Chemoradiotherapy Plus Anti-PD1 in Recurrent NPC: A Multicenter, Open-label, Randomised, Controll… (NCT05340491) | Clinical Trial Compass
RecruitingPhase 3
Chemoradiotherapy Plus Anti-PD1 in Recurrent NPC: A Multicenter, Open-label, Randomised, Controlled, Phase III Trial
China212 participantsStarted 2022-04-01
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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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; Hav…