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Clinical Trials in China / NCT07392320
Recruiting Phase 2

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

NCT07392320 · tracked via the Priya Life Science China tracker
Sponsor
Sun Yat-sen University
Phase
Phase 2
Started
2026-02-10
Last updated
2026-04-24

Condition(s) studied

Nasopharangeal Cancer

Investigational drug(s) / intervention(s)

TP+PD1+CCRTPD-1 Monoclonal AntibodyCapecitabine

TP+PD1+CCRT: 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)

PD-1 Monoclonal Antibody: Penpulimab 200 mg every 3 weeks for 8 cycles

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Sun Yat-sen University Cancer Center Guangzhou Guangdong Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07392320 on ClinicalTrials.gov ↗ ← All trials in China