Nasopharyngeal Carcinoma
Conditions
Keywords
SBRT, Low-dose radiotherapy, PD-1 antibody, Chemotherapy
Brief summary
This is a prospective, single-arm, phase II clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of SBRT and LDRT combined with programmed death 1 (PD-1) antibody and chemotherapy in recurrent/metastatic nasopharyngeal carcinoma patients.
Interventions
RADIATIONSBRT
SBRT for metastatic lesions
RADIATIONLow-dose Radiotherapy (LDRT)
LDRT for metastatic lesions
DRUGToripalimab
6 cycles for combined therapy. Toripalimab maintenance for 1 year.
DRUGGemcitabine
6 cycles for combined therapy.
DRUGCisplatin
6 cycles for combined therapy.
RADIATIONIMRT
IMRT for primary lesion
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 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed as recurrence/metastatic NPC * Histopathological diagnosis of NPC(WHO II/III) * ECOG 0-1 point * No treatment to r/mNPC, such as radiotherapy, chemotherapy, immunotherapy or biotherapy; * No contraindications to immunotherapy and chemoradiotherapy; * At least one lesion could receive SBRT safely; * Subject must have a measurable target lesion based on RECIST v1.1; * 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 three months after treatment; * Patients must be informed of the investigational nature of this study and give written informed consent.
Exclusion criteria
* Allergic to monoclonal antibodies, any PD-1 antibody components, gemcitabine and cisplatin; * Unexplained fever \> 38.5 #, except for tumor fever; * 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 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 |
|---|---|---|
| Progression-free survival | up to 12 months | Defined as the time from randomization to the first occurrence of disease progression as determined according to RECIST v1.1 or death from any cause, whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | up to 12 months | Defined as the time from randomization to death from any cause. |
| Objective Response Rate | up to 12 months | The percentage of patients with CR and PR assessed according to RECIST v1.1. |
| Disease Control Rate | up to 12 months | The proportion of patients who have achieved complete response, partial response and stable disease according to RECIST v1.1. |
| Adverse Events | up to 12 months | All adverse event or serious adverse event that occurred during the study period according to CTCAE v 4.03 |
| QoL | up to 12 months | Assessed by EQ-5D-5L questionnaire |
Countries
China
Contacts
CONTACTJingjing Miao, MD.
CONTACTChong Zhao, MD. PhD.
PRINCIPAL_INVESTIGATORChong Zhao, MD. PhD.
Sun Yat-sen University
Outcome results
None listed