search
Back to results

Exploratory Clinical Study of Penpulimab Combined With SOX in the Perioperative Treatment of Gastric Cancer

Primary Purpose

Gastric Cancer

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
S-1,Oxaliplatin, Penpulimab
Sponsored by
The Central Hospital of Lishui City
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Gastric Cancer, SOX, PD-1, perioperative period

Eligibility Criteria

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

Inclusion Criteria:

  • signed and dated informed consent;
  • At least 18 years of age;
  • ECOG PS: 0-1;
  • Patients with gastric cancer diagnosed as T3-4NXMX by imaging;
  • Patients with gastric adenocarcinoma diagnosed by cytology;
  • Patients with gastric cancer assessed by the surgeon as suitable for neoadjuvant therapy or conversion therapy followed by radical resection;
  • Laboratory tests should meet the following requirements (28 days before enrollment in baseline period) :
  • Women should agree that they must use contraception during and for 6 months after the study; Had a negative serum pregnancy test within 7 days prior to study enrollment and had to be non-lactating; Men should agree that they must use contraception during the study and for 6 months after the end of the study period.

Exclusion Criteria:

  • Co-existing with other malignant tumors (except cured basal cell carcinoma of the skin);
  • Gastric cancer patients with T1-2N0M0;
  • Previous treatment including anti-PD-1 /PD-L1/CTLA-4 antibody therapy or other immunotherapy directed against PD-1/PD-L1/CTLA-4;
  • Weight loss greater than or equal to 20% within 4 weeks before the first dose;
  • Severe hypersensitivity after administration of other monoclonal antibodies;
  • The presence or history of any active autoimmune disease
  • Immunosuppressive therapy, systemic or absorbable local hormone therapy (dose > 10mg/ day prednisone or other effective hormone) is required to achieve immunosuppression and continues to be used within 2 weeks of the first administration;
  • Patients with multiple factors affecting oral medication
  • Uncontrolled pleural effusion, pericardial effusion, or ascites that require repeated drainage;
  • Had received a prophylactic or attenuated vaccine within 4 weeks before the first dose;

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    SOX and Penpulimab

    Arm Description

    S-1 ( 40 mg/m2 bid po d1-14) and Penpulimab (200mg ivgtt d1) and Oxaliplatin ( 130 mg/m2 (d1) The treatment period of the above drugs was 3 weeks, and the duration of preoperative treatment was 3 cycles. After treatment, the patient underwent surgery after evaluation. Four cycles of adjuvant therapy with the original regimen (preoperative) were performed after surgery.

    Outcomes

    Primary Outcome Measures

    Pathological complete response(pCR)
    the proportion of patients got pathological complete response rate

    Secondary Outcome Measures

    The 1-year DFS rate
    the proportion of patients without relapse
    The 1-year OS rate
    OS was defined as the time from first day of study treatment to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up
    Disease free survival,DFS
    defined as, according to the RECIST1.1 criteria, the time between subjects from enrollment to disease recurrence or death (for any reason)
    Overall Response Rate (ORR)
    ORR was defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1
    tumor regression grade(TRG)
    Ryan's 0-3 classification method was used

    Full Information

    First Posted
    August 25, 2022
    Last Updated
    August 25, 2022
    Sponsor
    The Central Hospital of Lishui City
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05519202
    Brief Title
    Exploratory Clinical Study of Penpulimab Combined With SOX in the Perioperative Treatment of Gastric Cancer
    Official Title
    A Single-arm, Single-center Exploratory Clinical Study of Penpulimab Injection Combined With SOX in the Perioperative Treatment of Gastric Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 31, 2022 (Anticipated)
    Primary Completion Date
    August 31, 2023 (Anticipated)
    Study Completion Date
    August 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The Central Hospital of Lishui City

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    To explore the efficacy and safety of Penpulimab combined with SOX in the perioperative treatment of gastric cancer
    Detailed Description
    Gastric cancer is one of the malignant tumors that seriously threaten human health. It is the sixth most common malignant tumor in the world. According to Global Cancer Statistics 2020, there were about 1.089 million new cases of gastric cancer and 768,000 deaths of gastric cancer worldwide in 2020. Multidisciplinary treatment with radical surgical resection as the core is the mainstream mode of comprehensive treatment of gastric cancer at present, and radical gastrectomy is recognized as the best treatment. However, for patients with advanced gastric cancer, the effect of surgery alone is not good, and the postoperative tumor recurrence rate is high. In order to improve the disease-free survival rate and overall Surv Ival (OS) rate of gastric cancer patients after surgery, perioperative comprehensive therapy has been gradually adopted by the majority of scholars, and has achieved encouraging efficacy in clinical application.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastric Cancer
    Keywords
    Gastric Cancer, SOX, PD-1, perioperative period

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    SOX and Penpulimab
    Arm Type
    Experimental
    Arm Description
    S-1 ( 40 mg/m2 bid po d1-14) and Penpulimab (200mg ivgtt d1) and Oxaliplatin ( 130 mg/m2 (d1) The treatment period of the above drugs was 3 weeks, and the duration of preoperative treatment was 3 cycles. After treatment, the patient underwent surgery after evaluation. Four cycles of adjuvant therapy with the original regimen (preoperative) were performed after surgery.
    Intervention Type
    Drug
    Intervention Name(s)
    S-1,Oxaliplatin, Penpulimab
    Other Intervention Name(s)
    SOX and Penpulimab
    Intervention Description
    S-1 ( 40 mg/m2 bid po d1-14) and Penpulimab (200mg ivgtt d1) and Oxaliplatin ( 130 mg/m2 (d1)
    Primary Outcome Measure Information:
    Title
    Pathological complete response(pCR)
    Description
    the proportion of patients got pathological complete response rate
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    The 1-year DFS rate
    Description
    the proportion of patients without relapse
    Time Frame
    1 years
    Title
    The 1-year OS rate
    Description
    OS was defined as the time from first day of study treatment to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up
    Time Frame
    1 years
    Title
    Disease free survival,DFS
    Description
    defined as, according to the RECIST1.1 criteria, the time between subjects from enrollment to disease recurrence or death (for any reason)
    Time Frame
    2 years
    Title
    Overall Response Rate (ORR)
    Description
    ORR was defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1
    Time Frame
    2 years
    Title
    tumor regression grade(TRG)
    Description
    Ryan's 0-3 classification method was used
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: signed and dated informed consent; At least 18 years of age; ECOG PS: 0-1; Patients with gastric cancer diagnosed as T3-4NXMX by imaging; Patients with gastric adenocarcinoma diagnosed by cytology; Patients with gastric cancer assessed by the surgeon as suitable for neoadjuvant therapy or conversion therapy followed by radical resection; Laboratory tests should meet the following requirements (28 days before enrollment in baseline period) : Women should agree that they must use contraception during and for 6 months after the study; Had a negative serum pregnancy test within 7 days prior to study enrollment and had to be non-lactating; Men should agree that they must use contraception during the study and for 6 months after the end of the study period. Exclusion Criteria: Co-existing with other malignant tumors (except cured basal cell carcinoma of the skin); Gastric cancer patients with T1-2N0M0; Previous treatment including anti-PD-1 /PD-L1/CTLA-4 antibody therapy or other immunotherapy directed against PD-1/PD-L1/CTLA-4; Weight loss greater than or equal to 20% within 4 weeks before the first dose; Severe hypersensitivity after administration of other monoclonal antibodies; The presence or history of any active autoimmune disease Immunosuppressive therapy, systemic or absorbable local hormone therapy (dose > 10mg/ day prednisone or other effective hormone) is required to achieve immunosuppression and continues to be used within 2 weeks of the first administration; Patients with multiple factors affecting oral medication Uncontrolled pleural effusion, pericardial effusion, or ascites that require repeated drainage; Had received a prophylactic or attenuated vaccine within 4 weeks before the first dose;
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xu Hong Tao, MS
    Phone
    15024622762
    Email
    xht0071@sina.com

    12. IPD Sharing Statement

    Learn more about this trial

    Exploratory Clinical Study of Penpulimab Combined With SOX in the Perioperative Treatment of Gastric Cancer

    We'll reach out to this number within 24 hrs