Clinical Outcome of Palliative Surgery After Translational Therapy for Metastatic Gastric Cancer Versus Maintenance Chemotherapy for Metastatic Gastric Cancer

Clinical Outcome of Palliative Surgery After Translational Therapy Versus Maintenance Chemotherapy for Metastatic Gastric Cancer: a Single Center Randomized Controlled Trial

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 Overview

• Status: Not yet recruiting
• Conditions: Chemotherapy; Surgery; Metastatic Gastric Cancer
• Intervention / Treatment: Combination product: Palliative surgery after translational therapy; Drug: Chemotheraoy along

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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：
  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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2-year overall survival rate	Survival rate of patients in the group from the date of enrollment to 2 years after enrollment	2 year

Collaborators and Investigators

• Sponsor: Fujian Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2022
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): March 1, 2027

Study Registration Dates

• First Submitted: December 5, 2021
• First Submitted That Met QC Criteria: January 29, 2022
• First Posted (Actual): February 9, 2022

Study Record Updates

• Last Update Posted (Actual): April 1, 2022
• Last Update Submitted That Met QC Criteria: March 30, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: FUGES-24

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No