| Eligibility |
Inclusion Criteria:
1. Adult female patients (=18 years old);
2. The patient himself voluntarily signed the "informed consent form";
3. HPV positive advanced cervical cancer (refer to FIGO standard);
4. Patients with persistent metastasis or recurrence of squamous cell or non-squamous
cell need to be confirmed by histology or cytology;
5. Patients who have received surgical treatment or other standard first-line treatment
or patients who cannot receive surgical treatment/chemotherapy/radiotherapy;
6. ECOG=2
7. Physical condition is good: KPS=70;
8. The estimated survival time is =3 months;
9. Have not received any treatment that may affect the evaluation of curative effect in
the past 3 months;
10. The functions of liver, kidney and bone marrow are basically normal: HCT > 25%, white
blood cell range 3.5-9.5×109/L, hemoglobin (Hb)=90g, lymphocyte+monocyte > 20%; Blood
Cr=1.5×UNL (the upper limit of normal) and blood BIL = 1.5× UNL; ALT and AST=1.5×UNL
(for patients with liver metastasis, ALT and ast = 5.0× UNL);
11. Women of childbearing age (15-49 years old) must have a pregnancy study within 7 days
before starting treatment and the results are negative; Fertile patients must agree to
use effective contraceptive measures to ensure that they are not pregnant during the
study period and within 3 months after stopping treatment.
Exclusion Criteria:
1. Patients with central nervous system (CNS) metastasis or active CNS injury (i.e.,
imaging instability and symptomatic injury) (except patients with a single metastatic
focus who are stable after treatment);
2. Within 4 weeks before the start of cell infusion, those who have received other
anti-tumor treatments, taken corticosteroids (or analogues) or used systemic
treatments that affect the immune system;
3. Blood pregnancy test positive or lactating female patients;
4. Uncontrolled accompanying diseases and active infectious diseases;
5. Patients who need anticoagulant therapy (warfarin or heparin);
6. The patient was allergic to naproxen, ibuprofen, trimetazidine/sulfamethoxazole and
ampicillin.
7. Have a history of bone marrow transplantation or organ transplantation.
8. Patients who have previously used gene therapy drugs;
9. Patients with the following previous diseases or accompanying diseases:a) Patients who
have been diagnosed as serious autoimmune diseases need systemic immunosuppressants
(steroids) for a long time (more than 2 months) or immune-mediated symptomatic
diseases, including ulcerative colitis, Crohn's disease, rheumatoid arthritis,
systemic lupus erythematosus (SLE) and autoimmune vasculitis (for example, Wegener's
granulomatosis;b) Patients previously diagnosed with motor neuron disease caused by
autoimmune disease; c) Patients with toxic epidermal necrolysis (TEN) in the past; d)
Patients suffering from any mental illness, including dementia and mental state
changes, which may affect informed consent and the understanding and performance of
relevant questionnaires;e) It is determined that patients with serious uncontrollable
diseases may be affected by this study; f) Patients with active malignant tumors such
as basal or squamous skin cancer, superficial bladder cancer and breast cancer in situ
in the past 5 years who have been completely cured and do not need follow-up treatment
are not included;
10. Patients who have used immunotherapy for cancer in the past 6 months include: CIK, DC,
DC-CIK, LAK and other lymphocyte-based immunotherapy patients;
11. Active/chronic human immunodeficiency virus (HIV), syphilis serological positive,
active hepatitis B (hepatitis B surface antigen (HBsAg) positive and hepatitis B virus
(HBV) deoxyribonucleic acid (DNA) > 500IU/ml or the lower detection limit of the
research center [only when the lower detection limit of the research center is higher
than 500 iu/ml]), or hepatitis C virus antibody positive;
12. Have a clear history of drug allergy or an allergic constitution; Patients
participating in other clinical trials at the same time Other circumstances in which
the researcher thinks that the patient should not participate in this experimental
study.
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