NCT04453826 Concurrent and Adjuvant PD1 Treatment Combined With Chemo-radiotherapy for High-risk Nasopharyngeal Carcinoma
| NCT ID | NCT04453826 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Sun Yat-sen University |
| Condition | Nasopharyngeal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 388 participants |
| Start Date | 2020-09-01 |
| Primary Completion | 2026-09 |
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.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 388 participants in total. It began in 2020-09-01 with a primary completion date of 2026-09.
⚠ 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
Through multicenter, open-label, randomised clinical trials, we intend to demonstrate that concurrent and adjuvant PD-1 treatment added to chemo-radiotherapy could further decrease the rate of disease progression and improve the survival outcome of high risk patients with nasopharyngeal carcinoma compared with those treated with chemo-radiotherapy alone.
Eligibility Criteria
Inclusion Criteria: 1. Histologically confirmed non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated type, i.e., WHO type II or type III). 2. Staged as T4N0-2M0,T1-4N3M0 (stage IVa) at diagnosis (according to the 8th AJCC edition). 3. Staged as T1-3N1-2M0, T2-3N0M0 (stage II-III) with SD/PD according to RECIST criteria or EBV DNA of \>0 copies/mL after 3 cycles of GP induction chemotherapy. 4. Aged between 18-70 years. 5. Karnofsky scale (KPS)≥70. 6. Normal bone marrow function. 7. Normal liver and kidney function: 1. total bilirubin, AST and ALT levels of no more than 2.5 times the upper normal limit; 2. creatinine clearance rate of at least 60 mL/min or creatinine of no more than 1.5 times the upper normal limit. 8. Given written informed consent. Exclusion Criteria: 1. Histologically confirmed keratinized squamous cell carcinoma (WHO type I) or basal squamous cell carcinoma. 2. Recurrent or metastatic nasopharyngeal carcinoma. 3. Staged as II-III which is evaluated as PR or CR and EBV DNA of 0 copies/mL after 3 cycles of GP induction chemotherapy. 4. Has known allergy to large molecule protein products or any compound of study therapy. 5. Has known subjects with other malignant tumors. 6. Has any active autoimmune disease or history of autoimmune disease. 7. Has a history of psychiatric substance abuse, alcoholism, or drug addiction. 8. The laboratory examination value does not meet the relevant standards within 7 days before enrollment 9. Received a systematic glucocorticoid therapy within 4 weeks of the first dose of study medication. 10. Has a known history of active TB (bacillus tuberculosis) within 1 year; patients with adequately treated active TB with 1 year. 11. Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or CTLA-4 agent. 12. Has active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy). Patients with skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia) will be allowed to enroll. 13. Has a known history of human immunodeficiency virus (HIV). 14. Has hepatitis B surface antigen (HBsAg) positive with HBV DNA copy number of ≥1000cps/ml or hepatitis C virus (HCV) antibody positive. 15. Has received a live vaccine within 4 weeks of planned start of study therapy. 16. Pregnancy or breast feeding.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04453826 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Nasopharyngeal Cancer. 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 NCT04453826 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 388 participants.
Is NCT04453826 currently recruiting?
Yes, NCT04453826 is actively recruiting participants. Contact the research team at chmingy@mail.sysu.edu.cn for enrollment information.
Where is the NCT04453826 trial being conducted?
This trial is being conducted at Guangzhou, China, Guangzhou, China, Shaoguan, China, Zhongshan, China and 2 additional locations.
Who is sponsoring the NCT04453826 clinical trial?
NCT04453826 is sponsored by Sun Yat-sen University. The trial plans to enroll 388 participants.
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