Lymphoepithelioma-Like CarcinomaNCT04430166
PD-1 Monoclonal Antibody in Pre-treated Lymphoepithelioma-like Carcinoma
A study testing PD-1 monoclonal antibody in people with Lymphoepithelioma-Like Carcinoma, run by Guangzhou University of Traditional Chinese Medicine at 1 site in China.
Trial 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 malignant tumors, there is still a lack of corresponding clinical research reports on whether LELC treatment can benefit. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lymphoepithelioma-Like Carcinoma
- What is being tested?
- PD-1 monoclonal antibody
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2020to 1 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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 locations and contacts
1 site in 1 country.
China1 site
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, 510120
Lirong Liu, MM, 86 20 81887233 ext. 34830, doctorllr@163.com
Zhenzhen Xiao, MM, 86 20 81887233 ext. 34830, 768197690@qq.com
About this study
Official title: A Exploratory Clinical Study on PD-1 Monoclonal Antibody in Pre-treated Lymphoepithelioma-like Carcinoma
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.
- Conditions
- Lymphoepithelioma-Like Carcinoma
- Being tested
- PD-1 monoclonal antibody
- Keywords
- Lymphoepithelioma-like carcinoma, PD-1 monoclonal antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1 monoclonal antibodyDrug
200mg / intravenous drip, once every three weeks
| Study group | Role | What they receive |
|---|---|---|
| PD-1 monoclonal antibody | Experimental | Not described Receives: Drug: PD-1 monoclonal antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progress-free survival
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.
Measured: Through study completion, an average of 9 weeks
Secondary outcomes (5)
Objective response rate
According to the RECIST 1.1 standard, the proportion of subjects with complete response(CR) or partial response(PR) in the analysis population.
Measured: Through study completion，an average of 9 weeks
Time to initial response
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.
Measured: Through study completion，an average of 9 weeks
Overall survival
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.
Measured: Through study completion， an average of 90 days
Duration of response
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.
Measured: Through study completion，an average of 9 weeks
Tumor immune microenvironment
immune microenvironment state of tumor tissue will be detected by Opal multiplex immunofluorescence assay
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start1 Jun 2020 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoepithelioma-Like CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haibo Zhang, Guangzhou University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04430166
- Sponsor's protocol ID
- 2019KT1192
- Status last verified
- Dec 2019
- First submitted
- 28 May 2020
- Last updated
- 12 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Exploratory Clinical Study on PD-1 Monoclonal Antibody in Pre-treated Lymphoepithelioma-like Carcinoma
- ClinicalTrials.gov ID
- NCT04430166
- Acronym / sponsor ID
- 2019KT1192
- Conditions
- Lymphoepithelioma-Like Carcinoma
- Keywords
- Lymphoepithelioma-like carcinoma, PD-1 monoclonal antibody
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Guangzhou University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 12 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD-1 monoclonal antibody | Experimental | Drug: PD-1 monoclonal antibody |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PD-1 monoclonal antibody200mg / intravenous drip, once every three weeks | Drug | PD-1 monoclonal antibody |
Primary outcome
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.
5 secondary outcomes
Objective response rate
Time frame: Through study completion，an average of 9 weeks
Time to initial response
Time frame: Through study completion，an average of 9 weeks
Overall survival
Time frame: Through study completion， an average of 90 days
Duration of response
Time frame: Through study completion，an average of 9 weeks
Tumor immune microenvironment
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2020.
- Individual participant dataSharing planned: No
Related trials for Lymphoepithelioma-Like Carcinoma
RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma
RecruitingPhase 2
Safety and Efficacy of Pucotenlimab in pLECC
Lymphoepithelioma-like Carcinoma, Lymphoepithelioma
RecruitingObservational study
The Chinese Pulmonary Lymphoepithelioma-like Carcinoma Collaboration Study
Primary Pulmonary Lymphoepithelioma-like Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PD-1 monoclonal antibody in people with Lymphoepithelioma-Like Carcinoma, run by Guangzhou University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lirong Liu, MM (86 20 81887233 ext. 34830, doctorllr@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progress-free survival (time frame: Through study completion, an average of 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2020; AzTrials last refreshed its copy on 8 Nov 2026.