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Nasopharyngeal Cancinoma (NPC)Phase 2PUPANCT07110558

Radiotherapy Omitting Prophylactic Neck Irradiation With Neoadjuvant and Adjuvant Toripalimab in Nasopharyngeal Carcinoma

A Phase 2 study testing Without prophylactic neck irradiation, PD-1 antibody (Toripalimab) and Cisplatin in people with Nasopharyngeal Cancinoma (NPC), run by Sun Yat-sen University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This single-arm, phase 2 trial evaluates the efficacy and safety of de-escalated radiotherapy (restricted to the primary tumor, omitting prophylactic neck irradiation) combined with neoadjuvant and adjuvant toripalimab immunotherapy, and concurrent chemotherapy in patients with nasopharyngeal carcinoma staged N0 or… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Nasopharyngeal Cancinoma (NPC)
What is being tested?
Without prophylactic neck irradiation, PD-1 antibody (Toripalimab) and Cisplatin
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
1 siteChina
Study dates
15 Aug 2025to 14 Aug 2032
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: 18 Years to 70 Years;
  • Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III
  • Satisfactory performance status: ECOG (Eastern Cooperative OncologyGroup) scale 0-1
  • TNM stage based on AJCC 9th edition with N0-1 (retroperitoneal lymph nodes only), and either one following criteria:
  • T2 and primary gross tumor volume (GTV) greater than 30.0 cm3;
  • T3-4;
Show all 12Show fewer
  • Patients' lymph node without adverse features (no central necrosis, no muscle/skin invasion, no lymph node fusion).
  • Male and no pregnant female
  • Normal bone marrow function: white blood cell count > 4×10^9/L, hemoglobin > 90g/L, platelet count > 100×10^9/L;
  • Normal liver function: total bilirubin (TBIL) < upper limit of normal (ULN), alanine transaminase (ALT) and aspartate transaminase (AST) < 1.5 × ULN;
  • Normal kidney function: creatinine clearance rate ≥ 60 ml/min;
  • Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedule;

Who cannot join

  • Patients have evidence of relapse or distant metastasis
  • Histologically confirmed keratinizing squamous cell carcinoma (WHO I)
  • Patients with positive cervical lymph nodes
  • Patients who have been treated with inhibitors of immune regulation (CTLA-4, PD-1, PD-L1, etc.).
  • Receiving radiotherapy or chemotherapy previously
  • Patients with active immunodeficiency disease and history of immunodeficiency disease
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  • Anti-human immunodeficiency virus (HIV) positive or diagnosed with acquired immune deficiency syndrome (AIDS)
  • Chronic treatment with systemic glucocorticoid (dose equivalent to or over 10 mg prednisone per day) or any other form of immunosuppressive therapy. Subjects who used inhaled or topical corticosteroids were eligible.
  • Active tuberculosis: active tuberculosis in the past 1 year should be excluded regardless with treatment, history of active tuberculosis over 1 year should be excluded except that previous regulatory anti-tuberculosis treatment is proved.
  • HBV DNA >2000 cps/ml (or HBV DNA > 2000 IU/ml); or HCV RNA >1000 cps/ml; Hepatitis B surface antigen (HBsAg) positive and HCV antibody positive.
  • Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
  • Suffered from other malignant tumors (except the cure of basal cell carcinoma or uterine cervical carcinoma in situ) previously.
  • Uncontrolled heart disease, for example: 1) heart failure (NYHA level ≥ 2), 2) unstable angina, 3) myocardial infarction in past 1 year, 4) supraventricular or ventricular arrhythmia requiring treatment or intervention.
  • Patients with significantly lower heart, liver, lung, kidney and bone marrow function.
  • Severe, uncontrolled medical conditions and infections.
  • At the same time using other test drugs or in other clinical trials.
  • Refusal or inability to sign informed consent to participate in the trial.
  • Other treatment contraindications.
  • Emotional disturbance or mental illness, no civil capacity or limited capacity for civil conduct.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Qiuyan Chen, MD,PhD contact

86-20-87343380

chenqy@sysucc.org.cn

China1 site

  • Sun Yat-sen Universitty Cancer Center

    Guangzhou, Guangdong, 510060

    Hai-Qiang Mai, MD,PhD, +862087343643, maihq@sysucc.org.cn

Other trials in China

About this study

Official title: A Single-arm, Phase II Trial of Radiotherapy Without Prophylactic Neck Irradiation in Combination With Neoadjuvant and Adjuvant Anti-PD-1 Antibody Toripalimab for Nasopharyngeal Carcinoma

This single-arm, phase 2 trial evaluates the efficacy and safety of de-escalated radiotherapy (restricted to the primary tumor, omitting prophylactic neck irradiation) combined with neoadjuvant and adjuvant toripalimab immunotherapy, and concurrent chemotherapy in patients with nasopharyngeal carcinoma staged N0 or N1, where nodal involvement is strictly confined to the retropharyngeal lymph nodes.

Read the detailed description

The goals of this clinical trial includes: ① To assess the regional relapse-free survival (RRFS) and safety after radiotherapy without prophylactic neck irradiation in combination with neoadjuvant and adjuvant PD-1 antibody toripalimab and cisplatin concurrent chemotherapy for N0-1 (restricted to retropharyngeal lymph nodes) patients with nasopharyngeal carcinoma; ② To evaluate the impact of radiotherapy without prophylactic neck irradiation on 2-year overall survival (OS), 2-year progress-free survival (PFS), 2-year distant metastasis-free survival (DMFS), and 2-year locoregional relapse-free survival (LRRFS) for N0-1 ( limited to retropharyngeal lymph nodes) patients with nasopharyngeal carcinoma; ③ To explore the impact of radiotherapy without prophylactic neck irradiation on toxicities and quality of life; ④ To explore the relationship between clinical factors and the impact of neoadjuvant and adjuvant PD-1 antibody, radiotherapy without prophylactic neck irradiation on the survival of patients; ⑤ To explore the biomarkers of sensitivity to immunotherapy, chemotherapy and radiotherapy for patients with nasopharyngeal carcinoma and the underlying mechanism.

For these purposes, we plan to prospectively enroll T2N0-1 and primary gross tumor volume (GTV) greater than 30.0 cm3 or T3-4N0-1 stage NPC patients, whose N1 restricted to retropharyngeal lymph nodes from one center in China. The patients will receive 2 cycles of neoadjuvant PD-1 antibody (toripalimab monotherapy, 240 mg, every two weeks, intravenous infusion) followed by concurrent cisplatin (100 mg/m2 intravenously) on days 1, 22, and 43 during intensity-modulated radiotherapy (IMRT), and adjuvant toripalimab (240 mg intravenously) once every 3 weeks for up to eight cycles. All participants will be treated with IMRT restricted to primary tumor without prophylactic neck irradiation. The clinical outcomes, safety, complications, and quality of life will be explored in the RT without prophylactic neck irradiation.

Being tested
Without prophylactic neck irradiation, PD-1 antibody (Toripalimab), Cisplatin
Keywords
nasopharyngeal carcinoma, radiotherapy, immunotherapy
Medical subject headings
Nasopharyngeal Carcinoma

What participants receive

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

  • Without prophylactic neck irradiationRadiation

    Intensity-modulated radiotherapy restricted to the primary tumor, omitting prophylactic neck irradiation.

  • PD-1 antibody (Toripalimab)Drug

    Toripalimab 240mg every 2 weeks with a total of 2 cycles as neoadjuvant anti-PD-1 immunotherapy; Toripalimab 240mg every 3 weeks with a total of 8 cycles as adjuvant anti-PD-1 immunotherapy after CCRT

  • CisplatinDrug

    Cisplatin 100mg/m2(every three weeks), Day 1, Day 22, Day 43 of intensity modulated radiotherapy

Study groups in NCT07110558
Study groupRoleWhat they receive
Toripalimab groupExperimentalNPC Patients without cervical lymph node metastasis (N0 or N1 restricted to retropharyngeal lymph nodes) received two cycles of toripalimab, followed by cisplatin concurrent chemoradiotherapy without prophylactic neck irradiation, and adjuvant toripalimab up to 8 cycles.
Receives: Radiation: Without prophylactic neck irradiation; Drug: PD-1 antibody (Toripalimab); Drug: Cisplatin

What is being measured

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

  1. Regional relapse-free survival (RRFS)

    Defined as the time from registration to documented nodal relapse or non-cancer-specific death.

    Measured: 2 years

Secondary outcomes (7)

  1. Progress-free survival (PFS)

    Defined as the time from registration to documented disease progression or non-cancer-specific death.

    Measured: 2 years

  2. Overall Survival (OS)

    Defined as the time from registration to death from any cause.

    Measured: 2 years

  3. Locoregional Relapse-Free Survival (LRRFS)

    Defined as the time from registration to documented locoregional recurrence or non-cancer-specific death.

    Measured: 2 years

  4. Distant Metastasis-Free Survival (DMFS)

    Defined from registration to documented distant metastasis or noncancer-specific death.

    Measured: 2 years

  5. Objective Response Rate （ORR）

    An objective response is defined as either a confirmed CR or a PR, as determined by the investigator using RECIST v1.1Response Evaluation Criteria in Solid Tumors (RECIST) from the National Cancer Institute (NCI).

    Measured: After the completion of the neoadjuvant PD-1 antibody and chemoradiotherapy treatment

  6. Incidence rate of acute and late adverse events (AEs)

    Analysis of adverse events (AEs) are based on treatment-related AEs (trAEs) and immune-related AEs (irAEs), and all-grade AEs and grade 3-4 AEs. Acute AEs are evaluated by investigators according to the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE 5.0). Late radiation toxicities were assessed using the Radiation Therapy Oncology Group (RTOG) and European Organisation for Research and Treatment of Cancer (EORTC).

    Measured: 2 years

  7. Change of QoL (quality of life)

    QoL scores were assessed by using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTCQLQ-C30) and Quality-of-Life Head and Neck 35 items (QLQ-H\&N35) before neoadjuvant PD-1 antibody, before radiotherapy, at the end of radiotherapy, at 6 months after radiotherapy and 12 months after radiotherapy.

    Measured: 1 year

Timeline

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

  1. First posted7 Aug 2025
  2. Study start15 Aug 2025 (estimated)
  3. Primary completion14 Aug 2029 (estimated)
  4. Study completion14 Aug 2032 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
59 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07110558
Sponsor's protocol ID
2025-FXY-068
Acronym
PUPA
Status last verified
Jul 2025
First submitted
31 Jul 2025
Last updated
7 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Complete de-identified patient data set will be submitted to the Research Data Deposit (RDD) public platform (http://www.researchdata.org.cn) and available from the principal investigators upon reasonable request.

Publications

  • Forde PM, Chaft JE, Smith KN, Anagnostou V, Cottrell TR, Hellmann MD, Zahurak M, Yang SC, Jones DR, Broderick S, Battafarano RJ, Velez MJ, Rekhtman N, Olah Z, Naidoo J, Marrone KA, Verde F, Guo H, Zhang J, Caushi JX, Chan HY, Sidhom JW, Scharpf RB, White J, Gabrielson E, Wang H, Rosner GL, Rusch V, Wolchok JD, Merghoub T, Taube JM, Velculescu VE, Topalian SL, Brahmer JR, Pardoll DM. Neoadjuvant PD-1 Blockade in Resectable Lung Cancer. N Engl J Med. 2018 May 24;378(21):1976-1986. doi: 10.1056/NEJMoa1716078. Epub 2018 Apr 16.

    PubMed 29658848

  • Patel SP, Othus M, Chen Y, Wright GP Jr, Yost KJ, Hyngstrom JR, Hu-Lieskovan S, Lao CD, Fecher LA, Truong TG, Eisenstein JL, Chandra S, Sosman JA, Kendra KL, Wu RC, Devoe CE, Deutsch GB, Hegde A, Khalil M, Mangla A, Reese AM, Ross MI, Poklepovic AS, Phan GQ, Onitilo AA, Yasar DG, Powers BC, Doolittle GC, In GK, Kokot N, Gibney GT, Atkins MB, Shaheen M, Warneke JA, Ikeguchi A, Najera JE, Chmielowski B, Crompton JG, Floyd JD, Hsueh E, Margolin KA, Chow WA, Grossmann KF, Dietrich E, Prieto VG, Lowe MC, Buchbinder EI, Kirkwood JM, Korde L, Moon J, Sharon E, Sondak VK, Ribas A. Neoadjuvant-Adjuvant or Adjuvant-Only Pembrolizumab in Advanced Melanoma. N Engl J Med. 2023 Mar 2;388(9):813-823. doi: 10.1056/NEJMoa2211437.

    PubMed 36856617

  • Tang LL, Huang CL, Zhang N, Jiang W, Wu YS, Huang SH, Mao YP, Liu Q, Li JB, Liang SQ, Qin GJ, Hu WH, Sun Y, Xie FY, Chen L, Zhou GQ, Ma J. Elective upper-neck versus whole-neck irradiation of the uninvolved neck in patients with nasopharyngeal carcinoma: an open-label, non-inferiority, multicentre, randomised phase 3 trial. Lancet Oncol. 2022 Apr;23(4):479-490. doi: 10.1016/S1470-2045(22)00058-4. Epub 2022 Feb 28.

    PubMed 35240053

  • Mai HQ, Chen QY, Chen D, Hu C, Yang K, Wen J, Li J, Shi Y, Jin F, Xu R, Pan J, Qu S, Li P, Hu C, Liu YC, Jiang Y, He X, Wang HM, Lim WT, Liao W, He X, Chen X, Wang S, Yuan X, Li Q, Lin X, Jing S, Chen Y, Lu Y, Hsieh CY, Yang MH, Yen CJ, Samol J, Luo X, Wang X, Tang X, Feng H, Yao S, Keegan P, Xu RH. Toripalimab Plus Chemotherapy for Recurrent or Metastatic Nasopharyngeal Carcinoma: The JUPITER-02 Randomized Clinical Trial. JAMA. 2023 Nov 28;330(20):1961-1970. doi: 10.1001/jama.2023.20181.

    PubMed 38015220

  • Liu SL, Li XY, Yang JH, Wen DX, Guo SS, Liu LT, Li YF, Luo MJ, Xie SY, Liang YJ, Sun XS, Yang ZC, Lv XF, Luo DH, Li JB, Liu Q, Wang P, Guo L, Mo HY, Sun R, Yang Q, Lan KQ, Jia GD, Li R, Zhao C, Xu RH, Chen QY, Tang LQ, Mai HQ. Neoadjuvant and adjuvant toripalimab for locoregionally advanced nasopharyngeal carcinoma: a randomised, single-centre, double-blind, placebo-controlled, phase 2 trial. Lancet Oncol. 2024 Dec;25(12):1563-1575. doi: 10.1016/S1470-2045(24)00504-7. Epub 2024 Nov 7.

    PubMed 39522541

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Without prophylactic neck irradiation, PD-1 antibody (Toripalimab) and Cisplatin in people with Nasopharyngeal Cancinoma (NPC), run by Sun Yat-sen University at 1 site 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 12 inclusion and 19 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: opening soon, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Qiuyan Chen, MD,PhD (86-20-87343380, chenqy@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Regional relapse-free survival (RRFS) (time frame: 2 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 NCT07110558, which also lists 5 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 7 Aug 2025.

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