Clinical Trial · NCT06982053

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

Overview

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 scheduled for immunotherapy and healthy volunteers. All participants underwent immunohistochemical staining of tumor tissue for immune checkpoint markers (PD-1 or CTLA-4) and granzyme B expression prior to signing informed consent for 68Ga-NOTA-GZP PET imaging. Patients received baseline scans before initial immunotherapy and follow-up scans during treatment cycles 2-4, with clinical monitoring continuing until 6 months post-treatment, while healthy volunteers completed single scans with pharmacokinetic analysis through serial blood/urine sampling. Comprehensive data collection included demographic information, clinical characteristics, immunohistochemistry results, laboratory tests (blood routine, liver/kidney function), PET imaging findings, and other relevant imaging data, with treatment response ultimately assessed according to RECIST 1.1 and iRECIST criteria at the 6-month follow-up endpoint.

Sponsor

Norwegian University of Science and Technology

Phase

N/A

ClinicalTrials.gov

NCT06982053

Drug / Compound

GZP

Isotope(s):

Target(s):

Granzyme B

Ligand Class: Peptides

Chelator: NOTA

Eligibility

Inclusion

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

Exclusion

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