Last updated: August 2, 2023
Sponsor: Peking University Cancer Hospital & Institute
Overall Status: Active - Recruiting
Phase
1
Condition
Neoplasms
Treatment
[ Lu-177]-Catalase
Clinical Study ID
NCT05985278
2021KT90
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male or female patients, aged 18-70 years; ECOG score 0 or 1;
- Patients with advanced malignant tumors, such as liver cancer, ovarian cancer,prostate cancer, and so on, clearly diagnosed by pathology and/or cytology;
- Patients with advanced solid tumors who have failed or cannot tolerate standardtreatment;
- Expected survival of more than 3 months;
- According to the solid tumor efficacy evaluation criteria , the patient had at leastone measurable or evaluable tumor lesion with the longest diameter ≥10 mm at baseline (in the case of lymph nodes, the short diameter ≥15 mm). This lesion is suitable forintratumoral injection (the length of the lesion is at least 1 cm or equal).
- Blood routine and liver and kidney function meet the following criteria: Bloodroutine: WBC≥4.0×109L or neutrophil ≥1.5×109L, PLT≥100×109/L, Hb≥90g/L; PT orAPTT≤1.5ULN; Liver and kidney function: T-Bil≤1.5×ULT(upper limit ofnormal),ALT/AST≤2.5ULN or ≤5×ULT(subjects with liver metastasis), ALP≤2.5ULN(ALP≤ 4.5ULN if there is bone metastasis or liver metastasis); BUN≤1.5×ULT, SCr≤1.5×ULT;
- Women must use effective contraception during the study period and for 6 months afterthe study (effective contraception means sterilization, intrauterine hormone devices,condoms, contraceptives/pills, abstinence or partner vasectomy, etc.); Men shouldconsent to subjects who must use contraception during the study period and for 6months after the end of the study period;
- Can understand and voluntarily sign informed consent, compliance is good
Exclusion
The Exclusion Criteria:
- Severe abnormal liver and kidney function;
- Pregnant, pregnant and lactating women;
- Can not lie flat for half an hour;
- Refuse to join the clinical investigator;
- Suffering from claustrophobia or other mental illness;
- Other conditions deemed unsuitable for participation in the trial by the investigator
Study Design
Total Participants: 10
Treatment Group(s): 1
Primary Treatment: [ Lu-177]-Catalase
Phase: 1
Study Start date:
July 06, 2023
Estimated Completion Date:
June 15, 2026
Study Description
Connect with a study center
Zhi Yang
Beijing, Beijing 100142
ChinaActive - Recruiting
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