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This study is a card Rayleigh bead single combined cisplatin treatment of advanced squamous cell carcinoma of the skin resistance of single arm phase II study, open, single center, plan in two years into the group of 20 cases with histologic diagnosis of lymph node metastasis or distant metastasis CSCC of (1) or surgery can't/couldn't thorough radiotherapy, CSCC of locally advanced (class 2), To evaluate the efficacy of camrelizumab (PD-1 mab) combined with cisplatin in the treatment of advanced CSCC.
Full description
This study is a card Rayleigh bead single combined cisplatin treatment of advanced squamous cell carcinoma of the skin resistance of single arm phase II study, open, single center, plan in two years into the group of 20 cases with histologic diagnosis of lymph node metastasis or distant metastasis CSCC of (1) or surgery can't/couldn't thorough radiotherapy, CSCC of locally advanced (class 2), To evaluate the efficacy, safety and quality of life of patients with advanced CSCC treated with camrelizumab (PD-1 mab) combined with cisplatin.
Enrollment
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Inclusion criteria
Exclusion criteria
intranasal inhaled topical steroid treatment or topical steroid injection (e.g., intra-articular injection); 2) Systemic corticosteroid treatment not exceeding 10 mg/ day of prednisone or its equivalent physiological dose;
Glucocorticoids as prophylaxis for allergic reactions (e.g. pre-CT)
The need for long-term systemic hormone or any other immunosuppressive drug therapy does not include inhaled hormone therapy;
Toxicities due to previous antitumor therapy that did not return to NCI CTCAE V5.0 grade 0 or 1 or the level specified by the enrollment criteria (excluding hair loss, fatigue, or grade 2 or less endocrine related adverse events due to radiation therapy) were present 4 weeks before the first administration of the study drug;
Receive live attenuated vaccine within 4 weeks prior to the first administration of the study drug or planned during the study period;
Had a major surgical procedure (craniotomy, thoracotomy, or laparotomy, or otherwise as defined by the investigator) within 4 weeks prior to the initial administration of the study drug or had an unhealed fracture or was expected to have a major surgery during the duration of the study. Note: Local surgical treatment of isolated lesions is acceptable for palliative care purposes;
No radiographic enhanced radiographic assessment could be performed (either iodine-enhanced CT or gadolinium MRI could be enrolled). If other conditions are met, any contrast-enhanced radiography cannot be accepted, but comprehensive tumor evaluation can be performed by caliper measurement, and the study can be enrolled after communication with the investigator.
Other antitumor therapy (palliative radiotherapy permitted) is anticipated during the trial treatment;
A history of pneumonia requiring hormonal therapy, or interstitial lung disease (including past and present history), with the exception of local interstitial pneumonia due to radiation therapy;
Known central nervous system (CNS) metastases and/or spinal cord compression and/or cancerous meningitis,
History of pIA. Patients with asymptomatic brain metastases (i.e., no neurologic symptoms, no need for glucocorticoid therapy, and no lesions > 1.5 cm) or stable symptoms after treatment of brain metastases were eligible for participation if they met all of the following criteria:
Measurable lesions outside the central nervous system; No mesencephalon, pons, cerebellum, meninges, medulla oblongata or spinal cord metastases; Participants were clinically stable for at least 4 weeks, had no evidence of new or expanded brain metastases, and had stopped corticosteroid and anticonvulsant therapy for at least 14 days prior to study treatment;
Active, known or suspected autoimmune disease (see Annex 1) or a history of the disease within the previous 2 years (vitiligo, psoriasis, alopecia or Grave's disease that has not required systematic treatment in the last 2 years, Hypothyroidism requiring only thyroid hormone replacement therapy and type 1 diabetes requiring only insulin replacement therapy were eligible).
Acute or chronic active hepatitis B [defined as hepatitis B surface antigen (HbsAg) and/or hepatitis B core antibody (HbcAb) positive and hepatitis B virus (HBV) DNA copy number ≥1×103 copies /ml or ≥200 copies /ml IU/ml] or positive for acute or chronic active hepatitis C (HCV) antibody; Subjects with positive HCV antibody but negative RNA test were allowed to enroll
Uncontrolled co-morbidities such as
Severe infection occurring within 4 weeks prior to study treatment initiation, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia; Or patients who received therapeutic oral or intravenous antibiotics within 2 weeks before starting study treatment and who received prophylactic antibiotics (e.g., to prevent urinary tract infection or chronic obstructive pulmonary disease) were enrolled;
HIV-infected persons (HIV antibody positive);
History of myocarditis;
Symptomatic congestive heart failure (New York Heart Association Class II-IV) or symptomatic or poorly controlled arrhythmias;
uncontrolled arterial hypertension (systolic blood pressure ≥160mmHg or diastolic blood pressure ≥100 mmHg) despite standard treatment;
Had any arterial thromboembolic event, including myocardial infarction, unstable angina pectoris, cerebrovascular accident, or transient ischemic attack, in the 6 months prior to enrollment;
require immediate intervention of esophageal or gastric varices (binding or hardening treatment, for example) or according to the researchers' opinions or consulting experts of gastroenterology and hepatology experts think the bleeding risk is higher, evidence of the portal hypertension (including imaging examination showed splenomegaly) or a history of varices bleeding of the subjects in the group of the first 3 months must undergo endoscopic evaluation;
Any life-threatening bleeding event or grade 3 or 4 gastrointestinal/varicose bleeding event requiring blood transfusion, endoscopic or surgical treatment within 3 months prior to study enrollment;
A history of deep vein thrombosis, pulmonary embolism, or any other major thromboembolism in the 3 months prior to enrollment (implantable venous port or catheter origin thrombosis, or superficial venous thrombosis is not considered "severe" thromboembolism);
Portal vein tumor thrombus involves both the main portal vein and the left and right branches, or the main portal vein, superior mesenteric vein and inferior vena cava tumor thrombus;
Uncontrolled metabolic disorders or secondary reactions to other non-malignant organ or systemic diseases or cancers that may lead to higher medical risks and/or uncertainty in survival evaluation;
Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh > 7 or more severe cirrhosis;
Subjects at risk for bowel obstruction or perforation (including but not limited to a history of acute diverticulitis, abdominal abscess, or abdominal cancer) or any of the following: inflammatory bowel disease or extensive bowel resection (partial colectomy or extensive bowel resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea;
Significant malnutrition, such as the need for intravenous nutrient supplementation; Malnutrition was not corrected for more than 4 weeks before the first dose of study treatment.
Tumor invasion of surrounding important organs (such as mediastinal great vessels, superior vena cava, trachea, esophagus, etc.) or risk of esophagotracheal fistula or esophagopleural fistula.
After esophageal or tracheal stent implantation
Abnormal values of other acute or chronic diseases or laboratory tests that could increase the risk associated with study participation or study drug administration or interfere with the interpretation of study results and, at the investigator's discretion, classify the subject as ineligible for study participation;
or neurological, psychiatric/social conditions that affect compliance with study requirements, significantly increase the risk of adverse events, or affect the subject's ability to provide written informed consent.
A known history of primary immunodeficiency;
Known active tuberculosis or active syphilis;
Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
Patients who had a history of gastrointestinal perforation and/or fistula within 6 months prior to study enrollment and were not cured by surgery;
Accompanied by uncontrolled third space effusion requiring repeated drainage, such as pleural effusion, ascites, pericardial effusion, etc. (patients who do not need drainage effusion or have no significant increase in effusion within 3 days after stopping drainage can be enrolled);
Patients who had developed other malignancies in the 5 years prior to enrollment, except for cured cervical carcinoma in situ/cutaneous basal cell carcinoma/breast ductal carcinoma in situ and radical prostate cancer with no detectable prostate-specific antigen (PSA) for at least 3 years;
The subject is known to have had a previous severe allergic reaction to other monoclonal antibodies or to any of the study drug preparation components; Pregnant or lactating female subjects.
26.Patients with comorbidities that, in the judgment of the investigator, seriously endanger the safety of the patients or interfere with the completion of the study.
Primary purpose
Allocation
Interventional model
Masking
20 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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