A Phase II Trial Comparing Immunotherapy Versus Capecitabine Maintenance After Chemo-chemoradiotherapy for High-risk Nasopharyngeal Carcinoma

NCT07392320 | Recruiting Phase 2

• 1 other identifier: 2025-FXY-476
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the investigators designed a randomized, open-label, phase II clinical trial for high-risk locally advanced nasopharyngeal carcinoma (T4 or N3 or EBV DNA ≥1500 copies/ml, AJCC 9th edition) that is sensitive to chemotherapy and PD-1 monoclonal antibody therapy. The trial compares sequential treatment with the TP regimen combined with PD-1 monoclonal antibody followed by concurrent chemoradiotherapy and PD-1 maintenance therapy versus capecitabine maintenance therapy. The aim is to provide high-quality clinical evidence for optimizing the treatment strategy for high-risk locally advanced nasopharyngeal carcinoma.

Conditions

Nasopharangeal Cancer

Keywords

high-risk locally advanced nasopharyngeal carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  Progression-free survival is calculated from the date of randomization to the date of documented local or regional relapse, distant metastasis, or death from any cause, whichever occurred first.

  3 years

Secondary Outcomes (5)

• Overall survival

  3 years

• Locoregional recurrence-free survival

  3 years

• Distant metastasis-free survival

  3 years

• Incidence of acute toxicity as assessed by CTCAE v5.0

  3 years

• Incidence of late toxicity as assessed by the Late Radiation Morbidity Scoring Scheme of the Radiation Therapy Oncology Group

  3 years

Study Arms (2)

Adjuvant immunotherapy arm

EXPERIMENTAL

Adjuvant PD-1 monoclonal antibody maintenance

Drug: TP+PD1+CCRT; Drug: PD-1 Monoclonal Antibody

Adjuvant chemotherapy arm

EXPERIMENTAL

Adjuvant capecitabine maintenance

Drug: TP+PD1+CCRT; Drug: Capecitabine

Interventions

TP+PD1+CCRT DRUG

Induction Chemoimmunotherapy (3 cycles, Q3W): Induction chemotherapy consisted of three cycles of docetaxel (75 mg/m², day 1), cisplatin (75 mg/m², day 1), and penpulimab (200 mg, day 1), administered every 3 weeks. Concurrent Chemotherapy (3 weeks post-induction, 2 cycles, Q3W): concurrent cisplatin 100mg/m2 every 21days for two cycles during Intensity modulated-radiotherapy (IMRT)

Adjuvant chemotherapy arm; Adjuvant immunotherapy arm

PD-1 Monoclonal Antibody DRUG

Penpulimab 200 mg every 3 weeks for 8 cycles

Adjuvant immunotherapy arm

Capecitabine DRUG

Capecitabine 1000 mg/m² BID, days 1-14, for 8 cycles.

Adjuvant chemotherapy arm

Eligibility Criteria

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

You may qualify if:

• Voluntary participation and written informed consent must be signed.
• Age between 18 and 70 years, male or non-pregnant female.
• Pathologically confirmed nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated type, i.e., WHO type II or type III).
• Stage III disease (AJCC 9th edition staging) or pre-treatment plasma Epstein-Barr virus DNA (EBV DNA) ≥ 1500 copies/ml.
• Efficacy after 3 cycles of induction immunochemotherapy assessed as complete response (CR) or partial response (PR) by nasopharyngoscopy and contrast-enhanced MRI of the nasopharynx and neck.
• ECOG performance status score of 0 or 1.
• Adequate hematological function: Hemoglobin (HGB)≥90g/L, White Blood Cell (WBC) ≥ 4.010\^9/L, and Platele (PLT) ≥10010\^9/L.
• Adequate hepatic function: ALT and AST≤2.5Upper Limit of Normal (ULN), total bilirubin ≤2.0ULN, and serum albumin≥30g/L.
• Adequate renal function: Serum creatinine ≤ 1.5\*ULN or calculated creatinine clearance (CrCl) ≥ 60 mL/min (using the Cockcroft-Gault formula).
• International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 \*ULN (unless the subject is receiving anticoagulant therapy and the coagulation parameters (PT/INR and APTT) are within the expected therapeutic range for the anticoagulant at the time of screening).

You may not qualify if:

• Patients with recurrent or distant metastatic nasopharyngeal carcinoma.
• Pathological diagnosis of keratinizing squamous cell carcinoma (WHO Type I).
• Patients who have previously received radiotherapy or systemic chemotherapy.
• Women who are pregnant or breastfeeding, or individuals of childbearing potential who are not using effective contraception.
• HIV positive.
• History of other malignancies (except for cured basal cell carcinoma or cervical carcinoma in situ).
• Patients who have previously received immune checkpoint inhibitors (e.g., CTLA-4, PD-1, PD-L1 inhibitors).
• Patients with immunodeficiency diseases or a history of organ transplantation.
• History of autoimmune diseases, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.
• Patients who have received high-dose glucocorticoids, anticancer monoclonal antibodies, or other immunosuppressive therapy within 4 weeks.
• Patients with significantly impaired cardiac, hepatic, pulmonary, renal, or bone marrow function.
• Patients with severe, uncontrolled medical conditions or infections.
• Concurrent use of other investigational drugs or participation in another clinical trial.
• Refusal or inability to sign the informed consent form for trial participation.
• Patients with other contraindications to the treatment.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Interventions

spartalizumab; Capecitabine

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Pei-Yu Huang

CONTACT

+86-20-87343379; huangpy@sysucc.org.cn

Qi Yang

CONTACT

yangqi@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 6, 2026
• Study Start: February 10, 2026
• Primary Completion (Estimated): February 10, 2031
• Study Completion (Estimated): February 10, 2033
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

CN (1)