A Pilot Study of Neoadjuvant TACiE in Locally Advanced Gastric Cancer
Primary Purpose
Gastric Cancer
Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Oxaliplatin
Teysuno
Transarterial arterial chemoinfusion and embolism (TACiE)
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring neoadjuvant therapy, transcatheter arterial infusion, transcatheter arterial embolism, SOX
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.;
- 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;
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SOX-TACiE
Arm Description
Preoperative transcatheter arterial chemoinfusion and embolism (TACiE) alternated with systemic chemotherapy.
Outcomes
Primary Outcome Measures
The incidence of treatment related adverse events (TRAE).
The percentage of patients who developed TRAE
Secondary Outcome Measures
Pathological complete response (pCR) rate
The percentage of patients found no tumor residual in primary tumor and resected lymph nodes.
Objective response rate (ORR)
The percentage of patients found complete response or partial response to preoperative therapy according to RECIST v1.1.
Overall survival (OS)
The time from enrollment to death caused by any causes or censor.
Progressive free survival (PFS)
The time from enrollment to tumor progression, death or censor.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05396326
Brief Title
A Pilot Study of Neoadjuvant TACiE in Locally Advanced Gastric Cancer
Official Title
Neoadjuvant Transcatheter Arterial Chemoinfusion and Embolism (TACiE) for Patients With Locally Advanced Adenocarcinoma of Stomach and Gastroesophageal Junction: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2022 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Zhongshan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
neoadjuvant therapy, transcatheter arterial infusion, transcatheter arterial embolism, SOX
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SOX-TACiE
Arm Type
Experimental
Arm Description
Preoperative transcatheter arterial chemoinfusion and embolism (TACiE) alternated with systemic chemotherapy.
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
The first and third cycles : transcatheter arterial infusion of oxaliplatin 85mg/m2, day 1.
The second and fourth cycles: intra-venous oxaliplatin 135mg/m2, day 1.
Intervention Type
Drug
Intervention Name(s)
Teysuno
Intervention Description
Oral S-1, 40mg-60mg bid, day 1-14 for four 21-day cycles.
Intervention Type
Procedure
Intervention Name(s)
Transarterial arterial chemoinfusion and embolism (TACiE)
Intervention Description
In the first and third cycles : transcatheter arterial infusion of oxaliplatin 85mg/m2, day 1; transcatheter arterial embolism of tumor feeding arteries, day 1, if applicable.
Primary Outcome Measure Information:
Title
The incidence of treatment related adverse events (TRAE).
Description
The percentage of patients who developed TRAE
Time Frame
up to 28 days after last dose of preoperative therapy
Secondary Outcome Measure Information:
Title
Pathological complete response (pCR) rate
Description
The percentage of patients found no tumor residual in primary tumor and resected lymph nodes.
Time Frame
two weeks after surgery
Title
Objective response rate (ORR)
Description
The percentage of patients found complete response or partial response to preoperative therapy according to RECIST v1.1.
Time Frame
up to 3 months
Title
Overall survival (OS)
Description
The time from enrollment to death caused by any causes or censor.
Time Frame
From date of enrollment until the date of death from any cause, assessed up to 36 months
Title
Progressive free survival (PFS)
Description
The time from enrollment to tumor progression, death or censor.
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.;
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhaoqing Tang
Phone
+8613817125778
Email
tang.zhaoqing@zs-hospital.sh.cn
12. IPD Sharing Statement
Plan to Share IPD
No
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A Pilot Study of Neoadjuvant TACiE in Locally Advanced Gastric Cancer
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