PD-1 Monoclonal Antibody in Pre-treated Lymphoepithelioma-like Carcinoma

This is an interventional treatment trial for Lymphoepithelioma-Like Carcinoma focused on measuring Lymphoepithelioma-like carcinoma, PD-1 monoclonal antibody Read More

Inclusion Criteria:

• Histological or cytological diagnosis of lymphoepithelioma-like carcinoma
• Failed the first-line standard treatment or progressed after the treatment, at least one measurable lesion according to the RECIST1.1 standard
• Age between 18 and 80 years old
• Estimated life expectancy exceeds 3 months
• ECOG Performance Status score ≤ 2
• Normal bone marrow, liver, kidney, clotting function, including： hemoglobin ≥90g/L (no history of blood transfusion within 7 days), absolute neutrophil count ≥1.5×109/L, platelet ≥100×109/L, total bilirubin ≤1.5×ULN, albumin ≥30g/ L, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN), if combined with liver metastases, AST and ALT ≤ 5 × ULN; creatinine ≤ 1.5 × ULN; international standardized ratio (INR) or coagulation Proenzyme time (PT) ≤ 1.5 × ULN, if the subject receives anticoagulant therapy normally, as long as the PT is within the range planned by the anticoagulant drug
• Women of childbearing age should have a urine or serum pregnancy test negative within 3 days before receiving the first study drug administration. If the urine pregnancy test result cannot be confirmed negative, a blood pregnancy test is required
• Ensure effective contraception during the study period and at least 6 months after the study ended.
• Sign an informed consent form and follow up with good compliance

Exclusion Criteria:

• Merging other pathological tumors
• Active bleeding, active diverticulitis, abdominal abscess, gastrointestinal perforation, gastrointestinal obstruction, and peritoneal metastasis that require clinical intervention; clinically uncontrollable pleural, abdominal, and pericardial effusions (drainage effusions are not required or patients who have stopped draining for 3 days without a significant increase in effusion can be enrolled); severe bleeding tendency or coagulopathy；receiving thrombolytic therap
• Uncontrolled hypertension（systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg after optimal medical treatment）；history of hypertension crisis or hypertensive encephalopathy
• History of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation)
• Grade III-IV congestive heart failure (according to New York Heart Association classification), poorly controlled and clinically significant
• Any arterial, venous thrombosis, embolism, or ischemia occurred within 6 months before enrolling in the treatment
• Central nervous system metastasis
• Active infection that requires treatment, or systemic anti-infective drugs have been used within one week before the first dose; or there is active tuberculosis (TB), normal anti-TB treatment or anti-TB within 1 year before the first dose treatment
• Known history of human immunodeficiency virus (HIV) infection (ie HIV1/2 antibody positive), known syphilis infection
• Acute or chronic active hepatitis B or hepatitis C infection, including hepatitis B virus (HBV) DNA>2000IU/ml or 104 copies/ml，hepatitis C virus (HCV) RNA>103 copies/ml or HBsAg Positive simultaneously with anti-HCV antibody
• Active autoimmune diseases requiring systemic treatment occurred within 2 years before the first dose(alternative therapies such as thyroxine, insulin, or physiological doses of corticosteroids used for adrenal or pituitary insufficiency are not considered systemic treatment）
• History of non-infectious pneumonia requiring corticosteroid therapy or current pneumonia within 1 year before the first dose（patients with intermittent use of bronchodilators, inhaled corticosteroids, or local injection of corticosteroids due to COPD and asthma can be enrolled）
• Previously received immunotherapy treatment, or received immunomodulatory drug treatment within 2 weeks before the first dose, or received major surgical treatment within 3 weeks before the first dose
• Known to have an allergic reaction to the active ingredient of PD-1 monoclonal antibody and/or any excipients
• Mental illnesses or drug abuse that may affect compliance with research requirements
• Currently participating in interventional clinical research treatment, or receiving other research drugs or research equipment within 4 weeks before the first dose
• Women who are pregnant or breastfeeding
• Other acute, chronic and mental diseases that may lead to the following results: laboratory test values are abnormal；increase the risk of research participation or study drug administration； interfere with the interpretation of the study results