Camrelizumab Plus Docetaxel and Cisplatin in Recurrent or Metastatic Oral Squamous Cell Carcinoma Patients

Inclusion Criteria:

• Patients with histologically confirmed post-surgical recurrent/metastatic or locallyadvanced inoperable oral squamous carcinoma with measurable lesions (spiral CT scan ≥ 10 mm, meeting RECIST 1.1 criteria).
• No prior treatment with any systemic antineoplastic agent, prior adjuvant orneoadjuvant therapy (other than PD-1/PDL-1 monoclonal antibody) is allowed, providedthat it was completed at least 4 weeks prior to the first dose of study drug and allassociated toxic events have returned to normal or to grade I or below as defined byCTCAE 4.03 classification.
• An ECOG score of 0 or 1.
• Expected survival of ≥ 12 weeks.
• Normal function of major organs within 2 weeks prior to treatment, i.e. meeting thefollowing criteria. Bone marrow function: hemoglobin ≥ 100gg/L, white blood cell count ≥ 4.010^9/L orneutrophil count ≥ 2.010^9/L and platelet count ≥ 100*10^9/L without transfusion or withcolony-stimulating factor support therapy. Liver: serum total bilirubin level ≤ 1.5 times the upper limit of normal, aspartateaminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5 times the upper limit ofnormal. Renal: blood creatinine level less than 1.5 times the upper limit of normal or creatinineclearance ≥ 60 ml/min and urea nitrogen ≤ 200 mg/L. Urine protein <+, if urine protein +then total 24 hour protein must be <500mg. Blood glucose: within normal range and/or with diabetic patients on treatment but withstable blood glucose control. Pulmonary function: baseline FEV1 of at least 2L, if baseline FEV1 < 2L, FEV1 >800ml isexpected after surgery as assessed by a surgical specialist. Cardiac function: no myocardial infarction within 1 year; no unstable angina; nosymptomatic severe arrhythmia; no cardiac insufficiency.
• Women of childbearing potential must have a negative serum pregnancy test resultwithin 7 days prior to the first dose of the test drug; men of childbearing potentialor women of childbearing potential must use a highly effective contraceptive method (e.g., oral contraceptive pill, intrauterine device, abstinence from sexualintercourse, or barrier contraceptive method combined with spermicide) throughout thetrial and continue to use contraception for 12 months after the end of treatment.

Exclusion Criteria:

• Patients with prior anti-PD-1, anti-PD-L1, anti-PD-L2 therapy. Patients who arecurrently receiving antineoplastic therapy.
• Patients who have participated or are participating in a clinical trial of anotherdrug/therapy within 4 weeks prior to the first dose of the study drug.
• Patients with any active autoimmune disease or history of autoimmune disease (e.g.,the following, but not limited to: autoimmune hepatitis, interstitial pneumonia,uveitis, enterocolitis, hepatitis, pituitary inflammation, vasculitis, nephritis,hyperthyroidism; patients with vitiligo; asthma that has completely resolved inchildhood and does not require any intervention in adulthood may be included; patientswho require medical intervention with bronchodilators (asthma, on the other hand,cannot be included).
• Patients who are on immunosuppressive, or systemic hormone therapy forimmunosuppressive purposes (doses >10 mg/day prednisone or other equipotent hormone)and are continuing to use them within 2 weeks prior to enrollment.
• Patients who have received hematopoietic stimulating factors, such as granulocytecolony-stimulating factor (G-CSF), erythropoietin, etc., within 1 week prior to thefirst administration of the study drug.
• Positive test results for HIV antibodies or syphilis spirochete antibodies. Patientswith active hepatitis B or C:
• If HBsAg or HBcAb is positive, add HBV DNA test (the result is higher than the upperlimit of the normal range).
• Additional HCV RNA testing if positive for HCV antibodies (results above the upperlimit of the normal range).
• Persons with known hypersensitivity to recombinant humanized PD-1 monoclonal antibodydrugs and their components.
• Massive pleural or ascites fluid with clinical symptoms and requiring symptomaticmanagement.
• Active lung disease (interstitial pneumonia, pneumonia, obstructive lung disease,asthma) or a history of active tuberculosis.
• Have any clinical problems beyond their control, including but not limited to:Persistent or active (severe) infection;
• Poorly controlled diabetes;
• Cardiac disease (Class III/IV congestive heart failure or heart block as defined bythe New York Heart Association);
• Have or suspect autoimmune disease, or a history of autoimmune disease or syndromerequiring steroid/immunosuppressive systemic therapy, such as: hypopituitaritis,colitis, hepatitis, nephritis, hyperthyroidism, hypothyroidism, etc;
• Deep vein thrombosis or pulmonary embolism; myocardial infarction; severe or unstablearrhythmia or angina; percutaneous coronary intervention, acute coronary syndrome,coronary artery bypass grafting; cerebrovascular accident, transient ischemic attack,cerebral embolism within 6 months prior to first dose.
• Abnormal coagulation (INR > 2.0, PT > 16s), with bleeding tendency or on thrombolyticor anticoagulant therapy, allowing prophylactic use of low-dose aspirin, low-molecularheparin.
• Those who had clinically significant bleeding symptoms or clear bleeding tendencywithin 3 months prior to randomization, such as daily cough/hemoptysis of 2.5 ml ormore, gastrointestinal bleeding, esophagogastric fundic varices at risk of bleeding,bleeding gastric ulcers or suffering from vasculitis, etc., may be reviewed if thefecal occult blood is positive at baseline, and if it is still positive after review,gastroscopy is required, and if gastroscopy indicates severe esophagogastric fundicvarices cannot be enrolled (except for those who underwent gastroscopy 3 months orless before enrollment to exclude such conditions).
• Known presence of hereditary or acquired bleeding and thrombotic tendencies (e.g.,hemophiliacs, coagulation disorders, thrombocytopenia, etc.)
• Have received a stem cell transplant or organ transplant.
• Those with a history of psychotropic substance abuse and unable to abstain or ahistory of mental disorders.
• Other serious, acute or chronic medical conditions or laboratory test abnormalitiesthat, in the judgment of the investigator, may increase the risk associated withparticipation in the study, or may interfere with the interpretation of study results.
• The patient had a history of other malignancies within five years.