NCT05340491 Chemoradiotherapy Plus Anti-PD1 in Recurrent NPC: A Multicenter, Open-label, Randomised, Controlled, Phase III Trial
| NCT ID | NCT05340491 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Sun Yat-sen University |
| Condition | Nasopharyngeal Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 212 participants |
| Start Date | 2022-04-01 |
| Primary Completion | 2026-12 |
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 212 participants in total. It began in 2022-04-01 with a primary completion date of 2026-12.
⚠ 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 is a multicenter, open-label, randomized, controlled, phase III trial. The purpose of this trial is to evaluate the efficacy and toxicity of anti-PD-1 antibody combined with chemoradiotherapy versus chemoradiotherapy alone in recurrent nasopharyngeal carcinoma patients.
Eligibility Criteria
Inclusion Criteria: * Diagnosed as local with or without regional recurrence after ≥1 year of radical treatment; * Not suitable for surgery; * Histologic diagnosis of NPC (WHO II/III); * TNM stage rII-IVa (AJCC/UICC 8th); * ECOG 0-1 point; * No treatment to rNPC prior, such as radiotherapy, chemotherapy, immunotherapy or biotherapy; * No contraindications to immunotherapy or chemoradiotherapy; * Adequate marrow function: WBC count ≥ 3×10E9/L, NE count ≥ 1.5×10E9/L, HGB ≥ 90g/L, PLT count ≥ 100×10E9/L; * Adequate liver function: ALT/AST ≤ 2.5×ULN, TBIL ≤ 2.0×ULN; * Adequate renal function: BUN/CRE ≤ 1.5×ULN or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula); * Take effective contraceptions during and two months after treatment; * Patients must be informed of the investigational nature of this study and give written informed consent. Exclusion Criteria: * Treated with anti-tumor Chinese medicine treatment; * Have recurrence with local necrosis; * Have ≥G3 late toxicities, except for skin, subcutaneous tissue or mucosa; * Unexplained fever \> 38.5, except for tumor fever; * Treated with ≥ 5 days antibiotics one month before enrollment; * Have active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy); Have a known history of human immunodeficiency virus (HIV), active Hepatitis B (HBV-DNA ≥10E3copiers/ml) or hepatitis C virus (HCV) antibody positive; Have previously treated with PD-1 antibody or other immunotherapy for PD-1/PD-L1 pathway; * Have New York Heart Association (NYHA) class 3 or 4, unstable angina, myocardial -infarction within 1 year, or clinically meaningful arrhythmia that requires treatment; * Have known allergy to large molecule protein products or any compound of study therapy; * Pregnant or breastfeeding; * Prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical cancer, and papillary thyroid carcinoma; * Have received a live vaccine within 30 days of planned start of study therapy Has psychiatric drug or substance abuse disorders that would interfere with cooperation with the requirements of the trial; * Any other condition, including 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
Chong Zhao, MD PhD
PRINCIPAL INVESTIGATOR
Sun Yat-Sen University Cancer Center
Frequently Asked Questions
Who can join the NCT05340491 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 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 NCT05340491 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 212 participants.
Is NCT05340491 currently recruiting?
Yes, NCT05340491 is actively recruiting participants. Contact the research team at miaojj@sysucc.org.cn for enrollment information.
Where is the NCT05340491 trial being conducted?
This trial is being conducted at Guangzhou, China, Beijing, China, Chengdu, China, Fuzhou, China and 8 additional locations.
Who is sponsoring the NCT05340491 clinical trial?
NCT05340491 is sponsored by Sun Yat-sen University. The principal investigator is Chong Zhao, MD PhD at Sun Yat-Sen University Cancer Center. The trial plans to enroll 212 participants.