HER2-negative advanced unresectable or recurrent metastatic gastric cancer
Conditions
Interventions
Oral chemotherapy group:Oral Paclitaxel Combined with S-1
Sponsors
Affiliated Hospital of North Sichuan Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1.Subjects must meet ALL of the following criteria to be eligible for this study: (1)Fully understand this study and voluntarily sign the Informed Consent Form (ICF); (2)Age >=18 years and =1 measurable lesion (according to RECIST 1.1 criteria; Note: Lesions previously treated with radiotherapy cannot be considered target lesions unless there is clear progression post-radiotherapy); (5)Within 1 week prior to the first dose of study medication, must have adequate hematological, hepatic, and renal function, defined as follows:Hematology (without transfusion, granulocyte colony-stimulating factor (G-CSF) use, or corrective medication within 10 days prior to testing): Absolute neutrophil count (ANC) >=1.5×10^9/L, platelets >=100×10^9/L, and hemoglobin >=90 g/L.Liver Function: Serum total bilirubin =12 weeks; (9)Women of childbearing potential must have a negative serum pregnancy test within 1 week prior to enrollment. Men and women of childbearing potential must agree to use effective contraception throughout the study and for 3 months after the last dose of study medication.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: Subjects meeting ANY of the following criteria will be excluded from this study: (1)History of any other malignancy within 5 years prior to the first dose of study medication (except for radically resected basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix, breast, etc.); (2)Gastrointestinal dysfunction or other conditions that may affect the absorption of the study drug within 6 months prior to the first dose (e.g., severe ulcers, uncontrollable nausea, vomiting, diarrhea, malabsorption syndrome, etc.; except gastrectomy); (3)Major hemorrhagic or ischemic events within 6 months prior to the first dose (including hemoptysis, severe gastrointestinal bleeding, hematemesis, central nervous system bleeding, severe epistaxis or vaginal bleeding, cerebral infarction, transient ischemic attack, etc.); (4)History of alcohol or drug dependence or psychiatric disorders within 3 months prior to the start of study treatment; (5)Requiring enteral nutrition (e.g., nasogastric tube, gastrojejunal tube, gastrostomy, jejunostomy, etc.) within 4 weeks prior to the first dose; (6)Major surgical procedure (excluding diagnostic biopsy) within 4 weeks prior to the first dose; (7)Toxicities from prior anti-tumor therapy have not recovered to =2), or other severe cardiac disease within 6 months prior to the first dose; or clinically significant abnormalities on electrocardiogram (ECG) [e.g., arrhythmia, heart rate-corrected QT (QTc) interval >450 ms]; or left ventricular ejection fraction 140 mmHg, diastolic blood pressure >90 mmHg) despite combination therapy with >=2 antihypertensive agents; (9)Prior use of taxane-based drugs within 12 months prior to the first dose;; (10)Use of immunosuppressants or long-term corticosteroids (dose >10 mg/day prednisone or equivalent) within 2 weeks prior to the first dose. Note: Corticosteroids for prophylaxis of intravenous contrast allergy are permitted; (11)Squamous cell or undifferentiated gastric cancer; (12)Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with stable brain metastases may participate (i.e., no evidence of progression on repeat imaging for at least 4 weeks prior to the first dose and no clinical symptoms due to brain metastases, including but not limited to: headache, dizziness, ataxia, hemiplegia, epilepsy, mental disorders, etc.); (13)Investigator's judgment of existing or suspected bile secretion problems; (14)Requirement for long-term use of proton pump inhibitors or H2 receptor antagonists during the trial; Use of strong inducers or inhibitors of cytochrome P450 (CYP) 3A4 or CYP2C8 within 2 weeks prior to the first dose (see Section 4.3 of the protocol for details); (15)Known allergy to the study drug oral paclitaxel solution or any of its components, or to the comparator drug paclitaxel injection; (16)Presence of any of the following: Active infection that the investigator believes may affect the subject's participation or study outcomes; Positive hepatitis B surface antigen (HBsAg) with HBV DNA copy number > normal detection lim
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free-Survival;Overall Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease Control Rate;Safety; | — |
Countries
China
Contacts
Public ContactQijun Lv
Affiliated Hospital of North Sichuan Medical College
Outcome results
None listed