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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05230771
• Other study ID #: FUGES-24
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: April 1, 2022
• Est. completion date: March 1, 2027

Study information

• Verified date: March 2022
• Source: Fujian Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: March 1, 2027
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy
• Metastatic Gastric Cancer
• Stomach Neoplasms
• Surgery

Intervention

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.

Drug:
• Chemotheraoy along
Patients receive only the prescribed chemotherapy.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-year overall survival rate	Survival rate of patients in the group from the date of enrollment to 2 years after enrollment	2 year