Clinical trial · Interventional
The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies.
Whether 18F-ALF-NOTA-PRGD2 PET/CT Scan Can Predict the Efficacy and Adverse Events of Apatinib in Patients With Malignancies.
- 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 is an open-label, single arm study to explore whether 18F-ALF-NOTA-PRGD2 PET/CT scan can predict the efficacy and adverse events of apatinib in patients with malignancies. Integrin αvβ3 has been shown to play an important role in angiogenesis and up-regulated obviously in various types of tumor cells and activated endothelial cells. The arginine-glycine-aspartic acid (RGD) tripeptide sequence can bind to integrin αvβ3 with high affinity and specificity. The 18F-ALF-NOTA-PRGD2 will highly combine with αvβ3, and thus will monitor the antiangiogenic status.In the current study, investigators propose to evaluate the feasibility of 18F-RGD PET/CT in monitoring efficacy and adverse events of apatinib in malignancies.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Malignancies | — | UNRESOLVED | — |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Ovary Cancer | — | UNRESOLVED | — |
| Stomach Cancer | Malignant Gastric Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apatinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Apatinib & RGD PET/CT
- description
- All of the patients will receive apatinib at oral dose of 250 mg twice daily (500 mg/day) at least 30 days.One treatment cycle is defined as 4 weeks.18F-ALF-NOTA-PRGD2 PET/CT scan will be performed berore and after one cycle of therapy. Treatment interruptions or dose reductions to 250 mg/day will be allowed for the management of adverse events. The maximum allowable period of treatment interruption is 1 week during each treatment cycle, and the dose should be re-escalated to 500 mg/day after adverse events mitigation. Treatment will not stop until disease progression, intolerable toxicity, or patients' request for withdrawal from the study.
- interventionNames
- Drug: Apatinib
Primary outcomes (1)
- measure
- Tumor response defined by RECIST criteria
- timeFrame
- At 1 month of the study
- description
- Tumor response will be evaluated as complete response or partial response or stable disease or PD according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Clinical diagnosis of malignancies * Scheduled for second- or third-line apatinib therapy * Karnofsky performance status (KPS) ≥70 * Measurable primary tumors according to Response Evaluation Criteria in Solid Tumors (RECIST) Exclusion Criteria: * Active infection, myocardial infarction within 6 months, symptoms of heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmias, immunosuppressive therapy * The claustrophobic patients and patients with implanted metal objects * The pregnancy * Inability to complete the required examinations
References
Publications (0)
Data not yet available