Image

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

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

Recruiting
18-75 years
All
Phase 2

Powered by AI

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.

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.

Eligibility

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.

Study details
    Gastric Cancer
    Diffuse Type Carcinoma

NCT06371586

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

30 April 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.