Overview

Chemoradiotherapy Plus Anti-PD1 in Recurrent NPC: A Multicenter, Open-label, Randomised, Controlled, Phase III Trial

Status:
Recruiting
Trial end date:
2027-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sun Yat-sen University
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.