Clinical trial · Observational
FAPI PET for Response Evaluation and Prognosis Prediction in Liver and Biliary Cancer Patients Treated With PD-1 Combination Therapy
68Ga-FAPI PET for Response Evaluation and Prognosis Prediction in Advanced Liver and Biliary Cancer Patients Treated With PD-1 Based Combination Therapy: A Head-to-head Comparison to 18F-FDG PET
NCT05662488CI-TRIAL-00062844unknownClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to explore the ability of positron emission tomography (PET) with \[68Ga\]FAPI to detect, evaluate treatment response, and predict prognosis in advanced liver and biliary cancer patients treated with anti-PD-1 antibodies-based combination therapy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bile Duct Cancer | Malignant Bile Duct Neoplasm | CURATED_BROADER | 0.80 |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [68Ga]FAPI PET/CT and [18F]FDG PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (6)
- measure
- Baseline SUVmax on [68Ga]FAPI and [18F] FDG PET Scans
- timeFrame
- through study completion, an average of 2 years
- description
- Baseline FAPI and FDG SUVmax, fibro-activation tumor volume (metabolic tumor volume), total lesion fibro-activation (total lesion glycolysis) before treatment were determined.
- measure
- Baseline active tumor volume on [68Ga]FAPI and [18F] FDG PET Scans
- timeFrame
- through study completion, an average of 2 years
- description
- Baseline fibro-activation tumor volume and metabolic tumor volume before treatment were determined.
- measure
- Baseline total lesion activation on [68Ga]FAPI and [18F] FDG PET Scans
- timeFrame
- through study completion, an average of 2 years
- description
- Baseline total lesion fibro-activation and total lesion glycolysis before treatment were determined.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * locally advanced or metastatic and/or unresectable HCC or BTC * Child Pugh A or B liver function status * an ECOG performance status score of 0-2 Exclusion Criteria: * intolerance to anti-PD-1-based combination therapy * active or prior autoimmune disease * concurrent use of immunosuppressive medicaments
References
Publications (0)
Data not yet available
No reference posted for this study.