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

Gastric Cancer Clinical Trial

Official title:

Neo-Sequence 2：Phase 2 Study of Neoadjuvant Chemotherapy Plus Anti-angiogenesis Therapy and Immunotherapy for Locally Advanced Diffuse Gastric Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06371586
• Other study ID #: NCC4537
• Status: Recruiting
• Phase: Phase 2
• Start date: March 1, 2024
• Est. completion date: March 1, 2027

Study information

• Verified date: April 2024
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Chunxia Du, MD
• Phone: 87787121
• Email: retinadcx[@]vip.163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 67
• Est. completion date: March 1, 2027
• Est. primary completion date: March 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Cancer hospital,Chinese acadamy of medical sciences	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological response rate	No residual cancer cells	3 year
Secondary	EFS	event free survival	3 year
Secondary	OS	overall survival	3 year
Secondary	R0	Negative margin of incision	3 year
Secondary	Safety (adverse events) and surgical complications	Chemotherapy side effects and surgical safety	3 year