Recurrent Nasopharyngeal Carcinoma Clinical Trial
Official title:
PD-1 Antibody Combined With Chemotherapy in High-risk Recurrent Nasopharyngeal Carcinoma: a Prospective, Open, Single-arm Phase II Clinical Trial
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.
Status | Recruiting |
Enrollment | 68 |
Est. completion date | December 2025 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Sun Yat-sen University Cancer Center | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-sen University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival | From date of recruitment to death | 2 years | |
Secondary | Objective response rate | Patient's short-term effect | After 3 cycles of GP chemothrapy plus PD-1 antibody (each cycle is 21 days) | |
Secondary | Disease control rate | Patient's short-term effect | After 3 cycles of GP chemothrapy plus PD-1 antibody (each cycle is 21 days) | |
Secondary | Progression free survival | From date of recruitment to disease progression or death | 2 years | |
Secondary | Adverse effects | Evaluating with CTCAE v5.0 | through study completion, an average of 3 months | |
Secondary | Quality of life: EuroQoL 5 dimension | Evaluating with questionnaire of EuroQoL 5 dimension, 5 level health state utility index (EQ-5D-5L) | through whole study, an average of 2 years |
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