Clinical trial · Interventional
Clinical Application of Lutetium [177Lu]-Catalase in Tumor Radionuclide Therapy
NCT05985278CI-TRIAL-00068785unknownEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Malignant Neoplasm | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [ Lu-177]-Catalase | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [ Lu-177]-Catalase
- description
- Participants received \[ Lu-177\]-Catalase intratumoral injection
- interventionNames
- Drug: [ Lu-177]-Catalase
Primary outcomes (1)
- measure
- The absorbed radiation dose of tumor and normal organs
- timeFrame
- From first dose of study drug through 8 weeks post dose
- description
- Calculation of effective absorbed dose of tumor in situ injection
Secondary outcomes (1)
- measure
- Preliminary efficacy of [ Lu-177]-Catalase based on tumor response
- timeFrame
- From first dose of study drug through 8 weeks post dose
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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 standard treatment; 4. Expected survival of more than 3 months; 5. 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). 6. 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; 7. 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; 8. Can understand and voluntarily sign informed consent, compliance is good 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
References
Publications (0)
Data not yet available
No reference posted for this study.