- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04430166
PD-1 Monoclonal Antibody in Pre-treated Lymphoepithelioma-like Carcinoma
A Exploratory Clinical Study on PD-1 Monoclonal Antibody in Pre-treated Lymphoepithelioma-like Carcinoma
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Zhenzhen Xiao, MM
- Phone Number: 34830 86 20 81887233
- Email: 768197690@qq.com
Study Locations
-
-
Guangdong
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Guangzhou, Guangdong, China, 510120
- Guangdong Provincial Hospital of Chinese Medicine
-
Contact:
- Zhenzhen Xiao, MM
- Phone Number: 34830 86 20 81887233
- Email: 768197690@qq.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: PD-1 monoclonal antibody
|
200mg / intravenous drip, once every three weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progress-free survival
Time Frame: Through study completion, an average of 9 weeks
|
The time from enrollment to the occurrence of tumor development (in any aspect) or death (for any reason). For subjects without disease progression or death, the date of the last imaging evaluation is the date of censorship. Subjects who did not undergo imaging evaluation or no death record after baseline were deleted based on the enrollment date. |
Through study completion, an average of 9 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate
Time Frame: Through study completion,an average of 9 weeks
|
According to the RECIST 1.1 standard, the proportion of subjects with complete response(CR) or partial response(PR) in the analysis population.
|
Through study completion,an average of 9 weeks
|
Time to initial response
Time Frame: Through study completion,an average of 9 weeks
|
The time from enrollment to the first objective response (CR or PR) of the tumor. For subjects who did not reach CR or PR, the date of the last imaging evaluation was the date of censorship. |
Through study completion,an average of 9 weeks
|
Overall survival
Time Frame: Through study completion, an average of 90 days
|
The time from enrollment to (for any reason) death.
At the end of the study, if the subject is still alive, the known date of the subject's last survival" will be the censored date.
|
Through study completion, an average of 90 days
|
Duration of response
Time Frame: Through study completion,an average of 9 weeks
|
The time from the first recorded objective tumor response (CR or PR) to objective disease progression (PD) or death. For subjects without disease progression or death, the date of the last imaging evaluation is the date of censorship. |
Through study completion,an average of 9 weeks
|
Tumor immune microenvironment
Time Frame: Baseline
|
immune microenvironment state of tumor tissue will be detected by Opal multiplex immunofluorescence assay
|
Baseline
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019KT1192
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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