Status:
UNKNOWN
Neoadjuvant TACiE in Locally Advanced Gastric Cancer
Lead Sponsor:
Shanghai Zhongshan Hospital
Conditions:
Gastric Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 aden...
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 gastri...
Eligibility Criteria
Inclusion
- 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
- 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 1. 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;
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2025
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT05346874
Start Date
June 1 2022
End Date
May 1 2025
Last Update
May 26 2022
Active Locations (1)
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1
ZhongShan hospital FuDan university
Shanghai, Shanghai Municipality, China, 200032