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

Last updated: August 2, 2023
Sponsor: Peking University Cancer Hospital & Institute
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

[ Lu-177]-Catalase

Clinical Study ID

NCT05985278
2021KT90
  • Ages 18-70
  • All Genders

Study Summary

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

Inclusion

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 standardtreatment;
  4. Expected survival of more than 3 months;
  5. According to the solid tumor efficacy evaluation criteria , the patient had at leastone 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 forintratumoral 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: Bloodroutine: WBC≥4.0×109L or neutrophil ≥1.5×109L, PLT≥100×109/L, Hb≥90g/L; PT orAPTT≤1.5ULN; Liver and kidney function: T-Bil≤1.5×ULT(upper limit ofnormal),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 afterthe study (effective contraception means sterilization, intrauterine hormone devices,condoms, contraceptives/pills, abstinence or partner vasectomy, etc.); Men shouldconsent to subjects who must use contraception during the study period and for 6months after the end of the study period;
  8. Can understand and voluntarily sign informed consent, compliance is good

Exclusion

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

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: [ Lu-177]-Catalase
Phase: 1
Study Start date:
July 06, 2023
Estimated Completion Date:
June 15, 2026

Study Description

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.

Connect with a study center

  • Zhi Yang

    Beijing, Beijing 100142
    China

    Active - Recruiting

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