Recurrent Nasopharyngeal Carcinoma
Conditions
Keywords
PD-1 antibody, Intensity-modulated Radiation Therapy, Chemotherapy, Efficacy, Adverse effects
Brief summary
This is a a prospective, single-arm phase II clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of PD-1 antibody with chemotherapy in high-risk recurrent nasopharyngeal carcinoma.
Interventions
Toripalimab is an antibody targeting PD-1 developed by Shanghai Junshi Biosciences Co., Ltd.
DRUGChemotherapy
Cisplatin and Gemcitabine
RADIATIONIMRT
IMRT 60-66Gy, 1.8-2.0Gy/f/day
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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; * PRANCIS score \> 252 points; * No treatment to rNPC, 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
* 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 | 2 years | From date of recruitment to death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | After 3 cycles of GP chemothrapy plus PD-1 antibody (each cycle is 21 days) | Patient's short-term effect |
| Disease control rate | After 3 cycles of GP chemothrapy plus PD-1 antibody (each cycle is 21 days) | Patient's short-term effect |
| Progression free survival | 2 years | From date of recruitment to disease progression or death |
| Adverse effects | through study completion, an average of 3 months | Evaluating with CTCAE v5.0 |
| Quality of life: EuroQoL 5 dimension | through whole study, an average of 2 years | Evaluating with questionnaire of EuroQoL 5 dimension, 5 level health state utility index (EQ-5D-5L) |
Countries
China
Outcome results
None listed