Advanced Solid Tumor
Conditions
Keywords
liquid tumor-infiltrating lymphocytes, anti-PD-1, resistance, solid tumor
Brief summary
Safety and effectiveness of liquid tumor infiltrating lymphocytes in patients with advanced malignant tumors who have failed to anti-PD-1 therapy
Interventions
BIOLOGICALliquid tumor infiltrating lymphocytes
Isolatation and amplification PD-1+ cells from peripheral blood lymphocytes under GMP conditions for clinical use.
Sponsors
Henan Cancer Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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 * 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the rate of reverse events | three months | the rate of reverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| clinical benefit rate | three months | the proportion of patients benefit from liquid tumor infiltrating lymphocytes |
| time to progression | six months | from the date of therapy to the first date of determined progressive disease |
Countries
China
Contacts
Primary ContactQuanli Gao, Dr.
Backup ContactTiepeng Li, Dr.
Outcome results
None listed