Status:
NOT_YET_RECRUITING
Clinical Outcome of Palliative Surgery After Translational Therapy for Metastatic Gastric Cancer Versus Maintenance Chemotherapy for Metastatic Gastric Cancer
Lead Sponsor:
Fujian Medical University
Conditions:
Metastatic Gastric Cancer
Surgery
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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：
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- 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
- 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
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05230771
Start Date
April 1 2022
End Date
March 1 2027
Last Update
April 1 2022
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