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

Phase 2

Recruiting

• Conditions: Diffuse Type Carcinoma; Gastric Cancer
• Interventions: Drug: Albumin paclitaxel+SOX+BEV+ PD-1 monoclonal antibody therapy

• Registration Number: NCT06371586
• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Brief 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.

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.

Study Timeline

• Study Start: 2024-03-01
• Status Verified: 2024-04
• Study First Submitted: 2024-04-14
• Study First Submitted QC: 2024-04-14
• Last Update Submitted: 2024-04-14
• Study First Posted: 2024-04-17
• Last Update Posted: 2024-04-17
• Primary Completion: 2027-03-01
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 67

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental arm	Albumin paclitaxel+SOX+BEV+ PD-1 monoclonal antibody therapy	Neoadjuvant Chemotherapy Plus Anti-angiogenesis Therapy and Immunotherapy

Primary Outcome Measures

Name	Time	Method
Pathological response rate	3 year	No residual cancer cells

Secondary Outcome Measures

Name	Time	Method
OS	3 year	overall survival
R0	3 year	Negative margin of incision
EFS	3 year	event free survival
Safety (adverse events) and surgical complications	3 year	Chemotherapy side effects and surgical safety

Trial Locations

Locations (1)

Cancer hospital，Chinese acadamy of medical sciences; 🇨🇳 Beijing, China