Locally Advanced Gastric Adenocarcinoma, Chemotherapy Effect
Conditions
Brief summary
The goal of this single arm clinical trial is to learn about sequential S-1 adjuvant therapy in patient wich locally advanced gastric cancer. The main question it aims to answer is: • The efficacy and safety of S-1 adjuvant therapy, following D2 radical surgery and DS(Docetaxel + S-1) adjuvant chemotherapy. All patients with locally advanced gastric cancer will received D2 radical surgery, 6 cycles of DS chemotherapy, and sequential S-1 chemotherapy up to 1 year postoperation.
Interventions
DRUGDocetaxel
Docetaxel 40mg/m2，every 21 days，6 cycles.
S-1 40-60mg/m2，p.o, BID, day 1-14, till 1 year postoperation.
Sponsors
Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* (1) Histologically or cytologically confirmed adenocarcinoma of the stomach or adenocarcinoma of the gastroesophageal junction; * (2) Radical surgery (D2 lymph node dissection) for gastric cancer in our center, with postoperative pathological stage of stage III; * (3) No significant tumor recurrence or metastasis as assessed by imaging; * (4) Age 18 years - 75 years; * (5) ECOG score of 0 or 1; * (6) Laboratory tests tolerant to chemotherapy; * (7) Hematological examination: no obvious signs of hematologic diseases, ANC ≥ 1.5 × 10\^9/L, platelet count ≥ 80 × 10\^9/L, Hb ≥ 90 g/L, WBC ≥ 3.0 × 10\^9/L before enrollment, and no bleeding tendency; (8) Biochemical examination: total bilirubin \< 1.5 times the upper limit of normal value, AST, ALT \< 2.5 times the upper limit of normal value, creatinine \< 1.5 times the upper limit of normal value.
Exclusion criteria
* (1) Other pathological types of tumors; * (2) Pregnant or nursing women; * (3) Those with a history of other malignant neoplastic disease in the last 5 years; * (4) Those with a history of uncontrolled epilepsy, central nervous system disease, or psychiatric disorder, where the investigator determines whether the clinical severity prevents signing an informed consent form or affects the patient's compliance with oral medications; * (5) Clinically severe (i.e., active) heart disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) class II or worse congestive heart failure or arrhythmias requiring pharmacologic intervention, or a history of myocardial infarction within the last 12 months; * (6) Severe diabetes-related complications, such as diabetic nephropathy, diabetic ketosis, etc; * (7) Those with digestive tract obstruction or physiological abnormalities, or suffering from malabsorption syndrome, which may affect S-1 absorption; * (8) Those who have had gastrointestinal bleeding in the last two weeks, or are at high risk of bleeding as judged by the investigator; * (9) Known to have peripheral nerve disease ≥ NCI-CTC AE grade 1. but with deep tendon reflexes (DTR) only; * (10) Those requiring immunosuppressive therapy for organ transplantation; * (11) who have received other chemotherapy regimens * (12) Those with uncontrolled severe infections, or other serious concomitant diseases; * (13) Allergic to S-1 or any of the study drug components.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence free survival | 3 years | Recurrence free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | up to 5 years | Overall survival |
Countries
China
Contacts
Primary ContactXiaoli Jin
Outcome results
None listed