| Eligibility |
Inclusion Criteria:
- 1. 18-70 years old, no gender limit;
- 2. Oligo metastasis is defined as less than or equal to 5 metastatic lesions and less
than or equal to 2 metastatic organs
- 3. Patients with an ECOG score of 0 or 1, and an expected survival period of =6
months;
- 4. Has good organ function:
1. Hematology: WBC>3.0×109/L; ANC>1.5×109/L; Hb>90g/L; PLT>100×109/L; Albumin
=3g/dL;
2. Liver function: bilirubin = 1.5 times the upper limit of normal (ULN) (patients
with known Gilbert disease and serum bilirubin level = 3 times ULN can be
included), AST and ALT = 3 times ULN (if liver metastases occur , Then AST/ALT=5
times ULN), and alkaline phosphatase=3 times ULN (if liver or bone metastasis
occurs, ALP=5 times ULN); (3) Coagulation function: International normalized
ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time
(APTT) = 1.5 times ULN; (4)Renal function: According to the Cockcroft-Gault
formula (Appendix 8), serum creatinine =1.5 times ULN or creatinine clearance
=60mL/min.
- 5. Female subjects have a negative pregnancy test (for female patients with
fertility); female patients without fertility;
- 6. Male patients with fertility and female patients with fertility and risk of
pregnancy must agree to take adequate contraceptive measures throughout the study
period, and contraception lasts for 12 months after receiving this program.
- 7. Patients who are willing and able to comply with visit arrangements, treatment
plans, laboratory tests and other research procedures;
- 8. During the research period, they are willing to comply with the arrangement and
cannot participate in any other clinical research on drugs and medical devices;
- 9. For patients who have previously received neoadjuvant chemotherapy, adjuvant
chemotherapy, radiotherapy or radiotherapy for non-metastatic diseases, the time from
the last chemotherapy and/or radiotherapy to randomization must reach a non-treatment
interval of = 6 months . Oral S1 and capecitabine have no requirement for treatment
interval for those who are progressing during chemotherapy.
- 10. The patients sign a formal informed consent form to show that they understand that
this study complies with the hospital's policies
Exclusion Criteria:
- 1. Those who have a history of severe immediate hypersensitivity to any of the drugs
used in this study;
- 2. Suffered from other malignant tumors other than nasopharyngeal carcinoma within 5
years (except for tumors with an expected 5-year OS>90%, such as non-melanoma skin
cancer or pre-invasive cervical cancer);
- 3. Any of the following conditions in the 6 months before screening: myocardial
infarction, severe/unstable angina, coronary artery/peripheral artery bypass graft,
symptomatic congestive heart failure, cerebrovascular accident, transient cerebral
ischemia Onset or symptomatic pulmonary embolism. Patients with known coronary artery
disease, congestive heart failure that does not meet the above criteria, or left
ventricular ejection fraction <50% must adopt an optimized and stable medical plan
determined by the treating doctor. If appropriate, you can consult a cardiologist;
- 4. Have received any of the following treatments:
1. Have received anti-PD-1 or anti-PD-L1 antibody therapy in the past;
2. Have received any investigational drug within 4 weeks before using the
investigational drug for the first time;
3. A large number of glucocorticoids or other immunosuppressants (including but not
limited to prednisone, dexamethasone, azathioprine, methotrexate, thalidomide,
and anti-tumor necrosis factor) have been used in the 4 weeks before treatment
Subjects with anti-TNF drugs, or subjects in need of hormone therapy during
clinical trials. Other special circumstances require communication with the
sponsor. In the absence of active autoimmune diseases, inhaled or topical
steroids and adrenal cortex hormones with a dose> 10 mg/day of prednisone are
allowed to be substituted;
4. Those who have been vaccinated with anti-tumor vaccines or the study drug has
been vaccinated with live vaccines within 4 weeks before the first
administration;
5. Have undergone major surgery or severe trauma within 4 weeks before using the
study drug for the first time;
6. Enroll in another clinical study at the same time, unless it is an observational
(non-interventional) clinical study or an interventional clinical study
follow-up;
- 5. Patients with active autoimmune disease or a history of autoimmune disease but may
relapse. Remarks: Patients with the following diseases are not excluded and can enter
further screening:
1. Controlled type 1 diabetes
2. Hypothyroidism (if only hormone replacement therapy can be used to control)
3. Skin diseases that do not require systemic treatment (such as vitiligo,
psoriasis, hair loss)
4. Any other diseases that are not expected to recur without external triggers
- 6. Active infections, including tuberculosis, hepatitis B, hepatitis C and human
immunodeficiency virus. Patients with positive HBV surface antigen (HBsAg) but HBV DNA
<1000 copies/mL are eligible to participate in this study; patients with positive HCV
antibody test results are only allowed if the HCV RNA polymerase chain reaction test
results are negative. Be selected for this study;
- 7. Idiopathic pulmonary fibrosis, drug-induced pneumonia, organizing pneumonia
(bronchiolitis obliterans), idiopathic pneumonia, or chest CT scan at the time of
screening shows evidence of active pneumonia;
- 8. Drug abuse or alcohol addiction;
- 9. No capacity for civil conduct or limited capacity for civil conduct;
- 10. The patient has a physical or mental illness, and the researcher believes that the
patient cannot fully or fully understand the possible complications of this study;
- 11. Other serious acute or chronic medical conditions (including immune colitis,
inflammatory diseases, Enteropathy, non-infectious pneumonia, pulmonary fibrosis) or
mental illness (including dementia and epilepsy, recent, past year or active suicidal
ideation or behavior) or abnormal laboratory tests;
- 12. Patients whose expected survival time is less than 6 months;
- 13. Patients with significantly reduced heart, liver, lung, kidney and bone marrow
functions
- 14. Previously diagnosed as immunodeficiency or known human immunodeficiency virus
(HIV) or acquired immunodeficiency syndrome (AIDS) related diseases;
- 15. Female patients during pregnancy or lactation, male or female patients who are
fertile but are unwilling or unable to use contraception during the entire study
period and at least one year after the end of the treatment plan;
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