Advanced primary liver cancer
Conditions
Interventions
Experimental group:Sequential therapy with targeted activation of CIK cells and PD-1 mab
Sponsors
Beijing GoBroad Boren Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age from 18 to 75, regardless of gender; 2. Patients with primary liver cancer or metastatic liver cancer who are clinically confirmed or confirmed by tissue/cytology according to the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (Ministry of Health, 2019 edition), and whose pathologic examination shows that any target of MUC1/GPC3/EGFR is positive; 3. Have at least one measurable lesion; (1) Measurable lesions were defined as non-lymphoid lesions with the longest single diameter >=10mm or lymph node lesions with the shortest diameter >=15mm; (2) The lesion after previous interventional, radiotherapy or ablation treatment can also be used as a measurable target if it has progressed according to RECIST1.1 criteria and the longest diameter is >=10mm; 4. BCLC stage B-C; 5. Patients with advanced primary liver cancer who cannot tolerate systemic therapy (systemic chemotherapy and/or molecular targeted therapy) and local therapy, or >=2 times of local therapy and progression of disease after systemic therapy; 6. Child-pugh liver function score =6 months; 10. No antitumor drugs were used within 4 weeks before the first medication; 11. ECOG score =28g/L, serum ALT and AST<=5.0*ULN, serum TBIL<=2*ULN, electrolyte normal or normal after treatment, serum creatinine <=1.5*ULN; 14. Blood routine examination standards should meet: HB=90g/L; The ANC acuity 1.5*10^9/L; PLT 50*10^9/L or higher; 15. No other serious diseases that conflict with the programme (e.g. autoimmune diseases, immunodeficiency, organ transplantation); 16. Subjects voluntarily signed written informed consent and were able to comply with the requirements of the program for visiting.
Exclusion criteria
Exclusion criteria: 1. Severe cirrhosis with moderate or above ascites. B-ultrasound grading criteria for ascites: (1) Small amount of ascites: ascites appear in the space between liver and kidney, pelvic cavity and the right anterior and upper space of liver; (2) Moderate ascites: in addition to the above parts, anechoic areas can be found in gallbladder bed, peribladder, omental sac and perispleen; (3) Large amount of ascites: anechoic zone can be seen around liver and spleen, pelvic cavity and intestinal loops, and mesentery and intestinal tube can be seen floating in anechoic zone; 2. Complete carcinoma thrombus in main and left and right branches of portal vein, obstructive jaundice, liver failure, hepatic encephalopathy; 3. Patients with t-cell lymphoma, myeloma, or those on immunosuppressants; 4. Patients with systemic autoimmune diseases, allergies or immune deficiency; 5. Patients with chronic diseases requiring immunizations or long-term hormone therapy; 6. Have active bleeding or abnormal coagulation function (PT>16s, APTT>43s, TT>21s, INR>=2), have bleeding tendency or are receiving thrombolytic, anticoagulant or antiplatelet therapy; 7. Pregnant or lactating female patients, or those who do not want to use contraception during the trial; 8. Any significant clinical and laboratory abnormality that the investigator considers to influence the safety evaluator, such as: Uncontrolled active infection (>NCI-CTC AE V4.0 level 2), uncontrolled diabetes (>NCI-CTC AE V4.0 level 2), hypertension that cannot be reduced to the following range by two or more antihypertensive drugs (systolic blood pressure NCI-CTC-AE V4.0 standard grade 2), etc. 9. Patients with any previous history of cerebral or subdural metastases or mental disorders; Head CT/MRI should be performed in patients with neurological symptoms to exclude cerebral or subdural metastases; 10. Have a history of gastrointestinal bleeding within the past 6 months or have a clear tendency of gastrointestinal bleeding, such as known local active ulcer lesions, fecal occult blood ++ or above cannot be included in the group; If fecal occult blood +, gastroscopy is required; 11. Patients with severe gastric/esophageal varices requiring interventional therapy; 12. Abdominal fistula, gastrointestinal perforation, or abdominal abscess within 4 weeks prior to initial treatment; 13. Abnormal glomerular filtration rate (endogenous creatinine clearance rate 1.5*ULN); 14. Known anti-HCV antibody, TPHA, anti-HIV positive; 15. Those who are allergic to both CT and MRI contrast media and cannot be evaluated by imaging; 16. Received any experimental drug or medical device within 4 weeks prior to initial treatment; Patients that other researchers considered unsuitable for cell therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total survival time; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival time;Time to tumor progression;Objective response rate;Disease control rate; | — |
Countries
China
Contacts
Public ContactFan Li
Beijing GoBroad Boren Hospital
Outcome results
None listed