Clinical trial · Interventional
68Ga-FAPI-04 PET Imaging in Early Response Evaluation of Rectal Cancer Patients Treated With Immunotherapy
68Ga-FAPI-04 PET Imaging in Early Response Evaluation of Rectal Cancer Patients Treated With Immunotherapy: 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 study is a prospective monocentric study aimed to explore the value of 68Ga-FAPI-04 PET imaging in early response evaluation of rectal cancer patients treated with immunotherapy. Patients with histopathologically confirmed diagnosis of rectal cancer will be recruited and undergo 68Ga-FAPI-04 and 18F-FDG PET imaging before treatment and after short-course radiotherapy and two cycles of neoadjuvant chemotherapy plus immunotherapy. The two imaging intervals will be completed two days apart. The efficacy of 68Ga-FAPI-04 in early response evaluation will be compared with the general imaging agent 18F-FDG. The general information, clinical data, mpMRI data, 68Ga-FAPI-04 and 18F-FDG PET imaging results and other imaging data of the patients will be collected. The histopathology of the biopsy or surgical specimen after 2 cycles of therapy and follow-up data will be taken as evaluation references. This study plans to set the sample size as 20 cases
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-FDG | Drug | — | UNRESOLVED |
| 68Ga-FAPI-04 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Immunotherapy
- description
- Patients with rectal cancer will receive short-course radiotherapy and neoadjuvant chemotherapy plus immunotherapy. 68Ga-FAPI-04 and 18F-FDG PET will be performed at baseline and after short-course radiotherapy and 2 cycles of neoadjuvant chemotherapy plus immunotherapy. The two imaging intervals will be completed two days apart.
- interventionNames
- Drug: 68Ga-FAPI-04
- Drug: 18F-FDG
Primary outcomes (2)
- measure
- 68Ga-FAPI-04 PET analysis
- timeFrame
- Baseline and 21-28 days after 2 cycles of neoadjuvant chemotherapy plus immunotherapy (each cycle is 21-28 days)
- description
- PET parameter (SUVmax in g/ml, MTV in cm3, TLG in g/ml×cm3, etc.) changes between both scans will be measured.
- measure
- 18F-FDG PET analysis
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed T3-4N0M0 or T1-4N+M0 (according to the 8th edition of the International Union Against Cancer TNM staging system) rectal adenocarcinoma and treatment naïve; * No severe hematologic, cardiac, pulmonary, hepatic, or renal functional abnormalities or immunodeficiency diseases; * An Eastern Cooperative Oncology Group Performance Status of 0-1; * Patients who agree to undergo 68Ga-FAPI-04 and 18F-FDG PET imaging. Exclusion Criteria: * Any experiences of anti-programmed death ligand 1 (PD-L1) or anti-PD-1 antibody treatment; * A history of pelvic radiation; * The presence of autoimmune disease; * Hypersensitive to any monoclonal antibodies; * History of interstitial lung disease; * Active and uncontrolled infection.
References
Publications (1)
- DERIVEDZhang X, Lin Z, Feng Y, Lin Z, Tao K, Zhang T, Lan X. Predicting Pathologic Complete Response in Locally Advanced Rectal Cancer with [68Ga]Ga-FAPI-04 PET, [18F]FDG PET, and Contrast-Enhanced MRI: Lesion-to-Lesion Comparison with Pathology. J Nucl Med. 2024 Oct 1;65(10):1548-1556. doi: 10.2967/jnumed.124.267581. PMID 39353648