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

Primary Purpose

Metastatic Gastric Cancer, Surgery, Chemotherapy

Status

Not yet recruiting

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Palliative surgery after translational therapy

Chemotheraoy along

About this trial

This is an interventional treatment trial for Metastatic Gastric Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Palliative surgery after translational therapy

Chemotherapy alone

Arm Description

After randomization, patients received palliative surgery after translational therapy

After randomization, patients received chemotherapy alone

Outcomes

Primary Outcome Measures

2-year overall survival rate

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05230771

First Posted

December 5, 2021

Last Updated

March 30, 2022

Sponsor

Fujian Medical University

1. Study Identification

Unique Protocol Identification Number

NCT05230771

Brief Title

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

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

April 1, 2022 (Anticipated)

Primary Completion Date

March 1, 2024 (Anticipated)

Study Completion Date

March 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fujian Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Gastric Cancer, Surgery, Chemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Palliative surgery after translational therapy

Arm Type

Experimental

Arm Description

After randomization, patients received palliative surgery after translational therapy

Arm Title

Chemotherapy alone

Arm Type

Active Comparator

Arm Description

After randomization, patients received chemotherapy alone

Intervention Type

Combination Product

Intervention Name(s)

Palliative surgery after translational therapy

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Chemotheraoy along

Intervention Description

Patients receive only the prescribed chemotherapy.

Primary Outcome Measure Information:

Title

2-year overall survival rate

Description

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

Time Frame

2 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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): HB≥100g/L， WBC≥3×109/L ANC≥1.5×109/L， PLT≥100×109/L；（2）Biochemical tests must meet the following criteria： BIL <1.5×upper limit of normal (ULN)， ALT and AST<2.5ULN，GPT≤1.5×ULN； 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: 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

12. IPD Sharing Statement

Learn more about this trial

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

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