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A prospective study on 68Ga-grazytracer PET/CT evaluation of early immunotherapy response in gastrointestinal tumors

A prospective study on 68Ga-grazytracer PET/CT evaluation of early immunotherapy response in gastrointestinal tumors

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400085362
Enrollment
Unknown
Registered
2024-06-05
Start date
2024-06-10
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastrointestinal malignancy

Interventions

Sponsors

the First Affiliated Hospital of the People's Liberation Army Air Force Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Voluntarily sign an informed consent form. 2. No gender limit, age 18 to 75 years old (including threshold). 3. Gastroesophageal junction/colorectal adenocarcinoma (PD-L1 CPS = 5, MSI-H/dMMR) confirmed by histopathology and meeting the ICI treatment criteria, and confirmed by multiple imaging examinations as locally advanced (T2-4aN0-3M0, corresponding to stages Ib to IIIC). 4. Plan to receive a systemic treatment regimen containing ICI (which must include anti PD-1/PD-L1 monoclonal antibodies). 5. The ECOG (Eastern Cooperative Oncology Group Performance Status score) physical condition score is 0 or 1. 6. According to the patient's existing CT examination, there are measurable target lesions in the RECIST version 1.1 efficacy evaluation criteria.

Exclusion criteria

Exclusion criteria: 1. Patients with secondary primary cancer other than gastrointestinal tumors. 2. Have received any intervention treatment within the previous month. 3. Preexisting history of autoimmune diseases and immunosuppressive drug treatment. 4. Unable to cooperate with lying on the PET/CT scanning bed during the scanning period or intolerant to PET examination. 5. According to the evaluation of the researchers, the subjects may have other circumstances that may affect the study or are not suitable for participation in the study.

Design outcomes

Primary

MeasureTime frame
SUVmax;SUVmean;dNLR;LDH;sensitivity;specificity;accuracy;

Secondary

MeasureTime frame
NLR;(Positive predicative value;Negative predictive value;

Countries

China

Contacts

Public ContactFei Kang

the First Affiliated Hospital of the People's Liberation Army Air Force Military Medical University

2326604944@qq.com+86 29 8477 1048

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026