Actively Recruiting
Simvastatin Efficacy in ARID1A Mutated Advanced gastroESophageal Carcinoma Treated With Immunotherapy
Led by National Cancer Institute, Naples · Updated on 2026-04-14
84
Participants Needed
1
Research Sites
111 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Simvastatin Efficacy in ARID1A Mutated Advanced gastroESophageal Carcinoma Treated With Immunotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent for study and correlative procedures
- Age 18 years or older
- Histologically confirmed gastrooesophageal carcinoma
- Diagnosed with advanced, inoperable, or metastatic disease
- Tumors must be HER2 negative and ARID1A mutated
- Available tumor tissue sample
- No prior treatment for advanced gastrooesophageal carcinoma (except surgery before treatment)
- Eligible for standard nivolumab and oxaliplatin-based chemotherapy with combined positive score ≥ 5
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Measurable disease by RECIST 1.1 criteria on imaging
- Life expectancy over 12 weeks
- Adequate bone marrow function (ANC ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L, hemoglobin ≥ 9 g/dL)
- Adequate liver function (bilirubin ≤ 1.5 x ULN or ≤ 2 with biliary stent; AST/ALT ≤ 5 x ULN)
- Adequate kidney function (creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 60 mL/min males, ≥ 50 mL/min females)
- Known dihydropyrimidine dehydrogenase (DPYD) activity
You will not qualify if you...
- Prior malignancy within 5 years except treated skin basal or squamous cell carcinoma or in situ cervical cancer
- Prior chemotherapy or medical treatment for advanced gastrooesophageal carcinoma (adjuvant chemotherapy allowed if completed >12 months ago)
- Contraindications to nivolumab, simvastatin, or oxaliplatin-based chemotherapy
- Current treatment with statins, fibrates, or other cholesterol-lowering medications
- Major surgery within 4 weeks prior to enrollment
- Pregnancy or breastfeeding
- Presence of brain metastases
- Severe or uncontrolled systemic disease or other conditions affecting study participation or results
- History of poor cooperation or inability to understand consent
- Participation in another interventional drug or device study within 30 days before starting treatment
- Sexually active males or females of childbearing potential not willing to use contraception during and 6 months after study
- Hypersensitivity to simvastatin
- Acute or chronic hepatitis
- Personal or family history of severe liver disease
- Known coagulation disorders
AI-Screening
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Trial Site Locations
Total: 1 location
1
Istituto Nazionale Tumori Fondazione G. Pascale
Naples, Italia, Italy, 80131
Actively Recruiting
Research Team
A
Antonio Avallone, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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