Clinical Outcome of Palliative Surgery After Translational Therapy for Metastatic Gastric Cancer Versus Maintenance Chemotherapy for Metastatic Gastric Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Palliative surgery after translational therapy, Chemotheraoy along.
- Who it may be relevant to
- Registry conditions: Metastatic Gastric Cancer, Surgery, Chemotherapy. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical Outcome of Palliative Surgery After Translational Therapy Versus Maintenance Chemotherapy for Metastatic Gastric Cancer: a Single Center Randomized Controlled Trial
Overview
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 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. - Drug Chemotheraoy along
Patients receive only the prescribed chemotherapy.
Primary outcome measures
- 2-year overall survival rate [Time frame: 2 year]
Eligibility criteria
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):
- HB≥100g/L，
- WBC≥3×109/L
- ANC≥1.5×109/L，
- PLT≥100×109/L； （2）Biochemical tests must meet the following criteria：
<!-- -->
- BIL <1.5×upper limit of normal (ULN)，
- ALT and AST<2.5ULN，GPT≤1.5×ULN；
- 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:
- NYHA class II or more serious heart failure
- unstable angina pectoris
- myocardial infarction within 1 year
- clinically significant ventricular or ventricular arrhythmias that were poorly controlled without or despite clinical intervention
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT05230771 · FUGES-24