NCT06349889 Adebrelimab and Chemoradiotherapy in High-risk LANPC
| NCT ID | NCT06349889 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Sun Yat-sen University |
| Condition | Nasopharyngeal Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-07-23 |
| Primary Completion | 2028-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2024-07-23 with a primary completion date of 2028-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This trial aims to study the role of Adebrelimab combined with induction chemotherapy plus concurrent chemoradiotherapy (IC+CCRT) for high-risk locoregionally advanced nasopharyngeal carcinoma(LANPC).
Eligibility Criteria
Inclusion Criteria: 1. Patients with histologically confirmed nasopharyngeal carcinoma. 2. Tumor staged as IVA+T3N2M0 (AJCC 8th). 3. Eastern Cooperative Oncology Group performance status ≤1. 4. Adequate marrow function: neutrocyte count≥1.5×10e9/L, hemoglobin ≥90g/L and platelet count ≥100×10e9/L. 5. Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) ≤2.5×upper limit of normal (ULN), and bilirubin ≤ 1.5×ULN. 6. Adequate renal function: creatinine clearance rate ≥ 60 ml/min (Cockcroft-Gault formula). 7. Patients must be informed of the investigational nature of this study and give written informed consent. 8. Women of childbearing potential (WOCBP) who are sexually active must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of study drug. Men who are sexually active with WOCBP must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of the study drug Exclusion Criteria: 1. Age \> 65 or \< 18. 2. Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus DNA \>1×10e3 copies/ml or 200IU/ml 3. Hepatitis C virus (HCV) antibody positive 4. Has active autoimmune disease, except type I diabetes, hypothyroidism treated with replacement therapy, and skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia). 5. Has any condition that required systemic corticosteroid (equivalent to prednisone \>10mg/d) or other immunosuppressive therapy within 28 days before informed consent. Patients received systemic corticosteroid equivalent to prednisone ≤10mg/d, inhale or topical corticosteroid will be allowed. 6. Has a known history of active TB (bacillus tuberculosis) within 1 year; patients with adequately treated active TB over 1 year ago will be allowed. 7. Has a known history of interstitial lung disease. 8. Has received a live vaccine within 30 days before informed consent or will receive a live vaccine in the near future. 9. Is pregnant or breastfeeding. 10. Prior malignancy within 5 years, except in situ cancer, adequately treated non-melanoma skin cancer, and papillary thyroid carcinoma. 11. Has known allergy to large molecule protein products or any compound of Adebrelimab. 12. Has a known history of human immunodeficiency virus (HIV) infection. 13. Any other condition, including symptomatic heart failure, unstable angina, myocardial infarction, active infection requiring systemic therapy, mental illness or domestic/social factors, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results.
Contact & Investigator
Jun Ma, M.D.
PRINCIPAL INVESTIGATOR
Sun Yat-Sen University Cancer Center
Frequently Asked Questions
Who can join the NCT06349889 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Nasopharyngeal Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06349889 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06349889 currently recruiting?
Yes, NCT06349889 is actively recruiting participants. Contact the research team at majun2@mail.sysu.edu.cn for enrollment information.
Where is the NCT06349889 trial being conducted?
This trial is being conducted at Xiamen, China, Guangzhou, China, Guangzhou, China, Chengdu, China.
Who is sponsoring the NCT06349889 clinical trial?
NCT06349889 is sponsored by Sun Yat-sen University. The principal investigator is Jun Ma, M.D. at Sun Yat-Sen University Cancer Center. The trial plans to enroll 50 participants.