| Eligibility |
Inclusion Criteria:
- The subjects voluntarily joined the study, signed the informed consent form, and had
good compliance.
- Between the ages of 18-75 years (calculated based on the date of signing ICF); male or
female; Eastern cooperative oncology group (ECOG) score 0-1; estimated survival time =
3 months.
- No indications of local radical therapy for recurrence/metastasis head and neck
squamous cell carcinoma.And histologically- or cytologically-confirmed head and neck
squamous cell carcinoma ,Primary tumor locations of oropharynx, oral cavity,
hypopharynx, or larynx.
- No systemic therapy for recurrent/metastatic lesions, but excluding systemic therapy
for locally advanced disease as a part of multimodal therapy (including induction
therapy, systemic therapy in the same period of radiotherapy, and adjuvant therapy),
and the completion time of treatment was more than 6 months from enrollment (according
to the date of informed consent);
- At least one measurable lesion (based on RECIST1.1).
- The main organs function are normally, the following criteria are met:
1. hemoglobin (Hb) =90g/L (no blood transfusion and blood products within 14 days)
;absolute neutrophil count (ANC) =1.5×109/L; platelets (PLT) =90×109/L.
2. Total bilirubin (TBIL) = 1.5 times the upper limit of normal value (ULN); Alanine
aminotransferase (ALT) and aspartate aminotransferase (AST) =2.5×ULN. If
accompanied by liver metastases, ALT and AST = 5×ULN; Serum creatinine (CR) =
1.5×ULN or creatinine clearance (CCR) = 60 ml/min.
3. Prothrombin time (PT), activated partial thromboplastin time (APTT),
international normalized ratio (INR) = 1.5×ULN (no anticoagulant therapy);
Thyroid-stimulating hormone (TSH) = ULN; If abnormalities should be examined, T3
and T4 levels should be examined, and T3 and T4 levels are normal.
4. Cardiac ultrasound assessment: left ventricular ejection fraction (LVEF) = 50%.
- Female participants of childbearing age should agree to use contraception (e.g., IUDs,
pills, or condoms) during the study period and for 6 months after the end of the
study; Have a negative serum pregnancy test within 7 days prior to study enrollment
and must be a non-lactating subject; Male participants should agree that contraception
must be used during the study period and for 6 months after the end of the study
period.
Exclusion Criteria:
- Comorbidity and medical history:
1. Have had or currently have other malignant tumors within 3 years. The following
two conditions can be enrolled: other malignancies treated with a single surgery
to achieve 5-year disease-free survival (DFS); cured cervical carcinoma in situ,
non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive
tumors), Tis (carcinoma in situ) and T1 (tumor-invasive basement membrane)];
2. adverse effects due to any prior treatment have not been restored to CTCAE 5.0 =
level 1 (except for toxicity where the investigator determines that there is no
safety risk);
3. Major surgical treatment, incision biopsy, or significant traumatic injury were
received within 28 days prior to study treatment
4. Long-term unhealed wounds or fractures
5. Arteriovenous thrombotic events within 6 months, such as cerebrovascular
accidents;
6. Those who have a history of psychotropic substance abuse and cannot quit or have
a mental disorder;
7. Subjects with any severe and/or uncontrolled medical conditions, including:
1. Unsatisfactory blood pressure control (systolic blood pressure = 150mmHg or
diastolic blood pressure =100 mmHg);
2. Have grade =2 myocardial ischemia or myocardial infarction, arrhythmias
(including QTc = 450 ms (male) in men and QTc = 470 ms (female)) and grade =
congestive heart failure grade 2 (New York Heart Association (NYHA) grade);
3. Active or uncontrolled severe infection (= CTC AE grade 2 infection) or
unexplained fever > 38.5°C;
4. Liver cirrhosis, active hepatitis Note: Active hepatitis (hepatitis B
reference: HBsAg positive and HBV (hepatitis B virus) DNA detection value of
more than 1000 copies /mL; Hepatitis C reference: HCV (hepatitis C virus)
antibody positive, and HCV virus titer test value above the upper limit of
normal);
5. Known to have syphilis;
6. Renal failure requires hemodialysis or peritoneal dialysis
7. A history of immunodeficiency, including HIV positive or other acquired or
congenital immunodeficiency diseases, or a history of organ transplantation;
8. Poor diabetes control [fasting blood glucose (FBG) > 10mmol/L]
9. Urine routine indicated urine protein =++, and confirmed 24 hours urine
protein quantity > 1.0 g
10. People who have epilepsy and need treatment
- Tumor related symptoms and treatment
1. Study history of surgery, chemotherapy, radiotherapy, or other anticancer therapy
within 4 weeks prior to the start of treatment (washout period from the end of
the last treatment);
2. progress during or within 6 months of completion of systemic therapy (including
induction therapy, concurrent radiotherapy, adjuvant therapy) for locally
advanced disease;
3. Secondary radiotherapy was performed for local recurrent lesions;
4. Received Chinese patent drugs with anti-tumor indications specified in the
Chinese National Medical Product Administration approved drug instructions within
1 week before the study treatment;
5. Have received relevant immunotherapy drugs in the past;
6. where imaging (CT or MRI) shows that the tumor has invaded important blood
vessels, or the investigator determines that the tumor is highly likely to invade
important blood vessels and cause fatal massive bleeding during the follow-up
study period;
7. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring
repeated drainage (investigator's judgment)
8. Subjects with known central nervous system metastatic and/or cancerous
meningitis;
- Research and treatment related:
1. Study history of live attenuated vaccine vaccination within 28 days before the
start of treatment or planned live attenuated vaccine vaccination during the
study period;
2. Patients with a definite tendency to bleed or clinically significant bleeding
symptoms, including but not limited to gastrointestinal bleeding, nasal bleeding,
and hemorrhagic disease or coagulopathy within 28 days prior to initial
medication;
3. People who have experienced severe hypersensitivity after the use of monoclonal
antibodies, or are allergic to known components of the drug under study;
4. Study of active autoimmune diseases requiring systemic treatment that occurred
within 2 years prior to initiation of treatment;
5. Have been diagnosed with immunodeficiency or are receiving systemic
glucocorticoid therapy or any other form of immunosuppressive therapy (dose >
10mg/ day prednisone or other efficacy hormone) and continue to use within 2
weeks before the study therapy begins;
- Participated in clinical trials of other antitumor drugs within 4 weeks before the
first medication;
- Subjects who, in the judgment of the investigator, have concomitant diseases that
seriously endanger the safety of the subjects or affect the completion of the study,
or subjects who are not suitable for inclusion for other reasons.
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