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

NCT ID: NCT05230771

Last Updated: 2022-04-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2027-03-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Palliative surgery after translational therapy

After randomization, patients received palliative surgery after translational therapy

Group Type: EXPERIMENTAL

Palliative surgery after translational therapy

Intervention Type: COMBINATION_PRODUCT

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

location.

Chemotherapy alone

After randomization, patients received chemotherapy alone

Group Type: ACTIVE_COMPARATOR

Chemotheraoy along

Intervention Type: DRUG

Patients receive only the prescribed chemotherapy.

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

Chemotheraoy along

Patients receive only the prescribed chemotherapy.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Medical University

OTHER

Sponsor Role: lead

Responsible Party

Chang-Ming Huang, Prof.

chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

FUGES-24

Identifier Type: -

Identifier Source: org_study_id