Clinical trial · Interventional
Research on NI-FAPI-04 for the Treatment of Hypoxic and Fibroblast Activation Protein Related Tumors
Exploratory Study of a Novel Dual Target Molecular Probe NI-FAPI-04 for Intra Irradiation Therapy of Hypoxic and Fibroblast Activation Protein Related Tumors
NCT07822347CI-TRIAL-00126340enrolling by invitationPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 17, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260917-000001
Summary
Brief summary (as posted)
Exploring the therapeutic value of a novel dual target molecular probe NI-FAPI-04 PET/CT with hypoxia and fibroblast activation related proteins in fibroblast activation related tumors. This study will lay the foundation for the further application of NI-FAPI-04 in tumor therapy and achieve the integration of molecular targeted probes for diagnosis, treatment, and efficacy monitoring.
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 |
|---|---|---|---|
| Tumor | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Injection of 177Lu-NI-FAPI | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NI-FAPI group
- description
- Injection of \[177Lu\]Lu-NI-FAPI
- interventionNames
- Drug: Injection of 177Lu-NI-FAPI
Primary outcomes (1)
- measure
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
- timeFrame
- 6-8 weeks after administration
- description
- According to CTCAE v5.0, the number of patients who experienced adverse events was counted
Secondary outcomes (3)
- measure
- Visual analysis of PET images before and after treatment
- timeFrame
- 6-8 weeks after administration
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Age between 18-80 years old * Obtain pathological results through surgery or biopsy * Loss of surgical opportunity (distant metastasis, or unsuitability for surgery due to contraindications); The condition still progresses after conventional chemotherapy, radiotherapy, targeted drug therapy, and other treatments (according to RECIST/PERCAST criteria) * Expected survival time greater than 6 months * Baseline \[68Ga\] Ga-NI-FAPI-04 PET/CT imaging reveals high uptake lesions * Informed consent and the ability to accept follow-up * Bone marrow reserve: neutrophil count ≥ 1.5 × 109/L; platelet count ≥ 100 × 109/L; hemoglobin ≥ 90 g/L * Liver function: AST/ALT ≤ 3 × ULN, or subjects with liver metastasis\<5 × ULN; Albumin\>3.0 g/dL; Total bilirubin ≤ 1.5 × ULN * Renal function: creatinine clearance rate ≥ 50 mL/min * Coagulation function: INR ≤ 1.5 (for patients who have not received warfarin treatment); Prothrombin time (PTT)\<2 × ULN Exclusion Criteria: * Pregnant and lactating female patients * Individuals who fear confinement or radiation * Individuals who have received systemic anti-tumor treatment, including chemotherapy or curative radiotherapy, within 4 weeks prior to their first medication, or who have received TKI treatment within 2 weeks * Patients treated with isotopes such as strontium-89, samarium-153, rhenium 186, rhenium 188, radium-223, etc. within 6 months * Individuals who have experienced severe allergic reactions to the components of \[177Lu\] Lu-NI-FAPI-04 injection in the past * Received any investigational medication within 28 days prior to the first dose, or participated in another clinical study at the same time (except for those who participated in observational, non interventional clinical studies, or are currently in the follow-up period of interventional clinical studies) * Patients who are difficult to receive further diagnosis and treatment due to severe illness
References
Publications (0)
Data not yet available
No reference posted for this study.