Nasopharyngeal Carcinoma
Conditions
Keywords
locoregional relapse, nasopharyngeal carcinoma, chemoradiotherapy, PD-1 antibody, efficacy, toxicity
Brief 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.
Interventions
DRUGToripalimab
240mg, D1, every 3 weeks per cycle, three cycles with chemotherapy and eight cycles after IMRT
DRUGChemotherapy
Gemcitabine: 1.0g/m2, D1 and D8, Cisplatin 80mg/m2, D1, every 3 weeks per cycle, total three cycles
RADIATIONIntensity modulated radiotherapy
total 60-66Gy, 1.8-2.0Gy/f/day
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | three years | Defined as the time from date of recruitment to death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Failure-free survival | three years | Defined as the time from date of recruitment to documented relapse or death from any cause. |
| Objective response rate through study completion, an average of nine months | through study completion, an average of nine months | The rate of patients get CR or PR after treatment |
| Disease control rate through study completion, an average of nine months | through study completion, an average of nine months | The rate of patients get CR or PR or SD after treatment |
| Incidence of nasopharyngeal necrosis and hemorrhage up to 3 years | up to three-year follow-up | Incidence of nasopharyngeal necrosis and hemorrhage after receiving treatment |
| Acute toxicities were graded using the Common Toxicity Criteria for Adverse Events version 5.0 (CTCAE v5.0) | through study completion, an average of nine months | Acute toxicities were graded using the Common Toxicity Criteria for Adverse Events version 5.0 (CTCAE v5.0) for chemotherapy and immunotherapy-specific toxicities, and the Radiation Therapy Oncology Group (RTOG) radiation morbidity scoring criteria for radiotherapy-specific toxicities. |
| Late toxicity | three years | Late toxicities were assessed annually using the RTOG radiation morbidity scoring criteria. |
| Quality of life through study completion, up to 3 years | up to three-year follow-up | Evaluated with questionnaire of EuroQoL 5 dimension, 5 level health state utility index (EQ-5D-5L). |
Countries
China
Contacts
CONTACTJingjing Miao, PhD
PRINCIPAL_INVESTIGATORChong Zhao, MD PhD
Sun Yat-Sen University Cancer Center
Outcome results
None listed