Last updated: April 5, 2022
Sponsor: The Affiliated Hospital of Xuzhou Medical University
Overall Status: Active - Recruiting
Phase
1/2
Condition
Abdominal Cancer
Carcinoma
Liver Disorders
Treatment
N/AClinical Study ID
NCT05323201
XYFY2021-KL272-02
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Subjects should be 18-70 years old.
- Subject has adequate performance status as defined by ECOG score of≤ 2.
- Expected life expectancy is no less than 12 weeks.
- Subjects must have histologically or cytologically confirmed unresectable, recurrentand / or metastatic hepatocellular carcinoma (HCC). And tumor tissues are measuredpositive for B7H3 expression.
- Child-Pugh A, B grade.
- Blood routine: white blood cell count≥ 2.5 × 10^9 / L; hemoglobin≥ 9 g/dL; platelet count≥ 50 × 10^9 / L; lymphocyte proportion≥ 15 %;
- Adequate organ function. Patients' main organs ( heart, lung, liver, kidney, etc. )function well: ALT and AST≤ 5 × ULN; ALB≥ 30 g/L; Total bilirubin≤ 2.5 × ULN; Serum creatinine< 220μmol/L; Indoor oxygen saturation ≥ 95 %; Left ventricular ejection fraction≥ 40%;
- No allergic reaction to contrast agents.
- Procurement and T-cell production eligibility: a previously evaluation confirmedautologous peripheral blood mononuclear cells can be used for T-cell production.
- Patients or their legal guardians voluntarily participate in and sign the informedconsent form.
Exclusion
Exclusion Criteria:
- The subject is a pregnant or lactating woman.
- The subjects have infectious diseases (such as HIV, syphilis, active tuberculosis,etc.);
- The subject has active infection or coagulation dysfunction.
- Subjects with previous hepatic encephalopathy.
- The subject is on anticoagulation or antiplatelet therapy.
- The subject is an organ transplant or waiting for transplant.
- Subjects with mental or psychological diseases who cannot cooperate with treatment andefficacy evaluation.
- The subjects are highly allergic or have a history of severe allergies.
- The subject has received chemotherapy/radiotherapy within the past 4 weeks.
- The subject has a history of cellular immunotherapy or antibody therapy.
- The subject is receiving systemic hormone therapy.
- Subjects with systemic infection or severe local infection requiring anti-infectiontreatment.
- The subject has dysfunction of important organs such as heart, lung, brain, liver, andkidney.
- The subject is participating in other clinical research.
- The doctor believes that there are other reasons not to be included in the treatment.
- Unwilling or unable to provide consent/assent for participation in the study.
Study Design
Total Participants: 15
Study Start date:
February 10, 2022
Estimated Completion Date:
February 10, 2027
Study Description
Connect with a study center
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu 221002
ChinaActive - Recruiting

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