Clinical Application of Lutetium [177Lu]-Catalase in Tumor Radionuclide Therapy

Launched by PEKING UNIVERSITY CANCER HOSPITAL & INSTITUTE · Aug 2, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment called Lutetium [177Lu]-Catalase for patients with advanced cancers, which are serious tumors that haven't responded to standard treatments. The main goal is to see how well this treatment stays in the tumor after being injected directly into it and to evaluate its safety and effectiveness. The trial is currently looking for participants between the ages of 18 and 70 who have specific types of advanced cancers, such as liver, ovarian, or prostate cancer, and who have not had success with other therapies.

If you or a family member are considering participating, you should know that participants need to have a measurable tumor that can be injected and must be in good enough health to handle the study. There are some health criteria to meet, such as having stable blood counts and liver and kidney function. Participants will be closely monitored throughout the trial for their health and safety. This trial is an important step in finding new ways to treat advanced cancers and could potentially lead to better options for patients in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female patients, aged 18-70 years; ECOG score 0 or 1;
• • 2. Patients with advanced malignant tumors, such as liver cancer, ovarian cancer, prostate cancer, and so on, clearly diagnosed by pathology and/or cytology;
• • 3. Patients with advanced solid tumors who have failed or cannot tolerate standard treatment;
• • 4. Expected survival of more than 3 months;
• • 5. 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).
• • 6. 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;
• • 7. 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;
• • 8. Can understand and voluntarily sign informed consent, compliance is good
• The Exclusion Criteria:
• • 1. Severe abnormal liver and kidney function;
• • 2. Pregnant, pregnant and lactating women;
• • 3. Can not lie flat for half an hour;
• • 4. Refuse to join the clinical investigator;
• • 5. Suffering from claustrophobia or other mental illness;
• • 6. Other conditions deemed unsuitable for participation in the trial by the investigator