## Protocol Section
### Identification Module
**NCT ID:** NCT06432205

**Brief Title:** The Effect of MDT Plus SDM on Survival Benefit of Advanced Gastric Cancer

**Official Title:** 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

#### Organization Study ID Info
**ID:** 2023YJZ66
#### Organization
**Class:** OTHER
**Full Name:** Peking University
### Status Module
#### Completion Date
**Date:** 2025-08

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-08

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-11-09

**Type:** ACTUAL

**Status Verified Date:** 2024-02

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Peking University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** 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?

**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.

### Conditions Module

**Conditions:**

- Gastric Cancer

**Keywords:**

- multi-disciplinary Team

- shared-decision making

- surgery

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 121

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** metastatic gastric cancer patients who are assessed as having the opportunity for surgery finally choose to undergo surgery after MDT plus SDM.

**Intervention Names:**

- Procedure: surgery

**Label:** surgery group

#### Arm Group 2

**Description:** metastatic gastric cancer patients who are assessed as having the opportunity for surgery finally choose not to undergo surgery after MDT plus SDM.

**Label:** non-surgery group

### Interventions

#### Intervention 1

**Arm Group Labels:**

- surgery group

**Description:** any forms of surgery, such as all tumor resection, partial tumor resection and palliative tumor resection surgery

**Name:** surgery

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Measure:** overall survival

**Time Frame:** From diagnosis of metastatic gastric cancer to any cause of death，assessed up to 5 years

#### Secondary Outcomes

**Measure:** progression free survival

**Time Frame:** From diagnosis of metastatic gastric cancer to tumor progression or any cause of death, assessed up to 2 years

**Description:** any grade of adverse event

**Measure:** safety of surgery

**Time Frame:** after surgery, assessed up to 24 weeks

### Eligibility Module

**Eligibility Criteria:** 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.

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** patient in Beijing Cancer Hospital

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** zhangxiaotianmed@163.com

**Name:** Xiaotian Zhang, professor

**Phone:** 010-88196561

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Beijing

**Contacts:**

***Contact 1:***

- **Name:** Xiaotian Zhang, Professor

- **Role:** CONTACT

**Country:** China

**Facility:** Beijing Cancer Hospital

**State:** Beijing

**Status:** RECRUITING

**Zip:** 100142

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005770

- Term: Gastrointestinal Neoplasms

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000013272

- Term: Stomach Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M16064

- Name: Stomach Neoplasms

- Relevance: HIGH

- As Found: Gastric Cancer

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16062

- Name: Stomach Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T5486

- Name: Stomach Cancer

- Relevance: HIGH

- As Found: Gastric Cancer

### Condition Browse Module - Meshes

- ID: D000013274

- Term: Stomach Neoplasms

### Misc Info Module

- Version Holder: 2024-05-31
