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

NCT07110558 | Not Yet Recruiting Phase 2

• 1 other identifier: 2025-FXY-068
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief 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 N1, where nodal involvement is strictly confined to the retropharyngeal lymph nodes.

Conditions

Nasopharyngeal Cancinoma (NPC)

Keywords

nasopharyngeal carcinoma; radiotherapy; immunotherapy

Outcome Measures

Primary Outcomes (1)

• Regional relapse-free survival (RRFS)

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

  2 years

Secondary Outcomes (7)

• Progress-free survival (PFS)

  2 years

• Overall Survival (OS)

  2 years

• Locoregional Relapse-Free Survival (LRRFS)

  2 years

• Distant Metastasis-Free Survival (DMFS)

  2 years

• Objective Response Rate （ORR）

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

Study Arms (1)

Toripalimab group

EXPERIMENTAL

NPC 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.

Radiation: Without prophylactic neck irradiation; Drug: PD-1 antibody (Toripalimab); Drug: Cisplatin

Interventions

Without prophylactic neck irradiation RADIATION

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

Toripalimab group

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

Toripalimab group

Cisplatin DRUG

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

Toripalimab group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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;

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen Universitty Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Related Publications (5)

• 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.

  PMID: 29658848 BACKGROUND

• 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.

  PMID: 36856617 BACKGROUND

• 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.

  PMID: 35240053 BACKGROUND

• 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.

  PMID: 38015220 BACKGROUND

• 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.

  PMID: 39522541 BACKGROUND

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

toripalimab; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Haiqiang Mai, MD,PhD

  Sun Yat-sen Universitty Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiuyan Chen, MD,PhD

CONTACT

86-20-87343380; chenqy@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 7, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): August 14, 2029
• Study Completion (Estimated): August 14, 2032
• Last Updated: August 7, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)