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Automated Preparation of [68Ga]Ga-3BP-3940 on a Synthesis Module for PET Imaging of the Tumor Microenvironment
Published on: April 25, 2025
Efficacy and Safety of Fibroblast Activation Protein Targeted Radioligand Therapy for Advanced Solid Tumour: A
Xiaoli Zhang1,2, Jianpeng Cao1, Xue Jiang1
1Department of Nuclear Medicine, China National Nuclear Corporation 416 Hospital, The Second Affiliated Hospital of Chengdu Medical College, Chengdu, Sichuan, P. R. China.
Objective:
Fibroblast activation protein (FAP) is a promising cancer theranostic target. While FAP-based diagnostics have proven highly accurate, the efficacy and safety of FAP-targeted radioligand therapy (FAP-RLT) for advanced, treatment-refractory solid tumours are poorly characterized.
Methods:
We performed a systematic review and meta-analysis of clinical trials reporting therapeutic outcomes and adverse events of FAP-RLT up to 25 January 2025 (PubMed, ClinicalTrials.gov, Cochrane Library, Web of Science/MEDLINE). Primary endpoints were objective response rate (ORR), disease control rate (DCR), and incidence of grade ≥ 3 adverse events.
Results:
The objective response rate of FAP-RLT treatment was 11.7% (95%CI: 3.2%-23.2%; p < 0.001), and the disease control rate reached 44.4% (95%CI: 25.2%-64.5%; p = 0.004). Specifically, peptide ligands demonstrated superior therapeutic efficacy compared to small molecule ligands. Among radionuclides, 177Lu exhibited better outcomes than 90Y. In specific tumour types, patients with iodine-refractory thyroid cancer derived the greatest benefit from FAP-RLT, followed by those with lung cancer, sarcomas, and breast cancer. Conversely, patients with colorectal cancer and pancreatic cancer exhibited limited therapeutic responses. The pooled median overall survival was 7.26 months, while the median progression-free survival was 4.77 months. Grade ≥ 3 adverse reactions were observed in 2.2% (95%CI: 0.1%-6.0%; p = 0.018) of the cases, 11 out of 222 patients, mostly caused by hematotoxicity.
Conclusion:
FAP-RLT has demonstrated significant disease control in multiple advanced solid tumours while maintaining a favourable safety profile. These findings can contribute to clinical treatment expectations and support informed policy decision-making in oncology.
Insights
Fibroblast activation protein-targeted radioligand therapy (FAP-RLT) shows significant disease control in advanced solid tumors. While effective for certain cancers like thyroid and lung, its safety profile remains favorable, aiding clinical expectations.
Area of Science:
- Oncology
- Radiopharmaceutical Therapy
- Cancer Theranostics
Background:
- Fibroblast activation protein (FAP) is a key target for cancer theranostics.
- FAP-based diagnostics are accurate, but FAP-targeted radioligand therapy (FAP-RLT) efficacy and safety in advanced solid tumors are not well-defined.
Purpose of the Study:
- To systematically review and meta-analyze clinical trial data on FAP-RLT.
- To assess therapeutic outcomes (ORR, DCR) and adverse events of FAP-RLT.
Main Methods:
- Systematic review and meta-analysis of clinical trials up to January 2025.
- Databases searched: PubMed, ClinicalTrials.gov, Cochrane Library, Web of Science/MEDLINE.
- Primary endpoints: objective response rate (ORR), disease control rate (DCR), and grade ≥ 3 adverse events.
Main Results:
- FAP-RLT achieved an ORR of 11.7% and DCR of 44.4%.
- Peptide ligands and 177Lu showed superior efficacy. Best responses seen in thyroid, lung, sarcoma, and breast cancers; limited response in colorectal and pancreatic cancers.
- Median overall survival was 7.26 months, median progression-free survival was 4.77 months. Grade ≥ 3 adverse events occurred in 2.2% of patients, primarily hematotoxicity.
Conclusions:
- FAP-RLT demonstrates significant disease control in advanced solid tumors with a favorable safety profile.
- Findings support clinical treatment expectations and inform oncology policy decisions.
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