Last updated: June 13, 2023
Sponsor: Shanghai Zhongshan Hospital
Overall Status: Active - Recruiting
Phase
N/A
Condition
Liver Metastases
Metastatic Cancer
Digestive System Neoplasms
Treatment
Drug screen with PDO/PDO-TIL/PDOTS
Clinical Study ID
NCT05913141
B2022-063R
Ages 18-90 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- ≥18 years old, male or female.
- Liver cancer or metastatic liver cancer diagnosed clinically or pathologically, atleast one measurable lesion.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
- Patient has given written informed consent.
- The function of important organs meets the requirements.
- Non-surgical sterilization or women of childbearing age need to use amedically-accepted contraceptive (such as an intrauterine device, contraceptive orcondom) during the study period and within 3 months after the end of the studytreatment period.
Exclusion
Exclusion Criteria:
- The patient has any active autoimmune disease or a history of autoimmune disease (suchas the following, but not limited to autoimmune hepatitis, interstitial pneumonia,uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, thyroidHyperfunction; patients with vitiligo; complete remission of asthma in childhood, canbe included without any intervention after adulthood; asthma patients who requirebronchodilators for medical intervention cannot be included).
- The patient is using immunosuppressive agents or systemic hormonal therapy to achieveimmunosuppressive purposes (agents amount > 10 mg/day of prednisone or othertherapeutic hormones), and continue to use within 2 weeks before enrollment.
- Have clinical symptoms or diseases that are not well controlled.
- Significant clinically significant bleeding symptoms or a clear bleeding tendencywithin 3 months prior to randomization.
- Arterial/venous thrombosis in the first 6 months of randomization.
- According to the investigator, the patient has other factors that may affect theresults of the study or lead to the termination of the study, such as alcohol abuse,drug abuse, other serious diseases (including mental illness) requiring combinedtreatment, and serious laboratory abnormalities.
Study Design
Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Drug screen with PDO/PDO-TIL/PDOTS
Phase:
Study Start date:
June 01, 2023
Estimated Completion Date:
June 30, 2026
Connect with a study center
Zhongshan Hospital, Fudan University
Shanghai, Shanghai 200032
ChinaActive - Recruiting
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