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NCT Number: NCT06371586

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

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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cancer hospital,Chinese acadamy of medical sciences

Beijing, China

Location status: Recruiting

Location contact

Chunxia Du

CONTACT

[email protected]

87787121

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

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, 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.

Other names: PSBP

Primary outcomes

  1. Pathological response rate

    Time frame: 3 year

    No residual cancer cells

Secondary outcomes

  1. EFS

    Time frame: 3 year

    event free survival

  2. OS

    Time frame: 3 year

    overall survival

  3. R0

    Time frame: 3 year

    Negative margin of incision

  4. Safety (adverse events) and surgical complications

    Time frame: 3 year

    Chemotherapy side effects and surgical safety

Study contacts

Contact information is provided by the study sponsor or research team.

Chunxia Du, MD

CONTACT

[email protected]

87787121

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 17, 2024
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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