Neo-Sequence 2：NCT Plus Anti-angiogenesis Therapy and Immunotherapy for LADGC

Last updated: April 14, 2024
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Overall Status: Active - Recruiting

Phase

2

Condition

Gastric Cancer

Digestive System Neoplasms

Stomach Cancer

Treatment

Albumin paclitaxel+SOX+BEV+ PD-1 monoclonal antibody therapy

Clinical Study ID

NCT06371586
NCC4537
  • Ages 18-75
  • All Genders

Study Summary

The regimen of Albumin paclitaxel+SOX+BEV neoadjuvant therapy lasted for 6 cycles, during which PD-1 monoclonal antibody therapy was interspersed for 4 cycles for locally advanced diffuse gastric cancer.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Local advanced diffuse or mixed type gastric cancer detected by pathology andendoscopy;
  2. Chest, abdomen, and pelvis enhanced CT, neck and supraclavicular ultrasound,gastroscopy, and endoscopic ultrasound were used to diagnose T3-4NanyM0 gastric canceror 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

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 arecurrently receiving immunomodulators, systemic steroid therapy, or immunosuppressivedrugs 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 andcerebrovascular diseases;
  7. Active infections that require systemic treatment;
  8. Previously suffered from other tumors, excluding cured skin cancer and cervical cancerin situ;
  9. Internal medicine diseases that do not meet the chemotherapy criteria at the sametime;
  10. Pregnant and lactating patients;
  11. Individuals with a history of mental illness and poor compliance.

Study Design

Total Participants: 67
Treatment Group(s): 1
Primary Treatment: Albumin paclitaxel+SOX+BEV+ PD-1 monoclonal antibody therapy
Phase: 2
Study Start date:
March 01, 2024
Estimated Completion Date:
March 01, 2027

Study Description

The biweekly regimen of Albumin paclitaxel+SOX+BEV neoadjuvant therapy lasted for 6 cycles, during which PD-1 monoclonal antibody therapy was interspersed for 4 cycles. Review CT and gastroscopy every 3 cycles to evaluate the therapeutic effect. Patients who have been evaluated as effective after 6 cycles of treatment may consider surgery; Or continue the dual cycle regimen ofAlbumin paclitaxel+Bevacizumab for 3 cycles, while PD-1 monoclonal antibody for 2 cycles. Afterwards, the therapeutic effect will be evaluated, and surgery, radiotherapy, or maintenance medication treatment will be determined based on the therapeutic effect. Surgical patients begin adjuvant treatment 1-2 months after surgery based on the curative and pathological results of the surgery. Those who fail to evaluate during neoadjuvant therapy will undergo surgery or radiation therapy, or switch to a second-line systemic treatment plan.

Connect with a study center

  • Cancer hospital，Chinese acadamy of medical sciences

    Beijing,
    China

    Active - Recruiting

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