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

NCT06982053 | Completed DMC

• 1 other identifier: XLan-0506
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (2)

• 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)

  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

  4 - 6 months.

Study Arms (1)

Received 68Ga-NOTA-GZP PET scanning

EXPERIMENTAL

Diagnostic Test: Received 68Ga-NOTA-GZP PET scanning

Interventions

Received 68Ga-NOTA-GZP PET scanning DIAGNOSTIC_TEST

Received twice 68Ga-NOTA-GZP PET scanning before neoadjuvant therapy and radical surgery.

Also known as: Received 18F-FDG PET scanning

Received 68Ga-NOTA-GZP PET scanning

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Department of Nuclear Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, Hubei Province, China.

Wuhan, 430000, China

Location

MeSH Terms

Conditions

Lipodystrophy, Congenital Generalized; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lipodystrophy; Skin Diseases, Metabolic; Skin Diseases; Skin and Connective Tissue Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 21, 2025
• Study Start: May 6, 2024
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD will be available starting 01/01/2025 with no end date, contingent on repository maintenance and ethical approvals.
• Access Criteria: 1\. Who can access the data? De-identified IPD and supporting documents will be available to researchers with a valid scientific question, provided they: * Submit a methodologically sound proposal (with analysis plan) * Provide proof of ethics approval from their institution * Sign a Data Use Agreement prohibiting re-identification 2\. What data will be shared? * Included: Baseline demographics, outcome measures, safety data, study protocol, and data dictionary * Excluded: Direct identifiers (names, addresses), raw genomic data 3\. How to access? 1. Submit request via email 2. Independent Review Panel evaluates proposals (4-week review period) 3. Approved users receive de-identified data in CSV/SAS format 4. Restrictions * Prohibited: Commercial use, patient re-identification * Required: Citation of original study in publications

Locations

CN (1)