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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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

Первичные конечные точки

• Pathological response rate [Срок оценки: 3 year]

Вторичные конечные точки (4)

• EFS [Срок оценки: 3 year]
• OS [Срок оценки: 3 year]
• R0 [Срок оценки: 3 year]
• Safety (adverse events) and surgical complications [Срок оценки: 3 year]

Критерии участия

Критерии включения

• Local advanced diffuse or mixed type gastric cancer detected by pathology and endoscopy;
• 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);
• Has not received any anti-tumor treatment for gastric cancer yet;
• Age range from 18 to 75 years old;
• ECOG score 0-1 points;
• 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;

• Left ventricular ejection fraction>60%;
• Good compliance and ability to accept long-term follow-up;
• Sign informed consent.

Критерии исключения

• Gastrointestinal obstruction or recurrent bleeding cannot be controlled;
• Those who cannot swallow pills;
• Diagnose immunodeficiency or active autoimmune diseases, have received or are currently receiving immunomodulators, systemic steroid therapy, or immunosuppressive drugs within the past two years;
• Interstitial pneumonia;
• Moderate to severe cirrhosis caused by any reason;
• Uncontrollable hypertension, severe kidney disease, and significant cardiovascular and cerebrovascular diseases;
• Active infections that require systemic treatment;
• Previously suffered from other tumors, excluding cured skin cancer and cervical cancer in situ;
• Internal medicine diseases that do not meet the chemotherapy criteria at the same time;
• Pregnant and lactating patients;
• Individuals with a history of mental illness and poor compliance.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Cancer hospital，Chinese acadamy of medical sciences — Пекин

Идентификаторы

NCT: NCT06371586 · NCC4537

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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