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Disitamab Vedotin Combined With Sintilimab as First-line Treatment of Elderly Patients With Gastric Cancer

Primary Purpose

Gastric Cancer

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Disitamab Vedotin Combined With Sintilimab
Sponsored by
Tianjin Medical University Cancer Institute and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 1) Volunteer to take part in the study ; 2) Age ≥65 , male or female; 3) Gastric cancer or adenocarcinoma of gastroesophageal junction confirmed by histology and/or cytology; 4) Have not received systematic treatment; If the subject has received adjuvant therapy after completing radical treatment for early gastric cancer and the subject has relapsed disease, ensure that the end of adjuvant therapy is more than 6 months from the first dose of the study and that various toxicities due to the adjuvant therapy have recovered. 5) The HER2 immunohistochemistry (IHC) test result is IHC 3+or 2+, and the previous test results of the subject (confirmed by the investigator) are acceptable; 6) At least one assessable lesion (RECIST 1.1 ); 7) Expected survival time ≥ 6 months; 8) ECOG 0-2; 9) If the main organs function normally, they meet the following standards: Blood routine examination (no blood transfusion and G-CSF use within 14 days before screening): Hemoglobin ≥ 90 g/L; Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; White blood cell count ≥ 3.0 × 109/L; Platelet count ≥ 80 × 109/L; Blood biochemical examination (albumin was not used within 14 days before screening): Albumin ≥ 28 g/L; Total bilirubin ≤ 2 × Upper limit of normal value (ULN); In the absence of liver metastasis, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) ≤ 2.5 × ULN; ALT, AST and ALP ≤ 5× ULN in case of liver metastasis ; Alkaline phosphatase (ALP) ≤ 5 × ULN; Creatinine ≤ 1.5 × ULN; Or the creatinine clearance rate (CrCl) calculated by Cockcroft Gault formula is ≥ 50 mL/min; Coagulation function: International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN; j) Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN。 Exclusion Criteria: 1) Have a history of malignant tumors other than gastric cancer, except for the following two cases: The patient has received possible curative treatment and there is no evidence of the disease within 5 years; The resected skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ and other carcinoma in situ were successfully received; 2) Have received allogeneic stem cells or solid organ transplantation in the past; 3) Patients who have received other anti-tumor systemic therapy in the past (including traditional Chinese medicine with anti-tumor indications), and have been less than 4 weeks from the completion of treatment to the administration of this study, or the adverse events caused by previous treatment have not recovered to ≤ CTCAE level 1 (except hair loss and pigmentation); 4) Previous or current congenital or acquired immunodeficiency disease; 5) Allergic to the study drug; 6) Other significant clinical and laboratory abnormalities, which the researchers think affect the safety evaluation; 7) Serious infection in active period or poorly controlled clinically; 8) Not recovered from the operation; 9) Pregnant or lactating women, and women or men with fertility who are unwilling or unable to take effective contraceptive measures; 10) Other situations that the investigator thinks are not suitable for inclusion.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Disitamab Vedotin Combined With Sintilimab

    Arm Description

    Treatment regimen is Disitamab vedotin 2.5mg/kg and Sintilimab 200mg every 21 days, until disease progression or intolerable adverse reactions or death.

    Outcomes

    Primary Outcome Measures

    PFS (Progression-Free-Survival)
    The time from randomization to tumor progression or death.The efficacy of this study was determined according to Recist version 1.1 criteria.

    Secondary Outcome Measures

    ORR(Objective Response Rate)
    The rate of participants that achieve either a complete response (CR) or a partial response (PR).
    DCR(Disease control rate)
    The percentage of cases with remission (PR + CR) and stable lesions (SD) after treatment was assessable.
    DOR(Duration of response)
    DoR was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression. The time of the initial response was defined as the latest of the dates contributing toward the first visit response of CR or PR. If a patient did not progress following a response, then their DoR was censored at the PFS censoring time.
    OS (Overall survival time)
    The time of death from all causes for all patients from the date of randomization.
    The Adverse Events
    AEs are any adverse medical events that occur in a subject or clinical subject and is not necessarily causally related to the treatment. Safety assessment in this study was conducted by the investigator in accordance with the definition of CTCAE 5.0.

    Full Information

    First Posted
    January 31, 2023
    Last Updated
    January 31, 2023
    Sponsor
    Tianjin Medical University Cancer Institute and Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05720533
    Brief Title
    Disitamab Vedotin Combined With Sintilimab as First-line Treatment of Elderly Patients With Gastric Cancer
    Official Title
    Safety and Efficacy of Disitamab Vedotin Combined With Sintilimab as First-line Treatment of Elderly Patients With HER2 Overexpression Gastric Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 1, 2023 (Anticipated)
    Primary Completion Date
    March 1, 2024 (Anticipated)
    Study Completion Date
    March 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Tianjin Medical University Cancer Institute and Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study aims to explore the safety and efficacy of Disitamab vedotin combined with Sintilimab in elderly patients with HER2 overexpression Gastric Cancer. This is a single-arm exploratory clinical study. 20 patients with eHER2 overexpression gastric cancer are scheduled to be enrolled. Treatment regimen is Disitamab vedotin 2.5mg/kg and Sintilimab 200mg every 21 days, until disease progression or intolerable adverse reactions or death.
    Detailed Description
    The primary objective of this study was to explore the safety and median PFS of Disitamab vedotin combined with Sintilimab as first-line treatment in elderly patients with HER2 overexpression Gastric Cancer.The secondary objective of this study was to evaluate the ORR, DCR, DOR and OS of Disitamab vedotin combined with Sintilimab as first-line treatment in elderly patients with HER2 overexpression Gastric Cancer.To provide a better treatment plan for elderly patients with Gastric Cancer.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastric Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Disitamab Vedotin Combined With Sintilimab
    Arm Type
    Experimental
    Arm Description
    Treatment regimen is Disitamab vedotin 2.5mg/kg and Sintilimab 200mg every 21 days, until disease progression or intolerable adverse reactions or death.
    Intervention Type
    Drug
    Intervention Name(s)
    Disitamab Vedotin Combined With Sintilimab
    Other Intervention Name(s)
    Combined treatment group
    Intervention Description
    Disitamab Vedotin injection:2.5mg/kg,IV,Q3W Sintilimab injection:200mg,IV, Q3W
    Primary Outcome Measure Information:
    Title
    PFS (Progression-Free-Survival)
    Description
    The time from randomization to tumor progression or death.The efficacy of this study was determined according to Recist version 1.1 criteria.
    Time Frame
    24 months
    Secondary Outcome Measure Information:
    Title
    ORR(Objective Response Rate)
    Description
    The rate of participants that achieve either a complete response (CR) or a partial response (PR).
    Time Frame
    24 months
    Title
    DCR(Disease control rate)
    Description
    The percentage of cases with remission (PR + CR) and stable lesions (SD) after treatment was assessable.
    Time Frame
    24 months
    Title
    DOR(Duration of response)
    Description
    DoR was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression. The time of the initial response was defined as the latest of the dates contributing toward the first visit response of CR or PR. If a patient did not progress following a response, then their DoR was censored at the PFS censoring time.
    Time Frame
    24 months
    Title
    OS (Overall survival time)
    Description
    The time of death from all causes for all patients from the date of randomization.
    Time Frame
    24 months
    Title
    The Adverse Events
    Description
    AEs are any adverse medical events that occur in a subject or clinical subject and is not necessarily causally related to the treatment. Safety assessment in this study was conducted by the investigator in accordance with the definition of CTCAE 5.0.
    Time Frame
    24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 1) Volunteer to take part in the study ; 2) Age ≥65 , male or female; 3) Gastric cancer or adenocarcinoma of gastroesophageal junction confirmed by histology and/or cytology; 4) Have not received systematic treatment; If the subject has received adjuvant therapy after completing radical treatment for early gastric cancer and the subject has relapsed disease, ensure that the end of adjuvant therapy is more than 6 months from the first dose of the study and that various toxicities due to the adjuvant therapy have recovered. 5) The HER2 immunohistochemistry (IHC) test result is IHC 3+or 2+, and the previous test results of the subject (confirmed by the investigator) are acceptable; 6) At least one assessable lesion (RECIST 1.1 ); 7) Expected survival time ≥ 6 months; 8) ECOG 0-2; 9) If the main organs function normally, they meet the following standards: Blood routine examination (no blood transfusion and G-CSF use within 14 days before screening): Hemoglobin ≥ 90 g/L; Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; White blood cell count ≥ 3.0 × 109/L; Platelet count ≥ 80 × 109/L; Blood biochemical examination (albumin was not used within 14 days before screening): Albumin ≥ 28 g/L; Total bilirubin ≤ 2 × Upper limit of normal value (ULN); In the absence of liver metastasis, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) ≤ 2.5 × ULN; ALT, AST and ALP ≤ 5× ULN in case of liver metastasis ; Alkaline phosphatase (ALP) ≤ 5 × ULN; Creatinine ≤ 1.5 × ULN; Or the creatinine clearance rate (CrCl) calculated by Cockcroft Gault formula is ≥ 50 mL/min; Coagulation function: International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN; j) Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN。 Exclusion Criteria: 1) Have a history of malignant tumors other than gastric cancer, except for the following two cases: The patient has received possible curative treatment and there is no evidence of the disease within 5 years; The resected skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ and other carcinoma in situ were successfully received; 2) Have received allogeneic stem cells or solid organ transplantation in the past; 3) Patients who have received other anti-tumor systemic therapy in the past (including traditional Chinese medicine with anti-tumor indications), and have been less than 4 weeks from the completion of treatment to the administration of this study, or the adverse events caused by previous treatment have not recovered to ≤ CTCAE level 1 (except hair loss and pigmentation); 4) Previous or current congenital or acquired immunodeficiency disease; 5) Allergic to the study drug; 6) Other significant clinical and laboratory abnormalities, which the researchers think affect the safety evaluation; 7) Serious infection in active period or poorly controlled clinically; 8) Not recovered from the operation; 9) Pregnant or lactating women, and women or men with fertility who are unwilling or unable to take effective contraceptive measures; 10) Other situations that the investigator thinks are not suitable for inclusion.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zhansheng Jiang, Doctor
    Phone
    13512035574
    Email
    zhjiang@tmu.edu.cn

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Disitamab Vedotin Combined With Sintilimab as First-line Treatment of Elderly Patients With Gastric Cancer

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