Status:
RECRUITING
Chemoradiotherapy Plus Anti-PD1 in Recurrent NPC: A Multicenter, Open-label, Randomised, Controlled, Phase III Trial
Lead Sponsor:
Sun Yat-sen University
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 ver...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT05340491
Start Date
April 1 2022
End Date
December 1 2027
Last Update
August 31 2022
Active Locations (12)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
2
Peking University Third Hospital
Beijing, China
3
Sichuan Cancer Hospital
Chengdu, China
4
Fujian Province Cancer Hospital
Fuzhou, China