Status:

COMPLETED

[68Ga]Ga-GZP PET for Early Response Prediction in Colorectal Cancer During Neoadjuvant Therapy

Lead Sponsor:

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Conditions:

Colorectal Cancer Control and Prevention

Colorectal Cancer Recurrent

Eligibility:

All Genders

Phase:

NA

Brief Summary

This diagnostic study investigates the value of 68Ga-NOTA-GZP PET imaging in predicting and evaluating immunotherapy response in malignant tumors by enrolling pathologically confirmed patients schedul...

Detailed Description

Malignant tumors represent one of the leading causes of mortality worldwide, posing a significant threat to human health, where early diagnosis and timely intervention can substantially improve clinic...

Eligibility Criteria

Inclusion

  • Histologically confirmed treatment-naïve locally advanced rectal adenocarcinoma (T3-4N0M0 or T1-4N+M0)
  • No severe hematologic, cardiac, pulmonary, hepatic, or renal dysfunction
  • No immunodeficiency diseases
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

Exclusion

  • Prior anti-PD-1/PD-L1 antibody therapy
  • History of pelvic radiotherapy
  • Active autoimmune disease (excluding vitiligo and type 1 diabetes)
  • Hypersensitivity to monoclonal antibodies
  • History of interstitial lung disease
  • Active uncontrolled infection

Key Trial Info

Start Date :

May 6 2024

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 31 2025

Estimated Enrollment :

21 Patients enrolled

Trial Details

Trial ID

NCT06982053

Start Date

May 6 2024

End Date

March 31 2025

Last Update

May 21 2025

Active Locations (1)

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Department of Nuclear Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, Hubei Province, China.

Wuhan, China, 430000