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.
Overview
- Phase
- Phase 2
- Intervention
- Teysuno
- Conditions
- Gastric Cancer
- Sponsor
- Shanghai Zhongshan Hospital
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- Pathological complete response (pCR) rate
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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;
Exclusion Criteria
- •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.;
Arms & Interventions
SOX-TACiE
Preoperative transcatheter arterial chemoinfusion and embolism alternated with intra-venus chemotherapy.
Intervention: Teysuno
SOX-TACiE
Preoperative transcatheter arterial chemoinfusion and embolism alternated with intra-venus chemotherapy.
Intervention: Oxaliplatin
SOX-TACiE
Preoperative transcatheter arterial chemoinfusion and embolism alternated with intra-venus chemotherapy.
Intervention: Transarterial chemoembolization (TACE)
Outcomes
Primary Outcomes
Pathological complete response (pCR) rate
Time Frame: two weeks after surgery
The percentage of patients found no tumor residual in primary tumor and resected lymph nodes.
Secondary Outcomes
- 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)