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

NCT05230771 | Not Yet Recruiting Phase 3

• 1 other identifier: FUGES-24
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Metastatic Gastric Cancer; Surgery; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• 2-year overall survival rate

  Survival rate of patients in the group from the date of enrollment to 2 years after enrollment

  2 year

Study Arms (2)

Palliative surgery after translational therapy

EXPERIMENTAL

After randomization, patients received palliative surgery after translational therapy

Combination Product: Palliative surgery after translational therapy

Chemotherapy alone

ACTIVE COMPARATOR

After randomization, patients received chemotherapy alone

Drug: Chemotheraoy along

Interventions

Palliative surgery after translational therapy COMBINATION_PRODUCT

A total, distal, or proximal gastrectomy with D1 lymph node dissection was done depending on tumour after translational therapy . location.

Palliative surgery after translational therapy

Chemotheraoy along DRUG

Patients receive only the prescribed chemotherapy.

Chemotherapy alone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fujian Medical University: lead

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: December 5, 2021
• First Posted: February 9, 2022
• Study Start: April 1, 2022
• Primary Completion: March 1, 2024
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 1, 2022

Record last verified: 2022-03