Enfortumab Vedotin in Patients With Advanced Small Bowel Adenocarcinoma Refractory or Into
Small bowel adenocarcinoma is a rare cancer with a poor prognosis. For patients with locally advanced or metastatic disease, the usual first treatment is chemotherapy with platinum-based combinations such as FOLFOX or CapeOX. However, once the cancer grows after this treatment or the side effects become too severe, the
| Condition(s) | Advanced Small Bowel Adenocarcinoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | Small bowel adenocarcinoma is a rare cancer with a poor prognosis. For patients with locally advanced or metastatic disease, the usual first treatment is chemotherapy with platinum-based combinations such as FOLFOX or CapeOX. However, once the cancer grows after this treatment or the side effects become too severe, there is no widely accepted standard second-line therapy, and outcomes are generally poor. New treatment options are therefore urgently needed. Recent retrospective research from our group has shown that the majority of the small bowel adenocarcinomas strongly express a protein called Nectin-4 on the surface of cancer cells. High Nectin-4 expression was also associated with poorer survival, suggesting that Nectin-4 could be a crucial treatment target in this disease. Enfortumab |
| Who can participate | Inclusion Criteria: 1. Histologically or cytologically confirmed small bowel adenocarcinoma (duodenum excluding the ampulla of Vater, jejunum, or ileum). If pathology was performed at another institution, slides/blocks must be reviewed by a pathologist at the study site before enrollment. 2. One of the following: 1. unresectable locally advanced small bowel adenocarcinoma in which R0 resection would require combined resection of invaded organs and is judged infeasible 2. UICC-TNM stage IV small bowel adenocarcinoma with distant metastasis 3. postoperative recurrence of small bowel adenocarcinoma. 3. No symptomatic brain metastases, carcinomatous meningitis, or spinal metastases requiring radiation or surgical intervention. 4. No clinically significant pericardial effusion, pleural effusion |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | National Cancer Center, Japan |
| Locations | Fukuoka, Japan; Osaka, Japan; Tokyo, Japan |
| Start date | 2025-11-04 |
| NCT ID | NCT07347314 |
| Official listing | https://clinicaltrials.gov/study/NCT07347314 |