Solid tumor
Conditions
Interventions
experimental group:autologous PTA chimeric antigen receptor T cells
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to be enrolled in this study: 1. At the time of signing the informed consent, the age>= 18 years old and 40 kg; 3. Patients with HCC and colorectal cancer confirmed by pathology; 4. Patients with relapsed or refractory diseases (in stage III or IV) who fail or relapse after at least two lines of treatment; 5. There is at least one measurable focus in patients according to the RECIST 1.1 standard, that is, according to the CT or MRI cross-sectional image, the length of non lymph node focus >= 10 mm, or the length of lymph node focus >= 15 mm; the longest axis of measurable focus CT scan >= 10 mm (CT scan layer thickness = 1.5 x 10 ^ 9 / L, platelet count >= 75 x 10 ^ 9 / L, HGB > 90g / L (no blood transfusion within two weeks), ALC >= 0.8 x 10 ^ 9 / L; 7. Patients with sufficient liver and kidney functions: AST and alt = 40 ml / min; 8. Pt or INR = 25%). There were three cases: (1) The tumor tissue samples with recurrence or presence of primary site within one year were detected as tm4sf1 positive by immunohistochemistry; (2) Tm4sf1 positive was detected by immunohistochemistry after biopsy in non primary tumor metastasis; (3) The tumor tissue samples remained in the primary focus for more than one year, which were confirmed to be tm4sf1 positive by re biopsy immunohistochemistry. 10. Pregnant women of childbearing age (15-49 years old) must undergo pregnancy test within 7 days before treatment and the result is negative. 11. Patients with ECoG score <= 2; 12. Patients with an estimated survival of not less than 12 weeks.
Exclusion criteria
Exclusion criteria: Patients meeting any of the following exclusion criteria were excluded from the group: 1. Patients who have received any anti-tumor radiotherapy and chemotherapy treatment within 4 weeks before blood collection alone; 2. Patients who received anti-pd1 and anti-PD-L1 treatment within 12 weeks before blood sampling alone; 3. Patients with organ transplantation history; 4. Pregnant or lactating patients; 5. Patients with uncontrolled infectious diseases, such as baseline HBV DNA >= 2000 IU / ml, anti HIV positive, HCV RNA positive; 6. Other patients with active infection with significant clinical significance; 7. In the past 5 years, patients with other active malignant tumors, such as basal or squamous skin cancer, superficial bladder cancer, breast cancer in situ, have been completely cured, and subjects who do not need follow-up treatment are not included; 8. Patients with severe autoimmune diseases such as ulcerative colitis, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, autoimmune vasculitis or Wegener's granulomatosis need long-term (more than 2 months) systemic immunosuppressive therapy; 9. Patients with allergic constitution, allergy to immunotherapy or related drugs; 10. Patients with organ failure, heart: Level III and level IV; or patients with hypertension that cannot be controlled by standard treatment, with previous history of myocarditis or myocardial infarction within one year; liver: reaching level C of child Turcotte liver function grade; kidney: renal failure and uremia; lung: severe respiratory failure; brain: people with consciousness disorder; 11. Patients with active bleeding and thrombotic diseases requiring treatment; 12. Patients with uncontrollable pleural or peritoneal effusion who need clinical treatment or intervention; 13. Patients with T-cell tumors, such as T-cell lymphoma, etc; 14. Subjects under treatment with systemic steroids or steroid inhalers; 15. Patients with any mental illness, including dementia and mental state change, may affect informed consent and related questionnaire understanding subjects; 16. Patients who have participated in other clinical trials in the past 30 days; 17. Patients with serious uncontrollable diseases determined by the researchers, or other conditions, may affect the treatment of this study, and they are not suitable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival;AE;DFS/PFS;PK (Tmax, Cmax, T1/2, AUC0-28d);PD (Tmax, Cmax, ET1/2, AUC0-28d of serum cytokines); | — |
Countries
China
Contacts
Public ContactZhang yi
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed