The Effect of MDT Plus SDM on Survival Benefit of Advanced Gastric Cancer

The Effect of Multi-Disciplinary Team Plus Shared-Decision Making on Survival Benefit of Advanced Gastric Cancer - a Single Center, Non-randomized, Prospective, Controlled Study

The goal of this observational study is to learn about the long-term effect of surgery in metastatic gastric cancer patients who are accessed as having opportunity for surgery under Multi-disciplinary Team (MDT) evaluation. The main question it aims to answer is:

Does surgery extend survival time in metastatic gastric cancer patients who are accessed as having opportunity for surgery under Multi-disciplinary Team (MDT) evaluation?

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer
• Intervention / Treatment: Procedure: surgery

Detailed Description

Select metastatic gastric cancer patients that have the opportunity to undergo any forms of surgery through MDT. Then further evaluate these patients' risks and benefits. Let patients make their finally decision through shared-decision making (SDM). According to the actual decision, the patients are divided into surgery group and non-surgery group.

• Study Type: Observational
• Enrollment (Estimated): 121

Contacts and Locations

• Study Contact: Name: Xiaotian Zhang, professor; Phone Number: 010-88196561; Email: zhangxiaotianmed@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Recruiting
      • Beijing Cancer Hospital
      • Contact: Xiaotian Zhang, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patient in Beijing Cancer Hospital

Description

Inclusion Criteria:

• Age ≥18 years old;
• Participate in the formal MDT discussion and evaluate feasible surgical treatment;
• Gastric adenocarcinoma or gastroesophageal junction adenocarcinoma confirmed by histology;
• Immunotherapy must be received during the treatment;
• At least 1 distant metastatic organs, and the number of metastases is ≥1;
• The subject line blood routine (within 7 days) and biochemical indicators (within 14 days) meet the following standards:

hemoglobin≥90g/L； absolute count of neutral granulocytes (ANC) ≥1.5×10^9/L； platelets≥100×10^9/L； Alt, AST≤ 2.5 times the normal upper limit，≤5 times the normal upper limit value (with liver metastasis)； ALP ≤ 2.5 times the normal upper limit，≤5 times the normal upper limit (with liver or bone metastasis)； total bilirubin<1.5 times the normal upper limit value of serum； serum creatinine<1.5 times normal upper limit； albumin≥30g/L；

• ECOG 0 ～ 1 point;
• The expected life span is ≥3 months;
• Cardiopulmonary function is basically normal;
• Women and spouses of childbearing age are willing to adopt effective contraceptive methods.

Exclusion Criteria:

• Those who do not meet the above selected standards or have chemotherapy contraindications;
• Combined with other primary malignant tumors;
• Pregnancy, lactating women or women of childbearing age and spouses refuse to adopt effective contraceptive methods;
• History of organ transplantation (including bone marrow autologous transplantation and peripheral stem cell transplantation);
• History of long -term treatment of steroids (Note: Short -term users discontinue drugs> 2 weeks can be selected);
• History of peripheral nervous system disorders or obvious mental disorders and central nervous system disorders;
• Accompanied by severe infection;
• Accompanied by swallowing difficulties, complete or incomplete digestive tract obstruction, gastrointestinal bleeding, perforation, etc.;
• Severe liver disease (such as liver cirrhosis, etc.), kidney disease, respiratory disease, or chronic system diseases such as diabetes, hypertension, high blood pressure;
• Coronary heart disease with obvious clinical symptoms, such as: congestive heart failure, obvious symptoms, cardiac disorders, hypertension, or myocardial infarction seizures, or inadequate heart function within 6 months;
• Persons without legal capacity, medical or ethical reasons affecting the continuation of research.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
surgery group; metastatic gastric cancer patients who are assessed as having the opportunity for surgery finally choose to undergo surgery after MDT plus SDM.	Procedure: surgery; any forms of surgery, such as all tumor resection, partial tumor resection and palliative tumor resection surgery
non-surgery group; metastatic gastric cancer patients who are assessed as having the opportunity for surgery finally choose not to undergo surgery after MDT plus SDM.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
overall survival	From diagnosis of metastatic gastric cancer to any cause of death，assessed up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
progression free survival		From diagnosis of metastatic gastric cancer to tumor progression or any cause of death, assessed up to 2 years
safety of surgery	any grade of adverse event	after surgery, assessed up to 24 weeks

Collaborators and Investigators

• Sponsor: Peking University

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2023
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: May 15, 2024
• First Submitted That Met QC Criteria: May 22, 2024
• First Posted (Actual): May 29, 2024

Study Record Updates

• Last Update Posted (Actual): May 29, 2024
• Last Update Submitted That Met QC Criteria: May 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: shared-decision making; surgery; multi-disciplinary Team
• 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: 2023YJZ66

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No