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

Guangzhou University of Traditional Chinese Medicine

Status: Unknown

Conditions: Lymphoepithelioma-Like Carcinoma

Treatments: Drug: PD-1 monoclonal antibody

Study type: Interventional

Funder types: Other

Identifiers

NCT04430166

2019KT1192

Details and patient eligibility

About

Lymphoepithelioma-like carcinoma (LELC) may benefit from immunocheckpoint inhibitor therapy. Although target antibody drugs for PD-1 and PD-L1 have achieved good results in immunotherapy of many malignant tumors, there is still a lack of corresponding clinical research reports on whether LELC treatment can benefit. Therefore, this study intends to adopt the basket research model , to explore the application of anti-procedural death receptor 1 (PD-1) monoclonal antibody in patients with advanced LELC after the failure of first-line standard treatment . Further explore the relationship between tumor and body immunity, tumor microenvironment and curative effect, and find stable biomarkers, so as to screen out the superior population of tumor immunotherapy.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

PD-1 monoclonal antibody

Experimental group

Treatment:

Drug: PD-1 monoclonal antibody