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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorPeking University Cancer Hospital & Institute

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 volunteers

Qualifiers

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

Design model

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

10 Participants
are divided into 1 treatment group
Group A: [ Lu-177]-CatalaseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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

Other outcomes

1

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.

Sponsors and contacts

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