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

NCT ID: NCT06371586

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2027-03-01

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.

Conditions

Gastric Cancer; Diffuse Type Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental arm

Neoadjuvant Chemotherapy Plus Anti-angiogenesis Therapy and Immunotherapy

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: DRUG

Other Intervention Names

PSBP

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chunxia Du, MD

Role: STUDY_CHAIR

Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Locations

Cancer hospital，Chinese acadamy of medical sciences

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Chunxia Du, MD

Role: CONTACT

retinadcx@vip.163.com

87787121

Facility Contacts

Chunxia Du

Role: primary

retinadcx@vip.163.com

87787121

Other Identifiers

NCC4537

Identifier Type: -

Identifier Source: org_study_id