Clinical trial · Interventional
[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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer Control and Prevention | — | UNRESOLVED | — |
| Colorectal Cancer Metastatic | — | UNRESOLVED | — |
| Colorectal Cancer Recurrent | — | UNRESOLVED | — |
| Colorectal Cancer Screening | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Received 68Ga-NOTA-GZP PET scanning | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Received 68Ga-NOTA-GZP PET scanning
- interventionNames
- Diagnostic Test: Received 68Ga-NOTA-GZP PET scanning
Primary outcomes (2)
- measure
- Clinical response
- timeFrame
- 4 - 6 months.
- description
- Proportion of participants achieving clinical complete response, defined as the absence of detectable tumor residues in both primary lesions and regional lymph nodes through standardized post-neoadjuvant diagnostic evaluations including: Endoscopic ultrasound (EUS) Pelvic MRI (T2-weighted imaging with diffusion-weighted sequences) Chest/abdominal CT (RECIST 1.1 criteria)
- measure
- Pathological response
- timeFrame
- 4 - 6 months.
- description
- Pathological complete response (pCR) rate determined by histopathological examination * ypT0 (no viable tumor cells in primary tumor specimen) * ypN0 (no tumor cells in regional lymph nodes) Mandatory whole-mount sectioning of surgical specimens according to CAP (College of American Pathologists) protocol
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available