[68Ga]Ga-GZP PET for Early Response Prediction in Colorectal Cancer During Neoadjuvant Therapy (NCT06982053) | Clinical Trial Compass
CompletedNot Applicable
[68Ga]Ga-GZP PET for Early Response Prediction in Colorectal Cancer During Neoadjuvant Therapy
China21 participantsStarted 2024-05-06
Plain-language 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 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical response
Timeframe: 4 - 6 months.
2
Pathological response
Timeframe: 4 - 6 months.
Trial details
NCT IDNCT06982053
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology