Status:
RECRUITING
Clinical Application of Lutetium [177Lu]-Catalase in Tumor Radionuclide Therapy
Lead Sponsor:
Peking University Cancer Hospital & Institute
Conditions:
Advanced Malignant Neoplasm
Eligibility:
All Genders
18-70 years
Phase:
EARLY_PHASE1
Brief Summary
The purpose of this study is to evaluate the retention in tumour and distribution behavior of \[Lu-177\]-Catalase after intratumoral injection,and preliminary evaluation the efficacy and safety of \[L...
Detailed Description
After being informed about the study and potential risks, all patients giving written informed consent will undergo a 2-week screening period to determine eligibility for study entry. At day1, patient...
Eligibility Criteria
Inclusion
- 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 standard treatment;
- Expected survival of more than 3 months;
- According to the solid tumor efficacy evaluation criteria , the patient had at least one 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 for intratumoral injection (the length of the lesion is at least 1 cm or equal).
- Blood routine and liver and kidney function meet the following criteria: Blood routine: WBC≥4.0×109L or neutrophil ≥1.5×109L, PLT≥100×109/L, Hb≥90g/L; PT or APTT≤1.5ULN; Liver and kidney function: T-Bil≤1.5×ULT(upper limit of normal),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 after the study (effective contraception means sterilization, intrauterine hormone devices, condoms, contraceptives/pills, abstinence or partner vasectomy, etc.); Men should consent to subjects who must use contraception during the study period and for 6 months after the end of the study period;
- Can understand and voluntarily sign informed consent, compliance is good
- The
Exclusion
- 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
Key Trial Info
Start Date :
July 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 15 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05985278
Start Date
July 6 2023
End Date
June 15 2026
Last Update
August 14 2023
Active Locations (1)
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1
Zhi Yang
Beijing, Beijing Municipality, China, 100142