Phase I Study of Sorafenib with FOLFOX4 as First-Line Treatment for Advanced or Metastatic Stomach Cancer

Inclusion Criteria

• Must be over 18 years old.
• Have a confirmed diagnosis of stomach cancer through lab tests.
• Have newly diagnosed or returning advanced stomach cancer that cannot be removed by surgery.
• Have not received any previous chemotherapy or radiation therapy.
• Have at least one tumor that can be measured by scans.
• Be in good overall health with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Have an expected survival time of at least 3 months.
• Be willing to provide informed consent to participate in the study.

Exclusion Criteria

• Have a history of other cancers, except for cured non-melanoma skin cancer or cervical cancer in situ.
• Have had surgery, a major biopsy, or significant injury within 28 days before joining the study.
• Have cancer spread to the lining of the abdomen or bowel obstruction.
• Have severe bleeding in the digestive tract.
• Have nerve damage of grade 1 or higher.
• Have a history of serious neurological or mental health conditions.
• Be pregnant or breastfeeding.
• Women of childbearing age not willing to use effective birth control.
• Have a history of serious heart conditions, such as severe heart failure, unstable heart disease, or uncontrolled high blood pressure.
• Have a severe active infection.
• Have epilepsy requiring medication.
• Have received immunotherapy or certain chemotherapy drugs within 4 weeks before the study.
• Have allergies to the study drugs or other medications used in the study.
• Have any safety or compliance issues that could affect participation.
• Be unable to swallow pills.