Clinical trial NCT05230771: Clinical Outcome of Palliative Surgery After Translational Therapy for Metastatic Gastric Cancer Versus Maintenance Chemotherapy for Metastatic Gastric Cancer
Official title: Clinical Outcome of Palliative Surgery After Translational Therapy Versus Maintenance Chemotherapy for Metastatic Gastric Cancer: a Single Center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Metastatic Gastric Cancer
Surgery
Chemotherapy
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2022-02-09
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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):
  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：

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  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

Primary outcomes:
measure: 2-year overall survival rate
timeFrame: 2 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: