PD-1 Antibody Combined With Chemoradiotheapy vs. Chemoradiotherapy in Recurrent Nasopharyngeal Carcinoma Patients: a Multicenter, Randomised Controlled, Phase III Clinical Trial
Overview
- Phase
- Phase 3
- Intervention
- GP
- Conditions
- Recurrent Nasopharyngeal Carcinoma
- Sponsor
- Sun Yat-sen University
- Enrollment
- 212
- Locations
- 12
- Primary Endpoint
- Overall survival
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
This is a multicenter, randomized controlled, phase III clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of PD-1 antibody with chemoradiotherapy versus chemoradiotherapy alone in recurrent nasopharyngeal carcinoma patients.
Investigators
Zhao Chong
Prof.
Sun Yat-sen University
Eligibility Criteria
Inclusion Criteria
- •Diagnosed as local recurrence ± regional recurrence after ≥1 year of radical treatment;
- •Not suitable for surgery;
- •Newly histologic diagnosis of NPC (WHO II/III);
- •Clinical stage rII-IVa (AJCC/UICC 8th);
- •ECOG 0-1 point;
- •No treatment to rNPC, such as radiotherapy, chemotherapy, immunotherapy or biotherapy;
- •No contraindications to immunotherapy or radiotherapy;
- •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);
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 ≥10E4copiers/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;
Arms & Interventions
PD-1 antibody plus chemoradiotherapy
Patients randomized to this arm will receive three cycles of PD-1 antibody (JS001, 240mg every three weeks) combined with GP chemotherapy, then receive IMRT and PD-1 antibody maintenance for eight cycles.
Intervention: GP
PD-1 antibody plus chemoradiotherapy
Patients randomized to this arm will receive three cycles of PD-1 antibody (JS001, 240mg every three weeks) combined with GP chemotherapy, then receive IMRT and PD-1 antibody maintenance for eight cycles.
Intervention: PD-1 blocking antibody
PD-1 antibody plus chemoradiotherapy
Patients randomized to this arm will receive three cycles of PD-1 antibody (JS001, 240mg every three weeks) combined with GP chemotherapy, then receive IMRT and PD-1 antibody maintenance for eight cycles.
Intervention: IMRT
Chemoradiotherapy
Patients randomized to this arm will receive three cycles of GP chemotherapy, then receive IMRT alone.
Intervention: GP
Chemoradiotherapy
Patients randomized to this arm will receive three cycles of GP chemotherapy, then receive IMRT alone.
Intervention: IMRT
Outcomes
Primary Outcomes
Overall survival
Time Frame: 3 years
From date of randomisation to death
Secondary Outcomes
- Progression free survival(3 years)
- Short-term effects(through study completion, an average of 2 months)
- Rate of patients with acute toxicities(through study completion, an average of 2 months)
- Quality of life: EuroQoL 5 dimension(through whole study, an average of 3 years)