Advanced Solid TumorNCT04268108
L-TIL in Patients With Malignancy Resistance to Anti-PD-1 Therapy
An observational study of Advanced Solid Tumor, run by Henan Cancer Hospital at 1 site in China.
Trial summary
Safety and effectiveness of liquid tumor infiltrating lymphocytes in patients with advanced malignant tumors who have failed to anti-PD-1 therapy Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- liquid tumor infiltrating lymphocytes
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 2 Apr 2020to 19 Jun 2022
- Phase
- Observational
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible patients in our hospital
Who may be able to join
- Expected lifespan is over 3 months
- malignant tumors diagnosed by pathological examination
- Imaging examination is at advanced stage with at least one measurable lesion
- Ineffective or resistant to previous anti-PD-1 therapy
- ECOG score 0-2
- Adequate organ function
Show all 9Show fewer
- No other serious diseases that conflict with this protocol
- Women of childbearing age must check for a negative blood pregnancy test within 7 days, and subjects of childbearing age must use appropriate contraception during the test and within 3 months
- witten informed consent from the patients
Who cannot join
- Severe infectious disease within 4 weeks before enrollment
- Active hepatitis B or C virus or HIV infection
- Severe autoimmune disease or immunodeficiency disease
- Severe allergies
- Severe mental disorder
- Systematically used a large amount of glucocorticoids within 4 weeks before enrollment
- With severe heart, liver, kidney insufficiency, diabetes and other diseases
- Participation in other clinical studies in the past 3 months or having been treated with other gene products
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Zhengzhou, Henan, 450008
Quanli Gao, M.D, +86-371-65587795, gaoquanli2015@126.com
Lingdi Zhao, M.D., +86-371-65587483, lingdizhao@126.com
About this study
Official title: Clinical Study of Liquid Tumor Infiltrating Lymphocytes in Patients With Advanced Malignancies Resistance to Anti-PD-1 Therapy
Safety and effectiveness of liquid tumor infiltrating lymphocytes in patients with advanced malignant tumors who have failed to anti-PD-1 therapy
- Conditions
- Advanced Solid Tumor
- Being tested
- liquid tumor infiltrating lymphocytes
- Keywords
- liquid tumor-infiltrating lymphocytes, anti-PD-1, resistance, solid tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liquid tumor infiltrating lymphocytesBiological
Isolatation and amplification PD-1+ cells from peripheral blood lymphocytes under GMP conditions for clinical use.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | arm 1: secondary resistance to anti-PD-1 therapy: this patients group received liquid tumor infiltrating lymphocytes combined anti-PD-1 therapy.
arm 2: primary resistance to anti-PD-1 therapy: this patients group received FC preconditioning before received liquid tumor infiltrating lymphocytes Receives: Biological: liquid tumor infiltrating lymphocytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of reverse events
the rate of reverse events
Measured: three months
Secondary outcomes (2)
clinical benefit rate
the proportion of patients benefit from liquid tumor infiltrating lymphocytes
Measured: three months
time to progression
from the date of therapy to the first date of determined progressive disease
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start2 Apr 2020
- Primary completion19 Feb 2022 (estimated)
- Study completion19 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04268108
- Sponsor's protocol ID
- Liquid TIL
- Status last verified
- Feb 2020
- First submitted
- 11 Feb 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Need to solicit patients' consent whether to agree to share their information during the enrollment process,
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Liquid Tumor Infiltrating Lymphocytes in Patients With Advanced Malignancies Resistance to Anti-PD-1 Therapy
- ClinicalTrials.gov ID
- NCT04268108
- Acronym / sponsor ID
- Liquid TIL
- Conditions
- Advanced Solid Tumor
- Keywords
- liquid tumor-infiltrating lymphocytes, anti-PD-1, resistance, solid tumor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 2 Apr 2020 (actual)
- Primary completion
- 19 Feb 2022 (estimated)
- Study completion
- 19 Jun 2022 (estimated)
- First posted
- 13 Feb 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.
Safety and effectiveness of liquid tumor infiltrating lymphocytes in patients with advanced malignant tumors who have failed to anti-PD-1 therapy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | Biological: liquid tumor infiltrating lymphocytesarm 1: secondary resistance to anti-PD-1 therapy: this patients group received liquid tumor infiltrating lymphocytes combined anti-PD-1 therapy. arm 2: primary resistance to anti-PD-1 therapy: this patients group received FC preconditioning before received liquid tumor infiltrating lymphocytes |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients in our hospital
Key inclusion criteria (9 listed)
- Expected lifespan is over 3 months
- malignant tumors diagnosed by pathological examination
- Imaging examination is at advanced stage with at least one measurable lesion
- Ineffective or resistant to previous anti-PD-1 therapy
- ECOG score 0-2
Key exclusion criteria (8 listed)
- Severe infectious disease within 4 weeks before enrollment
- Active hepatitis B or C virus or HIV infection
- Severe autoimmune disease or immunodeficiency disease
- Severe allergies
- Severe mental disorder
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 |
|---|---|---|
| liquid tumor infiltrating lymphocytesIsolatation and amplification PD-1+ cells from peripheral blood lymphocytes under GMP conditions for clinical use. | Biological | group 1 |
Primary outcome
the rate of reverse events
Time frame: three months
the rate of reverse events
2 secondary outcomes
clinical benefit rate
Time frame: three months
time to progression
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Individual participant dataSharing planned: Undecided. Need to solicit patients' consent whether to agree to share their information during the enrollment process,
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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?
An observational study of Advanced Solid Tumor, run by Henan Cancer Hospital 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 8 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 11 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 Quanli Gao, Dr. (+86-371-65587795, gaoquanli2015@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of reverse events (time frame: three months). 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 11 Jun 2020.