Phase
Condition
Abdominal Cancer
Biliary Tract Cancer
Digestive System Neoplasms
Treatment
Allogeneic NK(CCT-ANK-11)
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- The patient agrees to complete the entire treatment plan and sign the informed consentform.
- Age 18 to 65, male or female.
- Malignancy confirmed by histology or imaging diagnosis (computer tomography (CT),magnetic resonance imaging (MRI), contrast-enhanced ultrasound, EOB-MRI), themalignant solid tumor was completely resected (R0).
- Patients who have received surgical treatment 4-8 weeks before the screening period.
- Quality of life assessment form (ECOG) score 0,2.
- Child-Pugh score of liver function ≤ 7.
- The life expectancey is more than 6 months.
- Patients with appropriate hematological functions:
(1)White blood cell (WBC) ≥ 3000 cells / mm3. (2)Absolute neutrophil count (ANC) ≥ 1500cells.
(3)Platelet count (Platelets) ≥ 80000/mm3. (4)Hemoglobin (Hb) ≥ 9g/dl. 9. Patients withappropriate liver and kidney functions:
(1)Urea nitrogen (BUN) ≤ 1.5 times of the upper limit of normal value (ULN).(2)Serumcreatinine (serumcreatinine) ≤ 1.5 times of the upper limit of normal value (ULN).(3)Totalbilirubin (TB) ≤ 1.5 times of the upper limit of normal value (ULN).(4)Glutamic pyruvictransaminase (ALT or GPT) and glutamic oxaloacetic transaminase (AST or GOT) ≤ 2.5 timesthe upper limit of normal value (ULN). 10. Patients who have tested negative for syphilis and AIDS. 11.Patient with activehepatitis B, can take antiviral drugs during the trial period. twelve。 Fertile men and women must use effective contraception within 14 days after signingthe informed consent form and within 14 days after the last dose of natural killer cellsare infused. 13. At least two forms of birth control must be used, one of which must be a barriermethod. Acceptable contraceptive measures include:
(1)Establish oral, injection or implanted hormone contraceptive methods.(2)Placement ofintrauterine device (IUD) or intrauterine system (IUS).(4)Barrier method: condom orocclusive cap (contraceptive diaphragm or cervical / uterine cap). 14. The patient agrees to comply to the trial rpotocols.
Exclusion
Exclusion Criteria:
- Patients received drugs or other cellular immunotherapy in other clinical trialswithin 28 days before the screening period.
- Patients are receiving immunosuppressive therapy for previous or recurrent autoimmunediseases within 14 days before allogeneic natural killer cell infusion.
- The patient suffered from other malignant tumors in the past 5 years (except basalcell carcinoma or squamous cell carcinoma of the skin and carcinoma in situ of thecervix).
- Acute illness in progress, or has been accompanied by serious diseases in the past 2years, such as cardiovascular disease (such as New York Heart Association (NYHA) IIIor IV), mental health problems (e.g. alcohol, drug abuse). Or the program moderatorjudges patients who are not suitable to participate in clinical trials on the basis ofmedical history, physical examination results or test abnormalities that may interferewith the test results or adversely affect the safety of the subjects.
- Allergic to aminoglycosides (Aminoglycoside) or subtilisin (Bacitracin), such asstreptomycin (Streptomycin) and gentamicin (Gentamicin).
- Patient is known to be allergic to any ingredient in the end product of NKpreparation, including human serum albumin.
- Female subjects who are breast-feeding or positive for serum or urine pregnancy testsduring the screening period.
- Pretreatment with steroids or antihistamines cannot be controlled for radiographiccontrast agents (iodinated or non-iodinated) who have a history of allergy or allergicreactions or other clinically significant adverse reactions, and the researchersbelieve that it is not suitable for subjects who undergo conventional computerizedtomography (CT) or magnetic resonance imaging (MRI). And subjects withcontraindications for CT scanning for other reasons (such as strong magnetic implants,severe claustrophobia) should not be included in the group.
Study Design
Connect with a study center
Zibo
Zibo, Shandong 250036
ChinaSite Not Available
Zibo Central Hospital
Zibo, Shandong 250036
ChinaActive - Recruiting

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