Colorectal Cancer Control and PreventionNCT06982053
[68Ga]Ga-GZP PET for Early Response Prediction in Colorectal Cancer During Neoadjuvant Therapy
A study testing Received 68Ga-NOTA-GZP PET scanning in people with Colorectal Cancer Control and Prevention and Colorectal Cancer Recurrent, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Cancer Control and Prevention, Colorectal Cancer Recurrent, Colorectal Cancer Metastatic
- What is being tested?
- Received 68Ga-NOTA-GZP PET scanning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 6 May 2024to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Nuclear Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, Hubei Province, China.
Wuhan, 430000
About this study
Official title: [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
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.
Read the 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 clinical outcomes. In recent years, immunotherapy has emerged as a cornerstone in comprehensive cancer treatment, with immune checkpoint inhibitors (ICIs) serving as a primary therapeutic modality. ICIs function by targeting regulatory pathways of T cells, specifically through blockade of immune checkpoints to enhance cytotoxic T cell activity and thereby elicit anti-tumor immune responses. However, the clinical benefits remain limited to a subset of patients, with many eventually experiencing disease progression or recurrence. Given the heterogeneous response patterns observed during immunotherapy, early and dynamic treatment response assessment becomes paramount - early identification of responders versus non-responders enables timely stratification of patients to avoid ineffective treatments, while continuous monitoring allows for comprehensive evaluation of tumor response patterns to minimize unnecessary adverse effects.
The cytotoxic lymphocytes play a pivotal role in anti-tumor immunity, with granzyme B, a serine protease released by activated cytotoxic lymphocytes during immune responses, representing one of the two principal mechanisms through which lymphocytes mediate cancer cell apoptosis. The quantification of granzyme B directly reflects the activity status of cytotoxic lymphocytes. Compared to general immune cell infiltration assessments, measuring active immune cell populations provides a more precise indicator of immune response intensity and greater predictive value for immunotherapy outcomes. The development of 68Ga-NOTA-GZP, a 68Ga-labeled peptide specifically targeting granzyme B, enables non-invasive visualization of cytotoxic lymphocyte activity. This novel PET tracer shows potential for early differentiation between treatment responders and non-responders, facilitating prompt clinical decision-making to discontinue ineffective therapies.
Building upon the promising potential of 68Ga-NOTA-GZP in immunotherapy monitoring, this study aims to systematically evaluate its efficacy in predicting and assessing treatment responses in malignant tumors. Using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) and immune-modified RECIST (iRECIST) as reference standards, we will investigate the tracer's capability for early treatment response prediction and real-time monitoring, with the ultimate goals of accurately stratifying patients at the earliest timepoint and minimizing unnecessary immunotherapy-related toxicities.
- Conditions
- Colorectal Cancer Control and Prevention, Colorectal Cancer Recurrent, Colorectal Cancer Metastatic, Colorectal Cancer Screening
- Being tested
- Received 68Ga-NOTA-GZP PET scanning
- Keywords
- Neoadjuvant therapy, Immunotherapy, PET, PET/CT, PET/MR, Granzyme B, Colorectal cancer, Locally advanced rectal cancer
- Medical subject headings
- Lipodystrophy, Congenital Generalized, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Received 68Ga-NOTA-GZP PET scanningDiagnostic test
Also called Received 18F-FDG PET scanning
Received twice 68Ga-NOTA-GZP PET scanning before neoadjuvant therapy and radical surgery.
| Study group | Role | What they receive |
|---|---|---|
| Received 68Ga-NOTA-GZP PET scanning | Experimental | Not described Receives: Diagnostic Test: Received 68Ga-NOTA-GZP PET scanning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response
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)
Measured: 4 - 6 months.
Pathological response
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
Measured: 4 - 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start6 May 2024
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer Control and PreventionStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06982053
- Sponsor's protocol ID
- XLan-0506
- Status last verified
- May 2025
- First submitted
- 9 May 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in primary and secondary outcomes of the study, including: * Baseline demographics (age, sex, race) * Clinical characteristics (tumor stage, biomarker status) * Efficacy outcomes (response rates, progression-free survival) * Safety data (adverse events, laboratory parameters) * Associated documents * PET parameters
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [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
- ClinicalTrials.gov ID
- NCT06982053
- Acronym / sponsor ID
- XLan-0506
- Conditions
- Colorectal Cancer Control and Prevention, Colorectal Cancer Recurrent, Colorectal Cancer Metastatic, Colorectal Cancer Screening
- Keywords
- Neoadjuvant therapy, Immunotherapy, PET, PET/CT, PET/MR, Granzyme B, Colorectal cancer, Locally advanced rectal cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 6 May 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 clinical outcomes. In recent years, immunotherapy has emerged as a cornerstone in comprehensive cancer treatment, with immune checkpoint inhibitors (ICIs) serving as a primary therapeutic modality. ICIs function by targeting regulatory pathways of T cells, specifically through blockade of immune checkpoints to enhance cytotoxic T cell activity and thereby elicit anti-tumor immune responses. However, the clinical benefits remain limited to a subset of patients, with many eventually experiencing disease progression or recurrence. Given the heterogeneous response patterns observed during immunotherapy, early and dynamic treatment response assessment becomes paramount - early identification of responders versus non-responders enables timely stratification of patients to avoid ineffective treatments, while continuous monitoring allows for comprehensive evaluation of tumor response patterns to minimize unnecessary adverse effects.
The cytotoxic lymphocytes play a pivotal role in anti-tumor immunity, with granzyme B, a serine protease released by activated cytotoxic lymphocytes during immune responses, representing one of the two principal mechanisms through which lymphocytes mediate cancer cell apoptosis. The quantification of granzyme B directly reflects the activity status of cytotoxic lymphocytes. Compared to general immune cell infiltration assessments, measuring active immune cell populations provides a more precise indicator of immune response intensity and greater predictive value for immunotherapy outcomes. The development of 68Ga-NOTA-GZP, a 68Ga-labeled peptide specifically targeting granzyme B, enables non-invasive visualization of cytotoxic lymphocyte activity. This novel PET tracer shows potential for early differentiation between treatment responders and non-responders, facilitating prompt clinical decision-making to discontinue ineffective therapies.
Building upon the promising potential of 68Ga-NOTA-GZP in immunotherapy monitoring, this study aims to systematically evaluate its efficacy in predicting and assessing treatment responses in malignant tumors. Using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) and immune-modified RECIST (iRECIST) as reference standards, we will investigate the tracer's capability for early treatment response prediction and real-time monitoring, with the ultimate goals of accurately stratifying patients at the earliest timepoint and minimizing unnecessary immunotherapy-related toxicities.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Received 68Ga-NOTA-GZP PET scanning | Experimental | Diagnostic Test: Received 68Ga-NOTA-GZP PET scanning |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Received 68Ga-NOTA-GZP PET scanningAlso: Received 18F-FDG PET scanningReceived twice 68Ga-NOTA-GZP PET scanning before neoadjuvant therapy and radical surgery. | Diagnostic test | Received 68Ga-NOTA-GZP PET scanning |
Primary outcome
Clinical response
Time frame: 4 - 6 months.
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)
Pathological response
Time frame: 4 - 6 months.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in primary and secondary outcomes of the study, including: * Baseline demographics (age, sex, race) * Clinical characteristics (tumor stage, biomarker status) * Efficacy outcomes (response rates, progression-free survival) * Safety data (adverse events, laboratory parameters) * Associated documents * PET parameters
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Received 68Ga-NOTA-GZP PET scanning in people with Colorectal Cancer Control and Prevention and Colorectal Cancer Recurrent, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response (time frame: 4 - 6 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.