnant or breastfeeding.
* Prior malignancy within 5 years, except in situ cancer, adequately treated non-melanoma skin cancer, and papillary thyroid carcinoma.
* Has known allergy to large molecule protein products or any compound of camrelizumab.
* Has a known history of human immunodeficiency virus (HIV) infection.
* Any other condition, including symptomatic heart failure, unstable angina, myocardial infarction, active infection requiring systemic therapy, mental illness or domestic/social factors, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results.
18 Years
65 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Jun Ma, MD
Professor
Principal Investigators
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Jun Ma, MD
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Locations
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First People's Hospital of Foshan
Foshan, Guangdong, China
Guangzhou Medical University Cancer Hospital
Guangzhou, Guangdong, China
Panyu central hospital
Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Cancer Hospital of Guangxi Medical University
Nanning, Guangxi, China
Cancer Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Tongji Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Xiangya Hospital Central South University
Changsha, Hunan, China
Xijing Hospital, Fourth Military Medical University
Xi’an, Shanxi, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Countries
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References
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Liang YL, Liu X, Shen LF, Hu GY, Zou GR, Zhang N, Chen CB, Chen XZ, Zhu XD, Yuan YW, Yang KY, Jin F, Hu WH, Xie FY, Huang Y, Han F, Tang LL, Mao YP, Lu LX, Sun R, He YX, Zhou YY, Long GX, Tang J, Chen LS, Zong JF, Jin T, Li L, Lin J, Huang J, Gong XY, Zhou GQ, Chen L, Li WF, Chen YP, Xu C, Lin L, Huang SH, Huang SW, Wang YQ, Huang CL, Feng HX, Hou M, Chen CH, Zheng SF, Li YQ, Hong SB, Jie YS, Li H, Yun JP, Zang SB, Liu SR, Lin QG, Li HJ, Tian L, Liu LZ, Zhao HY, Li JB, Lin AH, Liu N, Zhang Y, Guo R, Ma J, Sun Y. Adjuvant PD-1 Blockade With Camrelizumab for Nasopharyngeal Carcinoma: The DIPPER Randomized Clinical Trial. JAMA. 2025 May 13;333(18):1589-1598. doi: 10.1001/jama.2025.1132.
Huang SW, Jiang W, Xu S, Zhang Y, Du J, Wang YQ, Yang KY, Zhang N, Liu F, Zou GR, Jin F, Wu HJ, Zhou YY, Zhu XD, Chen NY, Xu C, Qiao H, Liu N, Sun Y, Ma J, Liang YL, Liu X. Systemic longitudinal immune profiling identifies proliferating Treg cells as predictors of immunotherapy benefit: biomarker analysis from the phase 3 CONTINUUM and DIPPER trials. Signal Transduct Target Ther. 2024 Oct 23;9(1):285. doi: 10.1038/s41392-024-01988-w.
Other Identifiers
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B2017-097-01
Identifier Type: -
Identifier Source: org_study_id
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