Clinical trial · Interventional
PD-1 Antibody Versus Best Supportive Care After Chemoradiation in Locoregionally Advanced Nasopharyngeal Carcinoma
Camrelizumab (PD-1 Antibody) Compared With Best Supportive Care After Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma: a Multi-center, Randomised Controlled, Phase 3 Trial (DIPPER)
NCT03427827CI-TRIAL-00075840DIPPERunknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This trial is aimed to investigate whether adjuvant PD-1 antibody treatment could improve survival in locoregionally advanced nasopharyngeal carcinoma compared to best supportive care.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nasopharyngeal Neoplasms | Nasopharyngeal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Camrelizumab | Drug | Camrelizumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Adjuvant PD-1 antibody arm
- description
- 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
- interventionNames
- Drug: Camrelizumab
- type
- NO_INTERVENTION
- label
- Best supportive care
- description
- Patients randomized to this arm will receive best supportive care after chemoradiation
Primary outcomes (1)
- measure
- failure-free survival
- timeFrame
- 3 years
- description
- calculated from the date of randomisation to the date of locoregional failure, distant failure, or death from any cause, whichever occurred first.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histologically confirmed nasopharyngeal carcinoma. * 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: * Age \> 65 or \< 18. * 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.
References
Publications (3)
- DERIVEDHuang SW, Liang YL, Tao YL, Li WF, Zhou GQ, Mao YP, Guo R, Chen L, Xu S, Liu X, Zhang N, Liu F, Shen LF, Zhou YY, Yuan YW, Zou GR, Jin F, Tang LL, Sun Y, Li YQ, Ma J, Liu N. Development of a Classifier for Metabolic Subtypes of Nasopharyngeal Carcinoma to Guide Personalized Immunotherapy Strategies: Biomarker Analysis of the Phase III CONTINUUM and DIPPER Trials. J Clin Oncol. 2026 Apr 10;44(11):1028-1039. doi: 10.1200/JCO-25-02111. Epub 2026 Mar 6. PMID 41791006
- DERIVEDLiang 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. PMID 40079940
- DERIVEDHuang 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. PMID 39438442