PD-1 Antibody Versus Best Supportive Care After Chemoradiation in Locoregionally Advanced Nasopharyngeal Carcinoma
- Registration Number
- NCT03427827
- Lead Sponsor
- Sun Yat-sen University
- Brief Summary
This trial is aimed to investigate whether adjuvant PD-1 antibody treatment could improve survival in locoregionally advanced nasopharyngeal carcinoma compared to best supportive care.
- Detailed Description
In this multicenter, randomised controlled, phase 3 trial, patients with stage III-IVA (AJCC/UICC 8th system, except T3-4N0 and T3N1) non-metastatic nasopharyngeal carcinoma will be randomized in a 1:1 ratio to recieve PD-1 antibody for 12 doses every 3 weeks or best supportive care after curative chemoradiation.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 450
- Patients with histologically confirmed nasopharyngeal carcinoma.
- Tumor staged as III-IVA (AJCC 8th, except T3N0-1 or T4N0).
- Completed protocol-specified curative chemoradiotherapy, including gemcitabine and cisplatin induction chemotherapy, intensity-modulated radiotherapy, and concurrent cisplatin chemotherapy.
- Completion of the last radiation dose within 1 to 42 days before randomization
- Eastern Cooperative Oncology Group performance status ≤1.
- Adequate marrow function: neutrocyte count≥1.5×10e9/L, hemoglobin ≥90g/L and platelet count ≥100×10e9/L.
- Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) ≤2.5×upper limit of normal (ULN), and bilirubin ≤ 1.5×ULN.
- Adequate renal function: creatinine clearance rate ≥ 60 ml/min (Cockcroft-Gault formula).
- Patients must be informed of the investigational nature of this study and give written informed consent.
- Women of childbearing potential (WOCBP) who are sexually active must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of study drug. Men who are sexually active with WOCBP must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of the study drug.
- Age > 65 or < 18.
- Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus DNA >1×10e3 copies/ml or 200IU/ml
- Hepatitis C virus (HCV) antibody positive
- Has active autoimmune disease, except type I diabetes, hypothyroidism treated with replacement therapy, and skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia).
- Has any condition that required systemic corticosteroid (equivalent to prednisone >10mg/d) or other immunosuppressive therapy within 28 days before informed consent. Patients received systemic corticosteroid equivalent to prednisone ≤10mg/d, inhale or topical corticosteroid will be allowed.
- Has a known history of active TB (bacillus tuberculosis) within 1 year; patients with adequately treated active TB over 1 year ago will be allowed.
- Has a known history of interstitial lung disease.
- Has received a live vaccine within 30 days before informed consent or will receive a live vaccine in the near future.
- Is pregnant or breastfeeding.
- Prior malignancy within 5 years, except in situ cancer, adequately treated non-melanoma skin cancer, and papillary thyroid carcinoma.
- Has known allergy to large molecule protein products or any compound of camrelizumab.
- Has a known history of human immunodeficiency virus (HIV) infection.
- Any other condition, including symptomatic heart failure, unstable angina, myocardial infarction, active infection requiring systemic therapy, 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Adjuvant PD-1 antibody arm Camrelizumab Patients randomized to this arm will receive PD-1 antibody (SHR-1210), 200mg, ivdrip (\>30 minutes), d1, q3w × 12 cycles, begining at 4-6 weeks after chemoradiation
- Primary Outcome Measures
Name Time Method failure-free survival 3 years calculated from the date of randomisation to the date of locoregional failure, distant failure, or death from any cause, whichever occurred first.
- Secondary Outcome Measures
Name Time Method distant metastasis-free survival 3 years calculated from date of randomisation to the first distant failure
locoregional recurrence-free survival 3 years calculated from date of randomisation to the first locoregional failure
adverse events (AEs) and severe adverse events (SAE) 3 years graded according to NCI CTCAE v5.0
overall survival 5 years calculated from date of randomisation to death
quality of life (QoL) 3 years the change of QoL from randomization to 36 months after chemoradiation, graded according to EORTC QLQ-C30 V3.0
Trial Locations
- Locations (11)
Xiangya Hospital Central South University
🇨🇳Changsha, Hunan, China
First People's Hospital of Foshan
🇨🇳Foshan, Guangdong, China
Guangzhou Medical University Cancer Hospital
🇨🇳Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Panyu central hospital
🇨🇳Guangzhou, Guangdong, China
Cancer Hospital of Guangxi Medical University
🇨🇳Nanning, Guangxi, China
Cancer Hospital of Guizhou Medical University
🇨🇳Guiyang, Guizhou, China
Xijing Hospital, Fourth Military Medical University
🇨🇳Xi'an, Shanxi, China
West China Hospital, Sichuan University
🇨🇳Chengdu, Sichuan, China
Tongji Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China