Clinical trial NCT06371586: Neo-Sequence 2：NCT Plus Anti-angiogenesis Therapy and Immunotherapy for LADGC
Official title: Neo-Sequence 2：Phase 2 Study of Neoadjuvant Chemotherapy Plus Anti-angiogenesis Therapy and Immunotherapy for Locally Advanced Diffuse Gastric Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Gastric Cancer
Diffuse Type Carcinoma
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pathological response rate
timeFrame: 3 year
Secondary outcomes:
measure: EFS
timeFrame: 3 year
measure: OS
timeFrame: 3 year
measure: R0
timeFrame: 3 year
measure: Safety (adverse events) and surgical complications
timeFrame: 3 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer hospital，Chinese acadamy of medical sciences
Study officials:
affiliation: Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
name: Chunxia Du, MD
role: STUDY_CHAIR
References: