Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 to 75

Combination therapy for advanced gastric cancer

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

Run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · NCT06371586 · Data updated 2026-11-12

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

PhasePhase 2
Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment67 (estimated)
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
Academic / other
Drugs / interventionschemotherapy, Bevacizumab, radiation
Locations1 site (Beijing)
StatusRecruiting
StartedMarch 1, 2024
Main results expectedMarch 1, 2027
Study endsMarch 1, 2027
Registry record updatedApril 17, 2024
Trial IDNCT06371586 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably not a fit

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

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

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

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.