Chemotherapy, Metastatic Gastric Cancer, Surgery
Conditions
Brief summary
This single-center, prospective study was conducted to investigate the efficacy and safety of palliative surgery after translational therapy in the treatment of metastatic gastric cancer. The primary endpoint was 2-year overall survival (OS) rate. Secondary endpoints were median OS, progression-free survival (PFS), 1-year OS, adverse events (AE), severe AE, the quality of life (QOL) and treatment cost.
Interventions
COMBINATION_PRODUCTPalliative surgery after translational therapy
A total, distal, or proximal gastrectomy with D1 lymph node dissection was done depending on tumour after translational therapy . location.
DRUGChemotheraoy along
Patients receive only the prescribed chemotherapy.
Sponsors
Fujian Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age from 18 to 75 years * Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically * CT/MRI, PET-CT, or laparoscopic exploration should be performed before surgery to confirm the diagnosis of distant metastasis * Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG) * Estimated survival time was over 3 months * The major organs are functioning normally and meet the following criteria: (1) Blood routine examination should meet the requirements (no blood transfusion within 14 days): 1. HB≥100g/L， 2. WBC≥3×109/L 3. ANC≥1.5×109/L， 4. PLT≥100×109/L； （2）Biochemical tests must meet the following criteria： <!-- --> 1. BIL \<1.5×upper limit of normal (ULN)， 2. ALT and AST\<2.5ULN，GPT≤1.5×ULN； 3. Cr≤1ULN，Ccr \>60ml/min * Fertile women must have taken a pregnancy test (serum) within 7 days prior to enrollment with negative results and be willing to use an appropriate method of contraception during the trial period and 8 weeks after the last trial drug; For men, they should be surgically sterilized or agree to use the appropriate method of contraception during the trial period and 8 weeks after the last administration of the trial drug * Did not participate in other clinical studies before and during treatment * Subjects voluntarily joined the study and signed informed consent with good compliance and follow-up
Exclusion criteria
* History of other malignant disease within past five years * History of immunodeficiency, including HIV positive, or other acquired congenital immunodeficiency disease, or a history of organ transplantation and allogeneic bone marrow transplantation * Accompanied by serious heart, lung, liver and kidney diseases, neuropsychiatric disorders, jaundice or associated severe infection * Women during pregnancy or breast-feeding * Subjects had poorly controlled cardiovascular clinical symptoms or diseases, including but not limited to: 1. NYHA class II or more serious heart failure 2. unstable angina pectoris 3. myocardial infarction within 1 year 4. clinically significant ventricular or ventricular arrhythmias that were poorly controlled without or despite clinical intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2-year overall survival rate | 2 year | Survival rate of patients in the group from the date of enrollment to 2 years after enrollment |
Outcome results
None listed