Advanced Malignant Neoplasm
Conditions
Brief 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.
Detailed 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.
Interventions
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
Sponsors
Peking University Cancer Hospital & Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The absorbed radiation dose of tumor and normal organs | From first dose of study drug through 8 weeks post dose | Calculation of effective absorbed dose of tumor in situ injection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preliminary efficacy of [ Lu-177]-Catalase based on tumor response | From first dose of study drug through 8 weeks post dose | Tumor volume based on RECIST 1.1. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse events for [ Lu-177]-Catalase | From first dose of [ Lu-177]-Catalase through 8 weeks post dose. | Occurrence of adverse events for \[ Lu-177\]-Catalase |
Countries
China
Outcome results
None listed