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

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Sun Yat-sen University

Status and phase

Enrolling
Phase 3

Conditions

Nasopharyngeal Carcinoma

Treatments

Drug: Chemotherapy
Drug: Toripalimab
Radiation: Intensity modulated radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT05340491
B2022-111-01

Details and patient eligibility

About

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.

Enrollment

212 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

212 participants in 2 patient groups

Chemoradiotherapy+anti-PD-1
Experimental group
Description:
Patients in this arm will receive three cycles of GP chemotherapy plus PD-1 antibody, then receive IMRT and PD-1 antibody maintenance for eight cycles.
Treatment:
Radiation: Intensity modulated radiotherapy
Drug: Toripalimab
Drug: Chemotherapy
Chemoradiotherapy
Active Comparator group
Description:
Patients in this arm will receive three cycles of GP chemotherapy, then receive IMRT.
Treatment:
Radiation: Intensity modulated radiotherapy
Drug: Chemotherapy

Trial contacts and locations

12

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Central trial contact

Jingjing Miao, PhD

Data sourced from clinicaltrials.gov

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