Neoadjuvant Transcatheter Arterial Chemoinfusion and Embolism (TACiE) for Patients With Locally Advanced Adenocarcinoma of Stomach and Gastroesophageal Junction: a Pilot Study
Overview
- Phase
- Phase 1
- Intervention
- Oxaliplatin
- Conditions
- Gastric Cancer
- Sponsor
- Shanghai Zhongshan Hospital
- Enrollment
- 20
- Primary Endpoint
- The incidence of treatment related adverse events (TRAE).
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
This is a prospective pilot study to evaluate the safety and feasibility 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.
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 (TACiE) alternated with systemic chemotherapy.
Intervention: Oxaliplatin
SOX-TACiE
Preoperative transcatheter arterial chemoinfusion and embolism (TACiE) alternated with systemic chemotherapy.
Intervention: Teysuno
SOX-TACiE
Preoperative transcatheter arterial chemoinfusion and embolism (TACiE) alternated with systemic chemotherapy.
Intervention: Transarterial arterial chemoinfusion and embolism (TACiE)
Outcomes
Primary Outcomes
The incidence of treatment related adverse events (TRAE).
Time Frame: up to 28 days after last dose of preoperative therapy
The percentage of patients who developed TRAE
Secondary Outcomes
- Pathological complete response (pCR) rate(two weeks after surgery)
- Overall survival (OS)(From date of enrollment until the date of death from any cause, assessed up to 36 months)
- Objective response rate (ORR)(up to 3 months)
- Progressive free survival (PFS)(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)