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

RECRUITINGPhase 2Sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Actively Recruiting
PhasePhase 2
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
Started2024-03-01
Est. completion2027-03-01
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted

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

Age: 18 Years – 75 YearsHealthy volunteers accepted
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.

Conditions3

CancerDiffuse Type CarcinomaGastric Cancer

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