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Nasopharyngeal NeoplasmsPhase 3DIPPERNCT03427827

PD-1 Antibody Versus Best Supportive Care After Chemoradiation in Locoregionally Advanced Nasopharyngeal Carcinoma

A Phase 3 study testing Camrelizumab in people with Nasopharyngeal Neoplasms, run by Sun Yat-sen University at 11 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Nasopharyngeal Neoplasms
What is being tested?
Camrelizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
11 sitesChina
Study dates
2 Jul 2018to Feb 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

China11 sites

  • Xiangya Hospital Central South University

    Changsha, Hunan

  • West China Hospital, Sichuan University

    Chengdu, Sichuan

  • First People's Hospital of Foshan

    Foshan, Guangdong

  • Guangzhou Medical University Cancer Hospital

    Guangzhou, Guangdong, 510060

  • Panyu central hospital

    Guangzhou, Guangdong, 510060

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

  • Cancer Hospital of Guizhou Medical University

    Guiyang, Guizhou

  • Cancer Hospital of Guangxi Medical University

    Nanning, Guangxi

  • Tongji Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei

  • Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei

  • Xijing Hospital, Fourth Military Medical University

    Xi’an, Shanxi

Other trials in China

About this study

Official title: 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)

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.

Read the detailed description

In this multicenter, randomised controlled, phase 3 trial, patients with stage III-IVA (AJCC/UICC 8th system, except T3-4N0 and T3N1) non-metastatic nasopharyngeal carcinoma will be randomized in a 1:1 ratio to recieve PD-1 antibody for 12 doses every 3 weeks or best supportive care after curative chemoradiation.

Being tested
Camrelizumab
Keywords
PD-1 antibody, Adjuvant treatment, Immune checkpoint inhibitors
Medical subject headings
Nasopharyngeal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CamrelizumabDrug

    Also called SHR-1210

    Camrelizumab is an antibody targeting PD-1 developed by Jiangsu Hengrui Medicine, China.

Study groups in NCT03427827
Study groupRoleWhat they receive
Adjuvant PD-1 antibody armExperimentalPatients 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
Receives: Drug: Camrelizumab
Best supportive careNo interventionPatients randomized to this arm will receive best supportive care after chemoradiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. failure-free survival

    calculated from the date of randomisation to the date of locoregional failure, distant failure, or death from any cause, whichever occurred first.

    Measured: 3 years

Secondary outcomes (5)

  1. overall survival

    calculated from date of randomisation to death

    Measured: 5 years

  2. distant metastasis-free survival

    calculated from date of randomisation to the first distant failure

    Measured: 3 years

  3. locoregional recurrence-free survival

    calculated from date of randomisation to the first locoregional failure

    Measured: 3 years

  4. adverse events (AEs) and severe adverse events (SAE)

    graded according to NCI CTCAE v5.0

    Measured: 3 years

  5. quality of life (QoL)

    the change of QoL from randomization to 36 months after chemoradiation, graded according to EORTC QLQ-C30 V3.0

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2018
  2. Study start2 Jul 2018
  3. Primary completion6 Feb 2024
  4. Study completionFeb 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
450 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03427827
Sponsor's protocol ID
B2017-097-01
Acronym
DIPPER
Status last verified
Apr 2024
First submitted
3 Feb 2018
Last updated
9 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Complete de-identified patient data set

Publications

  • Huang 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.

    PubMed 41791006

  • 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.

    PubMed 40079940

  • 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.

    PubMed 39438442

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Camrelizumab in people with Nasopharyngeal Neoplasms, run by Sun Yat-sen University at 11 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

failure-free survival (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03427827, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.

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