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Recruiting NCT06371586

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

Phase II Interventional Gastric Cancer Diffuse Type Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Albumin paclitaxel+SOX+BEV+ PD-1 monoclonal antibody therapy.
Who it may be relevant to
Registry conditions: Gastric Cancer, Diffuse Type Carcinoma. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed 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.

Interventions

  • Drug Albumin paclitaxel+SOX+BEV+ PD-1 monoclonal antibody therapy
    Albumin paclitaxel+SOX+BEV bi weekly neoadjuvant therapy for 6 cycles, with PD-1 monoclonal antibody therapy 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 two-week regimen of albumin paclitaxel+bevacizumab for 3 cycles, while PD-1 monoclonal antibody for 2 cycles. Afterwards, the therapeutic effect will be evaluated, and surgery

Primary outcome measures

  • Pathological response rate [Time frame: 3 year]
Secondary outcome measures (4)
  • EFS [Time frame: 3 year]
  • OS [Time frame: 3 year]
  • R0 [Time frame: 3 year]
  • Safety (adverse events) and surgical complications [Time frame: 3 year]

Eligibility criteria

Inclusion criteria

  • Local advanced diffuse or mixed type gastric cancer detected by pathology and endoscopy;
  • 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);
  • Has not received any anti-tumor treatment for gastric cancer yet;
  • Age range from 18 to 75 years old;
  • ECOG score 0-1 points;
  • 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;

  • Left ventricular ejection fraction>60%;
  • Good compliance and ability to accept long-term follow-up;
  • Sign informed consent.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Cancer hospital，Chinese acadamy of medical sciences — Beijing

Identifiers

NCT: NCT06371586 · NCC4537

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗