drugset / Trial / NCT07213557
Simvastatin Efficacy in ARID1A Mutated Advanced gastroESophageal Carcinoma Treated With Immunotherapy
RandomizedParallel-groupOpen-labelTreatment
Summary
The investigators hypothesize that simvastatin (SIM) may improve the efficacy of first- line Nivolumab and Oxaliplatin-based chemotherapy, extending progression-free survival (PFS) as compared with Nivolumab and chemotherapy alone in patients with HER2 negative and ARID1A mutated advanced gastrooesophageal carcinoma (aGEC). Correlative mechanistic studies on tissue and blood samples, could help understanding the evolutionary dynamics of tumors in response to therapy thus optimizing the treatment approach and adding new insight into the antitumor mechanism of the combination approach.
Timeline
- Start
- 2026-03-13
- Primary completion
- 2027-09
- Completion
- 2028-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Simvastatin | Small molecule | 40 mg | Oral |
| Background | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Background | Capecitabine | Small molecule | 1250 mg/m2 | Oral |
| Background | Lederfolin | Unknown | 200 mg/m2 | — |
| Background | Nivolumab | Monoclonal antibody | 240 mg | Intravenous |
| Background | Nivolumab | Monoclonal antibody | 360 mg | Intravenous |
| Background | Oxaliplatin | Small molecule | 85 mg/m2 | — |
| Background | Oxaliplatin | Small molecule | 130 mg/m2 | — |
| Background | fluorouracil | Small molecule | 400 mg/m2 | — |
| Background | fluorouracil | Small molecule | 2400 mg/m2 | — |