To hear about similar clinical trials, please enter your email below
Trial Title:
Clinical Application of Lutetium [177Lu]-Catalase in Tumor Radionuclide Therapy
NCT ID:
NCT05985278
Condition:
Advanced Malignant Neoplasm
Conditions: Official terms:
Neoplasms
Catalase
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
[ Lu-177]-Catalase
Description:
[ 177Lu]-Catalase is administered by intratumoral puncture every four weeks, and the
specific dose is related to the size of the tumor
Arm group label:
[ Lu-177]-Catalase
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhi Yang
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhi Yang, PhD
Phone:
01088196196
Email:
pekyz@163.com
Contact backup:
Last name:
Xiaoyi GUO, PhD
Phone:
01088196495
Email:
2216392114@bjmu.edu.cn
Start date:
July 6, 2023
Completion date:
June 15, 2026
Lead sponsor:
Agency:
Peking University Cancer Hospital & Institute
Agency class:
Other
Source:
Peking University Cancer Hospital & Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05985278
