Clinical Outcome of Palliative Surgery After Translational Therapy for Metastatic Gastric Cancer Versus Maintenance Chemotherapy for Metastatic Gastric Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Palliative surgery after translational therapy After randomization, patients received palliative surgery after translational therapy |
Combination Product: Palliative surgery after translational therapy
A total, distal, or proximal gastrectomy with D1 lymph node dissection was done depending on tumour after translational therapy .
location.
|
| Active Comparator: Chemotherapy alone After randomization, patients received chemotherapy alone |
Drug: Chemotheraoy along
Patients receive only the prescribed chemotherapy.
|
Outcome Measures
Primary Outcome Measures
- 2-year overall survival rate [2 year]
Survival rate of patients in the group from the date of enrollment to 2 years after enrollment
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age from 18 to 75 years
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Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically
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CT/MRI, PET-CT, or laparoscopic exploration should be performed before surgery to confirm the diagnosis of distant metastasis
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Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
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Estimated survival time was over 3 months
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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):
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HB≥100g/L，
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WBC≥3×109/L
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ANC≥1.5×109/L，
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PLT≥100×109/L； （2）Biochemical tests must meet the following criteria：
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BIL <1.5×upper limit of normal (ULN)，
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ALT and AST<2.5ULN，GPT≤1.5×ULN；
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Cr≤1ULN，Ccr >60ml/min
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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
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Did not participate in other clinical studies before and during treatment
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Subjects voluntarily joined the study and signed informed consent with good compliance and follow-up
Exclusion Criteria:
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History of other malignant disease within past five years
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History of immunodeficiency, including HIV positive, or other acquired congenital immunodeficiency disease, or a history of organ transplantation and allogeneic bone marrow transplantation
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Accompanied by serious heart, lung, liver and kidney diseases, neuropsychiatric disorders, jaundice or associated severe infection
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Women during pregnancy or breast-feeding
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Subjects had poorly controlled cardiovascular clinical symptoms or diseases, including but not limited to:
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NYHA class II or more serious heart failure
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unstable angina pectoris
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myocardial infarction within 1 year
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clinically significant ventricular or ventricular arrhythmias that were poorly controlled without or despite clinical intervention
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Fujian Medical University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FUGES-24