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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Enrolling; Phase 2

Conditions: Gastric Cancer; Diffuse Type Carcinoma

Treatments: Drug: Albumin paclitaxel+SOX+BEV+ PD-1 monoclonal antibody therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06371586

NCC4537

Details and patient eligibility

About

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.

Full 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.

Enrollment: 67 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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67 participants in 1 patient group

Experimental arm

Experimental group

Description:

Neoadjuvant Chemotherapy Plus Anti-angiogenesis Therapy and Immunotherapy

Treatment:

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