About this trial
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 \[Lu-177\]-Catalase.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Single group
Treatments tested in this trial
[ Lu-177]-Catalase
Drug\[ 177Lu\]-Catalase is administered by intratumoral puncture every four weeks, and the specific dose is related to the size of the tumor
Treatment groups
Trial outcomes
Primary outcomes
The absorbed radiation dose of tumor and normal organs
Calculation of effective absorbed dose of tumor in situ injection
Secondary outcomes
Preliminary efficacy of [ Lu-177]-Catalase based on tumor response
Tumor volume based on RECIST 1.1.
Other outcomes
Adverse events for [ Lu-177]-Catalase
Occurrence of adverse events for \[ Lu-177\]-Catalase
Sponsors and contacts
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