Combination therapy for advanced gastric cancer

Neo-Sequence 2：Phase 2 Study of Neoadjuvant Chemotherapy Plus Anti-angiogenesis Therapy and Immunotherapy for Locally Advanced Diffuse Gastric Cancer

This study is testing a new combination of treatments for people with advanced gastric cancer to see if it can help them respond better before surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 67 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Academic / other)
• Drugs / interventions: chemotherapy, Bevacizumab, radiation
• Locations: 1 site (Beijing)
• Trial ID: NCT06371586 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates a neoadjuvant treatment regimen for locally advanced diffuse gastric cancer, combining Albumin paclitaxel, SOX, and Bevacizumab with PD-1 monoclonal antibody therapy. The treatment lasts for six cycles, with assessments through CT scans and gastroscopy to monitor therapeutic effects. Patients showing positive responses may proceed to surgery, while others may continue with additional cycles of the regimen or switch to alternative treatments based on their response. The study aims to improve outcomes for patients with this aggressive cancer type.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with locally advanced diffuse or mixed type gastric cancer who have not received prior anti-tumor treatments.

Not a fit: Patients with gastrointestinal obstruction, recurrent bleeding, or those with immunodeficiency or active autoimmune diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance treatment efficacy and improve surgical outcomes for patients with advanced gastric cancer.

How similar studies have performed: Previous studies have shown promise with similar combination therapies in treating advanced gastric cancer, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Local advanced diffuse or mixed type gastric cancer detected by pathology and endoscopy;
2. Chest, abdomen, and pelvis enhanced CT, neck and supraclavicular ultrasound, gastroscopy, and endoscopic ultrasound were used to diagnose T3-4NanyM0 gastric cancer or gastroesophageal junction cancer (refer to AJCC staging, 8th edition);
3. Has not received any anti-tumor treatment for gastric cancer yet;
4. Age range from 18 to 75 years old;
5. ECOG score 0-1 points;
6. Liver and kidney function and blood routine meet the following conditions:

   Neutrophils\>1.5G/L, Hb\>90g/L, PLT\>100G/L; ALT and AST\<2.5ULN; TBIL\<1.5 ULN; Cr\<1.0ULN;
7. Left ventricular ejection fraction\>60%;
8. Good compliance and ability to accept long-term follow-up;
9. Sign informed consent.

Exclusion Criteria:

1. Gastrointestinal obstruction or recurrent bleeding cannot be controlled;
2. Those who cannot swallow pills;
3. Diagnose immunodeficiency or active autoimmune diseases, have received or are currently receiving immunomodulators, systemic steroid therapy, or immunosuppressive drugs within the past two years;
4. Interstitial pneumonia;
5. Moderate to severe cirrhosis caused by any reason;
6. Uncontrollable hypertension, severe kidney disease, and significant cardiovascular and cerebrovascular diseases;
7. Active infections that require systemic treatment;
8. Previously suffered from other tumors, excluding cured skin cancer and cervical cancer in situ;
9. Internal medicine diseases that do not meet the chemotherapy criteria at the same time;
10. Pregnant and lactating patients;
11. Individuals with a history of mental illness and poor compliance.

Where this trial is running

Beijing

• Cancer hospital，Chinese acadamy of medical sciences — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Chunxia Du, MD

Conditions Gastric Cancer; Diffuse Type Carcinoma