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Oxaliplatin

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Standard of care oxaliplatin-based chemotherapy

(400 mg tablet): 2 tablets taken orally AM and 1 tablet PM daily (total 1,200 mg daily) prior to surgical resection

S-adenosylmethionine (SAMe) supplement

Surgery

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Alexandra Gangi, MD

Jun Gong, MD

Andrew Hendifar, MD

Arsen Osipov, MD

Maha Guindi, MD

Jeremy Lorber, MD

Kevin S. Scher, MD

This is an open-label, phase II study that may provide evidence that taking S-adenosylmethionine (SAMe) supplementation prevents oxaliplatin, a type of chemotherapy drug, associated liver toxicity in patients with resectable colorectal liver metastases. Resectable means that it is able to removed with surgery. Patients will take two SAMe tablets in the morning and one tablet in the evening for 3-6 months (about 6-8 cycles of chemotherapy) in addition to oxaliplatin based chemotherapy followed by surgical removal of the colorectal liver metastases.

SAMe in Prevention of Oxaliplatin-associated Liver Injury

A Phase II, Open-Label Trial of S-Adenosylmethionine (SAMe) in Prevention of Oxaliplatin Associated Liver Injury

To identify the effect of SAMe in preventing oxaliplatin associated liver injury as determined by lack of injury on histopathologic analysis in patients with liver only stage IV colorectal cancer. Improvement in liver injury will be measured by the degree/histopathologic grade of liver injury utilizing the Combined Vascular Injury (CVI) Score in non-cancerous liver tissue post therapy compared to historical controls. CVI score will evaluate and grade sinusoidal dilation, small vessel loss/obliteration, focal hepatocyte plate disruption, parenchymal extinction lesions, nodular regenerative hyperplasia, peliosis, and veno-occlusive like changes. Rate of sinusoidal obstruction syndrome (SOS), as measured by CVI Score, ranging from 0-13. A CVI score of 3 or more indicates SOS. Compared to historical controls.

To evaluate the efficacy of SAMe during oxaliplatin based therapy in stage IV liver-only colorectal cancer, Objective Response Rate (ORR) will be measured by the proportion of patients with confirmed complete response (CR) or partial response (PR) per RECIST 1.1. ORR will be assessed from screening until EOT.

Calculate surgical EBL in all patients undergoing resection

Length of hospital stay (LOS) to historical controls, the following will be conducted:

ii. Calculate hospital LOS in all patients undergoing resection iii. Account for 30-day readmission

Incidence of oxaliplatin treatment delays will be evaluated by recording the following: If treatment delay occurred and time point/duration of treatment delay

Incidence of oxaliplatin dose reduction will be evaluated by recording the following: If dose reduction occurred and time point of occurrence

Safety and tolerability of the combination will be evaluated by determining the proportion of patients with treatment-related adverse events of all grades as graded per CTCAE v.5, from first dose of study drug until 30 days post last dose of study drug.

Jarrow Formulas Inc

Cedars-Sinai Medical Center

Sponsor-Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
SAMe in Prevention of Oxaliplatin-associated Liver Injury	NCT06258525	Colorectal Canc... Liver Metastase... Liver Metastasi... Liver Injury Sinusoidal Obst... 5-Fluorouracil ... Liver Toxicity,...	Standard of car... S-adenosylmethi... Surgery	18 Years -	Cedars-Sinai Medical Center
SAMe in Prevention of Oxaliplatin-associated Liver Injury	NCT06258525	Colorectal Canc... Liver Metastase... Liver Metastasi... Liver Injury Sinusoidal Obst... 5-Fluorouracil ... Liver Toxicity,...	Standard of car... S-adenosylmethi... Surgery	18 Years -	Cedars-Sinai Medical Center

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