NCT05230771Not yet recruitingPhase 3
Clinical Outcome of Palliative Surgery After Translational Therapy Versus Maintenance Chemotherapy for Metastatic Gastric Cancer: a Single Center Randomized Controlled Trial
Fujian Medical University0 sites120 target enrollmentStarted: April 1, 2022Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 120
- Primary Endpoint
- 2-year overall survival rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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):
- •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
Arms & Interventions
Chemotherapy alone
Active Comparator
After randomization, patients received chemotherapy alone
Intervention: Chemotheraoy along (Drug)
Palliative surgery after translational therapy
Experimental
After randomization, patients received palliative surgery after translational therapy
Intervention: Palliative surgery after translational therapy (Combination Product)
Outcomes
Primary Outcomes
2-year overall survival rate
Time Frame: 2 year
Survival rate of patients in the group from the date of enrollment to 2 years after enrollment
Secondary Outcomes
No secondary outcomes reported
Investigators
Chang-Ming Huang, Prof.
chief physician
Fujian Medical University
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