This is a prospective, single-arm, phase II clinical trial. The purpose of this study isto evaluate the efficacy and adverse effect of SBRT and LDRT combined with programmeddeath 1 (PD-1) antibody and chemotherapy in recurrent/metastatic nasopharyngeal carcinomapatients.
Not Provided
Radiation: SBRT
SBRT for metastatic lesions
Radiation: Low-dose Radiotherapy (LDRT)
LDRT for metastatic lesions
Drug: Toripalimab
6 cycles for combined therapy. Toripalimab maintenance for 1 year.
Drug: Gemcitabine
6 cycles for combined therapy.
Drug: Cisplatin
6 cycles for combined therapy.
Radiation: IMRT
IMRT for primary lesion
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.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Investigator: Chong Zhao, M.D
Contact: 02087342638
zhaochong@sysucc.org.cn
Jingjing Miao, MD.
13631355201
miaojj@sysucc.org.cn
Chong Zhao, MD. PhD.
+8687342638
zhaochong@sysucc.org.cn
Chong Zhao, MD. PhD., Principal Investigator
Sun Yat-sen University