Neoadjuvant Transcatheter Arterial Chemoinfusion and Embolism (TACiE) for Patients With Locally Advanced Adenocarcinoma of Stomach and Gastroesophageal Junction: a Prospective, Phase 2, Single Arm Trial.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Pathological complete response (pCR) rate
研究概览
简要总结
This is a prospective, single-center, single-arm, phase 2 trial to evaluate the feasibility and safety of neoadjuvant transcatheter infusion and embolism (TACiE) in patients with locally advanced adenocarcinoma of stomach and gastroesophageal junction.
The TACiE protocol includes four cycles. Transcatheter oxaliplatin and concurrent embolism on day 1 and oral S-1 on day 1-14 will be administrated in the first and third cycles. Intra-venous oxaliplatin on day 1 and oral S-1 on day 1-14 (SOX) will be administrated in the second and fourth cycles.
详细描述
The treatment of advanced gastric cancer has been a significant global health problem. With surgery still the backbone, many clinical trials have shown the benefit of perioperative treatment to gastric cancer patients. The neoadjuvant treatment is one of the most important parts.
Besides chemotherapy and chemoradiotherapy, the report of transcatheter arterial infusion (TAI) or transcatheter arterial embolism (TAE) in gastric cancer is relatively limited, though some case reports have showed its efficacy and safety in advanced gastric cancer. The combination of TAI and TAE (TACiE) may be more perspective in the treatment of gastric cancer. With transarterial infusion chemotherapy, TACiE increases the local concentration of chemotherapeutic agents and reduces adverse reaction. With embolization, TACiE blocks the blood supply and causes the necrosis of tumors, in this way exposing tumor antigen and promoting tumor immunity.
Based on those knowledges, we designed this prospective, single-center, single-arm, phase 2 trial to evaluate the feasibility and safety of neoadjuvant transcatheter infusion and embolism (TACiE) in patients with locally advanced adenocarcinoma of stomach and gastroesophageal junction. The primary purpose of this study is to evaluate the pathologic complete response (pCR) rate of TACiE. The second purpose is to evaluate pathologic response rate (pRR), objective Response Rate (ORR), overall survival (OS) and progression-free survival (PFS) of the patients enrolled in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 18 to 75 years old;
- •The Karnofsky Performance Scale (KPS) score >=80;
- •Adenocarcinoma of stomach and gastroesophageal junction (Siewert II/III) diagnosed pathologically;
- •clinical T3-4a/N+/M0 (The 8th edition of the American Joint Committee on Cancer (AJCC) staging system);
- •According to the Response Evaluation Criteria In Solid Tumours (RECIST) 1.1 standard, there is at least one evaluable lesion in the abdominal CT/MRI;
- •The surgeons participating in this study judged the lesion to be resectable;
- •Physical condition allows the surgery;
排除标准
- •Distant metastasis or local unresectable factors;
- •Cytotoxic chemotherapy, radiotherapy, immunotherapy or radical surgery for the treatment of this gastric cancer, except for corticosteroids;
- •Active autoimmune diseases or a history of autoimmune diseases;
- •History of malignant tumors within 2 years;
- •Gastrointestinal bleeding within two weeks prior to enrollment, or those with high bleeding risk;
- •Gastrointestinal perforation and/or fistula occurred within 6 months before enrollment;
- •Upper gastrointestinal obstruction or abnormal physiological function or suffering from malabsorption syndrome, which may affect the absorption of drugs;
- •Weight loss >=20% within 2 months before enrollment;
- •A history of the following lung diseases: interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, acute lung disease, etc.;
- •Uncontrollable systemic diseases including diabetes, hypertension, etc.; Severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis, HIV infection, etc.;
- •Untreated patients with chronic hepatitis B or chronic HBV carriers with hepatitis B virus (HBV) DNA exceeding 500 IU/mL, or hepatitis C virus (HCV) RNA positive patients should be excluded;
- •Any of the following cardiovascular risk factors (refer to Research Guide);
- •Known peripheral nerve disease >=NCI CTCAE Grade
- •However, patients with only the disappearance of the deep tendon reflex (DTR) need not be excluded;
- •Moderate or severe renal damage [creatinine clearance equal to or lower than 50 ml/min (calculated according to the Cockcroft and Gault equation)], or serum creatinine> upper limit of normal (ULN); People with known dihydropyrimidine dehydrogenase (DPD) deficiency;
- •Those who are allergic to any research drug ingredients;
- •Underwent major surgery within 28 days prior to enrollment;
研究组 & 干预措施
SOX-TACiE
Preoperative transcatheter arterial chemoinfusion and embolism alternated with intra-venus chemotherapy.
干预措施: Teysuno (Drug)
SOX-TACiE
Preoperative transcatheter arterial chemoinfusion and embolism alternated with intra-venus chemotherapy.
干预措施: Oxaliplatin (Drug)
SOX-TACiE
Preoperative transcatheter arterial chemoinfusion and embolism alternated with intra-venus chemotherapy.
干预措施: Transarterial chemoembolization (TACE) (Procedure)
结局指标
主要结局
Pathological complete response (pCR) rate
时间窗: two weeks after surgery
The percentage of patients found no tumor residual in primary tumor and resected lymph nodes.
次要结局
- Progressive free survival(From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months)
- Pathological response rate (pRR)(two weeks after surgery)
- Objective response rate (ORR)(up to 3 months)
- The incidence of treatment emergent adverse events.(up to 1 month after surgery.)
- Overall survival(From date of enrollment until the date of death from any cause, assessed up to 36 months)