Evaluating the impact of surgery on survival in advanced gastric cancer patients

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

This study is testing if surgery can help people with advanced stomach cancer live longer compared to those who don't have surgery.

Quick facts

• Study type: Observational
• Enrollment: 121 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Peking University (Academic / other)
• Drugs / interventions: chemotherapy, Immunotherapy
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT06432205 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the long-term effects of surgical intervention in patients with metastatic gastric cancer who are deemed suitable for surgery by a multi-disciplinary team (MDT). Patients will undergo a thorough evaluation of their risks and benefits before making a decision through shared-decision making (SDM). Based on their choices, participants will be categorized into surgery and non-surgery groups to analyze survival outcomes. The study focuses on understanding whether surgical treatment can extend survival time in this patient population.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma who are eligible for surgical evaluation.

Not a fit: Patients who are not eligible for surgery or have a poor prognosis with an expected lifespan of less than three months may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide critical insights into the survival benefits of surgical intervention for patients with advanced gastric cancer.

How similar studies have performed: While there have been studies on surgical interventions in gastric cancer, this specific approach involving MDT evaluation and SDM is relatively novel.

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.

Where this trial is running

Beijing, Beijing

• Beijing Cancer Hospital — Beijing, Beijing, China (Recruiting)

Study contacts

• Study coordinator: Xiaotian Zhang, professor

Conditions Gastric Cancer; multi-disciplinary Team; shared-decision making; surgery