Actively Recruiting

Early Phase 1
Age: 18Years - 70Years
All Genders
NCT05985278

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

Led by Peking University Cancer Hospital & Institute · Updated on 2023-08-14

10

Participants Needed

1

Research Sites

153 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female patients aged 18 to 70 years with ECOG score 0 or 1
  • Diagnosed advanced malignant tumors such as liver cancer, ovarian cancer, or prostate cancer confirmed by pathology or cytology
  • Patients with advanced solid tumors who have failed or cannot tolerate standard treatment
  • Expected survival of more than 3 months
  • At least one measurable tumor lesion suitable for intratumoral injection with a longest diameter of 10 mm or more (or lymph nodes with a short diameter of 15 mm or more)
  • Blood tests showing WBC 4.0�d7 10^9/L or neutrophils 1.5�d7 10^9/L, platelets 100�d7 10^9/L, hemoglobin 90 g/L; PT or APTT 1.5 times upper limit of normal
  • Liver and kidney function within specified limits including T-Bil 1.5 times upper limit, ALT/AST 2.5 times upper limit (or 5 times if liver metastasis), ALP 2.5 times upper limit (or 4.5 if bone or liver metastasis), BUN and SCr 1.5 times upper limit
  • Women must use effective contraception during and for 6 months after the study; men must agree to use contraception during and for 6 months after
  • Ability to understand and voluntarily sign informed consent with good compliance
Not Eligible

You will not qualify if you...

  • Severe abnormal liver and kidney function
  • Pregnant or breastfeeding women
  • Unable to lie flat for at least half an hour
  • Refusal to participate in the clinical trial
  • Suffering from claustrophobia or other mental illness
  • Any other conditions the investigator deems unsuitable for participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Zhi Yang

Beijing, Beijing Municipality, China, 100142

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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