An Early Phase 1 interventional study of [ Lu-177]-Catalase in Advanced Malignant Neoplasm, sponsored by Peking University Cancer Hospital & Institute. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-08-14.
Sponsored by Peking University Cancer Hospital & Institute · Early Phase 1, Interventional, and Treatment
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.
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.
Peking University Cancer Hospital & Institute is the lead sponsor of 266 studies on the registry; 128 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
The Exclusion Criteria:
Participants received \[ Lu-177\]-Catalase intratumoral injection
Drug: [ Lu-177]-Catalase
\[ 177Lu\]-Catalase is administered by intratumoral puncture every four weeks, and the specific dose is related to the size of the tumor
The absorbed radiation dose of tumor and normal organs
Calculation of effective absorbed dose of tumor in situ injection
Time frame: From first dose of study drug through 8 weeks post dose
Preliminary efficacy of [ Lu-177]-Catalase based on tumor response
Tumor volume based on RECIST 1.1.
Time frame: From first dose of study drug through 8 weeks post dose
Adverse events for [ Lu-177]-Catalase
Occurrence of adverse events for \[ Lu-177\]-Catalase
Time frame: From first dose of [ Lu-177]-Catalase through 8 weeks post dose.
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jul 2023 (actual). Primary completion is estimated for Jun 2026, 35 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Peking University Cancer Hospital & Institute →