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

Study Overview
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Brief Summary
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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.

Detailed Description
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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, patients who meet the eligibility requirements will be intratumoral injection the [Lu-177]-Catalase.The efficacy evaluation will be conducted at one month p.i., whether to continue intratumoral injection the [Lu-177]-Catalase, depending on the patient's efficacy and safety results.

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

Conditions
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Advanced Malignant Neoplasm

Intervention / Treatment
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* Drug: [ Lu-177]-Catalase


Participation Criteria
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Eligibility Criteria
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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 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [ Lu-177]-Catalase<br>Participants received [ Lu-177]-Catalase intratumoral injection | Drug: [ Lu-177]-Catalase<br>* [ 177Lu]-Catalase is administered by intratumoral puncture every four weeks, and the specific dose is related to the size of the tumor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The absorbed radiation dose of tumor and normal organs | Calculation of effective absorbed dose of tumor in situ injection | From first dose of study drug through 8 weeks post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preliminary efficacy of [ Lu-177]-Catalase based on tumor response | Tumor volume based on RECIST 1.1. | From first dose of study drug through 8 weeks post dose |