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

NCT ID: NCT05985278

Last Updated: 2023-08-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-06
• Study Completion Date: 2026-06-15

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.

Conditions

Advanced Malignant Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

[ Lu-177]-Catalase

Participants received \[ Lu-177\]-Catalase intratumoral injection

Group Type: EXPERIMENTAL

[ Lu-177]-Catalase

Intervention Type: DRUG

\[ 177Lu\]-Catalase is administered by intratumoral puncture every four weeks, and the specific dose is related to the size of the tumor

Interventions

[ 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

Intervention Type: DRUG

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhi Yang

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Zhi Yang, PhD

Role: primary

pekyz@163.com

01088196196

Xiaoyi GUO, PhD

Role: backup

2216392114@bjmu.edu.cn

01088196495

Other Identifiers

2021KT90

Identifier Type: -

Identifier Source: org_study_id