Immunotherapy versus capecitabine maintenance after chemo‑chemoradiotherapy for high‑risk nasopharyngeal cancer

A Randomized, Open-Label, Phase II Clinical Study Comparing Immunotherapy Combined With Induction Chemotherapy Followed by Concurrent Chemoradiotherapy and Immunotherapy Maintenance Versus Capecitabine Maintenance in Locally Advanced High-Risk Nasopharyngeal Carcinoma

This test compares PD‑1 immunotherapy maintenance to capecitabine maintenance after chemo‑chemoradiotherapy for people with high‑risk locally advanced nasopharyngeal cancer who responded to initial chemo‑immunotherapy.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 142 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Sun Yat-sen University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07392320 on ClinicalTrials.gov

What this trial studies

This is a randomized, open‑label phase II trial for patients with high‑risk locally advanced nasopharyngeal carcinoma (T4 or N3 or EBV DNA ≥1500 copies/ml) who have shown a complete or partial response after three cycles of induction chemo‑immunotherapy. Participants are randomized to receive sequential TP (taxane+platinum) combined with a PD‑1 antibody followed by concurrent chemoradiotherapy and PD‑1 maintenance, or to receive capecitabine maintenance. The study will monitor treatment tolerability, recurrence, and survival outcomes to determine whether the immunotherapy maintenance strategy offers advantages over capecitabine. All treatment and follow‑up are conducted at Sun Yat‑sen University Cancer Center in Guangzhou.

Who should consider this trial

Good fit: Ideal candidates are adults 18–70 with pathologically confirmed non‑keratinizing nasopharyngeal carcinoma who meet the high‑risk criteria (T4 or N3 or EBV DNA ≥1500 copies/ml), have ECOG 0–1, adequate organ function, and achieved a complete or partial response after three cycles of induction immunochemotherapy.

Not a fit: Patients who do not respond to induction chemo‑immunotherapy, have poor performance status, inadequate organ function, or non‑eligible tumor histology are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the immunotherapy maintenance approach could prolong recurrence‑free and overall survival for patients with high‑risk locally advanced nasopharyngeal cancer.

How similar studies have performed: Other trials have shown that PD‑1 antibodies can improve outcomes in locally advanced nasopharyngeal carcinoma, but the exact sequence tested here versus capecitabine maintenance is relatively novel and needs confirmation.

Eligibility criteria

Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.
* Patients with personality or psychiatric disorders, or those lacking or with limited legal capacity.
* Patients who are hepatitis B surface antigen (HBsAg) positive with peripheral blood hepatitis B virus DNA (HBV DNA) ≥ 1000 copies/ml. Patients who are HBsAg positive but have HBV DNA \< 1000 copies/ml are eligible if the investigator determines that their chronic hepatitis B is stable and does not pose an increased risk.
* Patients with a positive HCV antibody test result, unless the polymerase chain reaction (PCR) test for HCV RNA is negative.

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Pei-Yu Huang

Conditions Nasopharangeal Cancer; high-risk locally advanced nasopharyngeal carcinoma