Adaptive Immunotherapy for Nasopharyngeal Carcinoma

NCT07154069 | Recruiting Phase 3 DMC

• 1 other identifier: B2025-489-01
• Study Type: interventional
• Target: 802
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To assess whether radiotherapy alone is non-inferior to concurrent chemoradiotherapy with respect to event-free survival and superior in reducing treatment-related nausea in low-risk locoregionally advanced nasopharyngeal carcinoma patients who achieve complete or partial response and undetectable serum EBV-DNA following induction chemoimmunotherapy.
2. 2.To evaluate whether adjuvant capecitabine and immunotherapy after concurrent chemoradiotherapy improves event-free survival compared to adjuvant immunotherapy in high-risk locoregionally advanced nasopharyngeal carcinoma patients with stable disease or detectable serum EBV-DNA after induction chemoimmunotherapy.

Conditions

Nasopharyngeal Cancinoma (NPC)

Outcome Measures

Primary Outcomes (2)

• Event-free survival

  The primary endpoint was event-free survival from randomisation to disease recurrence (locoregional or distant) or death from any cause in the intention-to-treat population.

  3 year

• Incidence rates of vomiting as assessed by CTCAE v5.0

  In the low-risk arm, the primary outcome included the incidence rates of vomiting (evaluated according to the Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0).

  3 year

Secondary Outcomes (8)

• Overall survival

  3 year

• Locoregional relapse-free survival

  3 year

• Distant metastasis-free survival

  3 year

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  3 year

• Number of participants with treatment-related adverse events as assessed by RTOG/EORTC System

  3 year

Study Arms (4)

Low risk arm 1

EXPERIMENTAL

Radiotherapy alone

Radiation: Radical radiotherapy of nasopharynx and neck; Drug: Toripalimab

Low risk arm 2

ACTIVE COMPARATOR

Concurrent chemoradiotherapy

Radiation: Radical radiotherapy of nasopharynx and neck; Drug: Concurrent chemoradiotherapy (cCRT); Drug: Toripalimab

High risk arm 1

EXPERIMENTAL

Adjuvant capecitabine and immunotherapy after concurrent chemoradiotherapy

Radiation: Radical radiotherapy of nasopharynx and neck; Drug: Capecitabine; Drug: Concurrent chemoradiotherapy (cCRT); Drug: Toripalimab

High risk arm 2

ACTIVE COMPARATOR

Adjuvant immunotherapy after concurrent chemoradiotherapy

Radiation: Radical radiotherapy of nasopharynx and neck; Drug: Concurrent chemoradiotherapy (cCRT); Drug: Toripalimab

Interventions

Radical radiotherapy of nasopharynx and neck RADIATION

Radical radiotherapy of nasopharynx and neck

High risk arm 1; High risk arm 2; Low risk arm 1; Low risk arm 2

Capecitabine DRUG

Adjuvant metronomic capecitabine (650 mg/m² twice daily) for one year

High risk arm 1

Concurrent chemoradiotherapy (cCRT) DRUG

Concurrent chemoradiotherapy

High risk arm 1; High risk arm 2; Low risk arm 2

Toripalimab DRUG

Adjuvant Toripalimab (240mg day1, Q3W )

High risk arm 1; High risk arm 2; Low risk arm 1; Low risk arm 2

Eligibility Criteria

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

You may qualify if:

• years;
• Newly diagnosed, pathologically confirmed non-keratinizing carcinoma (according to WHO criteria);
• Locoregionally advanced nasopharyngeal carcinoma (Stage II-III) as defined by the 9th edition of the American Joint Committee on Cancer (AJCC) staging system;
• ECOG performance status: 0-1;
• Adequate bone marrow function: white blood cell count \> 4 × 10⁹/L, hemoglobin \> 90 g/L, platelet count \> 100 × 10⁹/L;
• Normal renal and hepatic function: total bilirubin ≤ 1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤ 2.5 × ULN; alkaline phosphatase ≤ 2.5 × ULN; creatinine clearance ≥ 60 mL/min;
• Normal thyroid function, amylase, lipase, pituitary function;
• Completion of 3 cycles of GP regimen induction chemotherapy combined with PD-1 inhibitor immunotherapy;
• Patients must provide signed informed consent and be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures;
• Female participants of childbearing potential must agree to use reliable contraceptive methods (e.g., condoms, regular use of oral contraceptives as prescribed) from screening until one year after treatment.

You may not qualify if:

• T3N0-1, according to the American Joint Committee on Cancer (AJCC) Staging System, 9th Edition;
• Disease progression after induction therapy;
• Hepatitis B surface antigen (HBsAg) positive with HBV DNA \>1×10³ copies/mL, or anti-hepatitis C virus (HCV) antibody positive;
• Anti-HIV antibody positive or diagnosed with acquired immunodeficiency syndrome (AIDS);
• Active tuberculosis;
• Active, known, or suspected autoimmune disease. Exceptions include type 1 diabetes, hypothyroidism requiring hormone replacement therapy, and skin disorders not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia);
• History of interstitial lung disease or pneumonia requiring oral or intravenous steroid treatment within the past year;
• Chronic systemic glucocorticoid therapy or any other form of immunosuppressive therapy. Subjects using inhaled or topical corticosteroids are eligible;
• Uncontrolled cardiac disease;
• Pregnant or lactating women;
• History or current diagnosis of another malignancy, except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, or papillary thyroid carcinoma;
• Known allergy to macromolecular protein preparations or any component of toripalimab;
• Active infection requiring systemic treatment within one week prior to enrollment;
• Administration of a live vaccine within 30 days before the first dose of toripalimab;
• History of organ transplantation;

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Interventions

Capecitabine; Chemoradiotherapy; toripalimab

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Central Study Contacts

Ling-Long Tang

CONTACT

02087343840; tangll@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 4, 2025
• Study Start: November 13, 2025
• Primary Completion (Estimated): September 1, 2031
• Study Completion (Estimated): September 1, 2033
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)