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

NCT06432205 | Recruiting

• 1 other identifier: 2023YJZ66
• Study Type: observational
• Target: 121
• Locations: 1 country
• Sites: 1

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?

Conditions

Gastric Cancer

Keywords

multi-disciplinary Team; shared-decision making; surgery

Outcome Measures

Primary Outcomes (1)

• overall survival

  From diagnosis of metastatic gastric cancer to any cause of death，assessed up to 5 years

Secondary Outcomes (2)

• 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

  after surgery, assessed up to 24 weeks

Study Arms (2)

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

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.

Interventions

surgery PROCEDURE

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

surgery group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patient in Beijing Cancer Hospital

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Xiaotian Zhang, professor

CONTACT

010-88196561; zhangxiaotianmed@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 29, 2024
• Study Start: November 9, 2023
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: May 29, 2024

Record last verified: 2024-02

Locations

CN (1)