Intermediate and advanced malignant solid tumors (including colorectal cancer, lung cancer, esophageal cancer, stomach cancer, liver cancer, kidney cancer and malignant melanoma)
Conditions
Interventions
Group 1:PD-1 inhibitor by Intravenous infusion
Group 2:Intravenous infusion of PD-1 inhibitor (200mg) and UCBNK cells (5×10E6- 5×10E7/kg) the next day
Sponsors
The Second Affiliated Hospital of Xi'an Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients with clinicopathologically confirmed advanced malignant solid tumors (including colorectal cancer, lung cancer, esophageal cancer, stomach cancer, liver cancer, kidney cancer and malignant melanoma, etc.) were assessed by the surgical MDT group to lose the chance of surgical resection, and the patients were fully aware of the general standard treatment regimen for relevant tumors, and the patients were enrolled voluntarily; 2. Aged 18 to 80 years; 3. Cardiopulmonary liver and kidney function and bone marrow reserve function are normal, and can tolerate ultrasound puncture treatment under anesthesia. The results of laboratory tests should meet at least the following requirements: Good heart function: Echocardiogram shows ejection fraction greater than 45%; Good lung function: lung carbon monoxide diffusion (DLCO) or maximum expiratory volume (FEV1) is greater than expected 45%; Good liver function: aspartate aminotransferase (AST / SGOT) =25g/L; 4. Karnofsky score>=70; 5. No comorbid infection; 6. No obvious biliary and digestive tract obstructions; 7. Patients who have not been treated with immunosuppressants or glucocorticoids; 8. Life expectancy >=3 months; 9. Not receiving any anti-tumor treatment in the past 4 weeks; 10. Relevant testing, evaluation and management can be conducted regularly in the research institutes in the group during the whole test period; Signing of informed consent: Patients and immediate family members must understand, understand, and voluntarily participate in this study; Measurable lesions: At least one liver metastasis lesion can be measured accurately and continuously.
Exclusion criteria
Exclusion criteria: 1. Participants also had other diseases sufficient to hinder the study, such as poorly controlled hypertension (systolic blood pressure> 160mmHg and / or diastolic blood pressure> 90mmHg) or clinically significant (such as active cardiovascular and cerebrovascular diseases such as Cerebrovascular accident (within 6 months before signing informed consent), myocardial infarction (within 6 months before signing informed consent), unstable angina pectoris, congestive heart failure classified by the New York Heart Association grade II or higher, Or severe arrhythmia cannot be controlled with drugs or has a potential impact on research treatment; uncontrolled lung disease, mental illness, social behavior abnormalities, etc.; 2. Active infection, such as known HIV positive patients or patients with hepatitis A and C and syphilis; 3. Patients with autoimmune disease or history of organ transplantation; those who are using hormones, immunosuppressants or antiviral drugs; 4. Patients who have undergone radioactive, radiotherapy, chemotherapy, surgery, or ultrasound implantation of radioactive particles in the past 4 weeks, or those who have not recovered from the above-mentioned surgery or treatment-related adverse reactions to mild abnormalities or normal; 5. For pregnant or lactating women, women of gestational age need to use effective contraceptive methods with the consent of their partners, before and during the study, and within 6 months after the study is completed. The women participating in the test should inform the doctor in charge if they suspect that pregnancy is possible during the study; 6. Distant tumor metastases, such as bone metastases, brain metastases, or the presence of ascites once and above (once defined as: the navel is the standard and the navel is lower than the line connecting the two metatarsals) 7. Patient has other malignant tumors combined with two types of primary solid tumors; 8. The patient, the blood donor's immediate family member or any of the patient's representatives refuses to sign the informed consent; 9.patients are participating in other clinical trials; 10.Patients' rule-breaking: The research doctors think that other reasons are not suitable for the clinical trial, such as the patient's failure to comply with the safety monitoring rules required by this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective remission rate (CR, PR, SD, PD); | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate (DCR);overall response rate;clinical benefit rate (CBR);life quality evaluation;overall survival;Peripheral blood related immune indicators;VAS; | — |
Countries
China
Contacts
Public ContactGao Jun, Yang Liuqing
The Second Affiliated Hospital of Xi'an Medical University
Outcome results
None listed