NCT06982053Completed
[68Ga]Ga-GZP PET for Early Response Prediction in Colorectal Cancer During Neoadjuvant Therapy
[68Ga]Ga-GZP PET and [18F]FDG PET for Early Response Prediction in Locally Advanced Rectal Cancer Undergoing Neoadjuvant Short-Course Radiotherapy Plus Immunochemotherapy: A Single-center Clinical Study
Source: ClinicalTrials.gov · Last updated 21 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 21 (actual)
- First submitted
- 9 May 2025
- Start date
- 6 May 2024
- Primary completion date
- 31 Mar 2025
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Diseases
- Colorectal cancer, Childhood cancers
- NCT number
- NCT06982053
What you commit to
- Study type: Interventional
- Participants enrolled: 21
- From 6 May 2024 to the primary completion date, 31 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior anti-PD-1/PD-L1 antibody therapy
Other illness
- 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
Who the study is looking for
- 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
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Nuclear Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, Hubei Province, China. Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.