Digestive tract cancer
Conditions
Interventions
experimental group:adjuvant therapy with NK cells
control group:No adjuvant therapy with NK and other immune cells
Sponsors
the Affiliated Hospital of Qingdao University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age =18 years and =75 years, gender is not limited; (2) Patients with early-stage GI cancer diagnosed as feasible for radical surgical resection. The determination of early-stage cancer will follow the clinical diagnosis and treatment guidelines or expert consensus of the corresponding cancer types, and also combine with the comprehensive judgment of the principal investigator on the patient's situation; (3) At the time of screening, routine blood tests should meet the following criteria: white blood cells =3×10^9/L; neutrophils =1.5×10^9/L; platelets =75×10^9/L; hemoglobin =90 g/L; liver function tests should meet the following criteria: serum bilirubin =1.5×upper limit of normal; and coagulation function tests should meet the following criteria: International Normalized Ratio (ISR) <1.3 (without anticoagulation). 1.3 (without anticoagulant); international normalized ratio < 3 (with anticoagulant); (4) ECOG-PS score of 0-1; (5) Patients with other conditions that could benefit from enrollment in treatment as assessed by the principal investigator; (6) Voluntarily signing the informed consent form, following the requirements of the study protocol and being able to complete all trial procedures, good compliance, and cooperating with follow-up visits.
Exclusion criteria
Exclusion criteria: Any one of the following conditions can be excluded from enrollment: (1) Previous treatment with immune cell therapy, including Lymphokine Activated Killer cells (LAK), NK, Dendritic Cells (DC), Cytokine-induced Killer (CIK), Cytotoxic T Lymphocytes (CTL) or other types of immune cell therapy. , Cytotoxic T Lymphocytes (CTL) or other types of immune cell therapy; (2) Known to have an allergic reaction to any of the ingredients used in this study treatment; (3) Medically uncontrolled hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >90 mmHg) or clinically significant (e.g., active) cardiovascular disease, such as cerebrovascular accident (within 6 months prior to signing of the Master Informed Consent Form), myocardial infarction (within 6 months prior to signing of the Master Informed Consent Form), unstable angina pectoris, congestive heart failure with a New York Heart Association classification of Class II or higher, or severe cardiac failure. heart failure, or severe arrhythmia that cannot be controlled medically or has potential impact on study treatment; ECG showing clinically significant abnormalities or mean QTcF =450ms (=480ms in women) on 3 consecutive results (each at least 5 minutes apart); (4) At screening, patients with creatinine clearance (CCr) grade 1 (NCI-CTCAE 5.0), except alopecia; (8) Subjects who are on immunosuppressive, or systemic, or absorbable topical hormone therapy for immunosuppression (dose >10 mg/day prednisone or other equipotent hormone) and continue to use it within 4 weeks prior to enrollment; (9) Patients who have received targeted therapy, surgery within 4 weeks prior to dosing; those who are expected to require surgery during the trial (planned elective surgery); (10) Patients who have received radiation/chemotherapy within 4 weeks prior to dosing; (11) Evidence of CNS metastasis at baseline; (12) A definite prior history of severe neurologic or psychiatric disorders, including epilepsy or dementia; (13) Have T-cell or NK-cell lymphoma; (14) Have an active systemic infection requiring treatment, including, but not limited to, active tuberculosis, and known HIV-positive, syphilis spirochete-positive subjects or patients with clinically active hepatitis A, B, or C, including carriers of the virus, should be excluded; (15) Those who have a birth plan or do not agree to use a reliable contraceptive method for contraception during the trial period and for 3 months after the last dose; (16) Enrollment in other clinical trials within 4 weeks prior to dosing; (17) Women who are pregnant or breastfeeding; (18) Persons who, in the opinion of the investigator, are not suitable for participation in this clinical study for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Analysis of immune cell subpopulation;Overall Survival,OS;Disease Free Survival,DFS; | — |
Countries
China
Contacts
Public ContactRen He
the Affiliated Hospital of Qingdao University
Outcome results
None listed