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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
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 25, 2022
    Last Updated
    May 25, 2022
    Sponsor
    Shanghai Zhongshan Hospital
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    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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