Cisplatin Combined with Oral TS-1 in Patients with Advanced Solid Tumors with Different Degrees of Liver Dysfunction

Inclusion Criteria:

Patients must fulfill ALL the following inclusion criteria

* Age 18 years.
* Histologic or cytologic diagnosis of carcinoma, that is either refractory to standard therapy or has no available therapies.
* Measurable disease using the RECIST v1.1 criteria
* ECOG performance 0 or 1.
* Estimated life expectancy of at least 12 weeks.
* Adequate bone marrow and renal function as follows:

Bone marrow: Absolute neutrophil count (ANC) 1.5 x 109/L Platelets 100 x 109/L Renal: calculated creatinine clearance \>60ml/minute Total bilirubin and AST/ALT as described in Table 1

* Able to swallow pills
* Signed informed consent from patient or legal representative
* Patients with reproductive potential must use an approved contraceptive method if appropriate (e.g., intrauterine device, birth control pills, or barrier device) during and for three months after the study.
* Females with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment.

Exclusion Criteria:

Patients will be excluded from the study for any of the following reasons:

* Concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.
* Treatment of a small molecule targeted agents ≤ 2 weeks prior to starting study treatment
* Treatment within the last 30 days with any investigational drug.
* Radiotherapy ≤4 weeks prior to starting study treatment or who have not recovered from radiotherapy-related toxicities. Limited field palliative radiotherapy ≤ 2 weeks prior to starting study treatment is allowed
* Major surgery within 28 days of study drug administration.
* History or presence of serious uncontrolled ventricular arrhythmias
* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of TS-1 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
* Known history of human immunodeficiency virus (HIV) seropositivity (HIV testing is not mandatory)
* Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy.
* Pregnancy.
* Breast feeding.
* Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.
* Poorly controlled diabetes mellitus.
* Second primary malignancy that is clinically detectable at the time of consideration for study enrollment
* Symptomatic brain metastasis.
* History of significant neurological or mental disorder, including seizures or dementia.