Status:
UNKNOWN
PD-1 Monoclonal Antibody in Pre-treated Lymphoepithelioma-like Carcinoma
Lead Sponsor:
Guangzhou University of Traditional Chinese Medicine
Conditions:
Lymphoepithelioma-Like Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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 malig...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04430166
Start Date
June 1 2020
End Date
October 1 2022
Last Update
June 12 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, China, 510120