search
Back to results

Exploratory Single-arm, Single-center Adjuvant Treatment of Stage IIIB-IIIC Gastric Cancer With Combination of Palizumab and SOX Regimen

Primary Purpose

Gastric Cancer Stage IIIB-IIIC

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Pembrolizumab + SOX
Sponsored by
Shanghai Minimally Invasive Surgery Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer Stage IIIB-IIIC

Eligibility Criteria

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

Inclusion Criteria: 1. Subjects voluntarily join the study and sign an informed consent form; 2. Male or female patients between the ages of 18-75; 3. Adenocarcinoma of the gastric/esophagogastric junction after radical resection was staged at stage IIIB-IIIC; 4. The molecular pathology of gastric cancer must meet at least one of the following three conditions: Consistent with high-frequency microsatellite instability MSI-H Consistent with high tumor mutation load TMB-H (≥10 mutations/megabases) High expression of PD-L1 (CPS score ≥5) 5. Expected survival time > 6 months; 6. ECOG (Eastern US Cooperative Oncology Group) score: 0-1 points; 7. Have not received anti-tumor immunotherapy; 8. Agree to provide archived tumor tissue samples for molecular testing; 9. Have good organ function: Hemoglobin ≥90g/L; Absolute neutrophil count ≥1.5×109/ L; Platelet count ≥100×109/ L; aspartate or alanine aminotransferase ≤ 2.5 times the upper limit; alkaline phosphatase ≤ 2.5 times the upper normal limit ; 10. Women of reproductive age who need to use a medically approved contraceptive method (such as an IUD, contraceptive pill, or condom) during the study treatment period and for 3 months after the end of the study treatment period; For men who agreed to use an appropriate method of contraception during the trial and for 3 months after the last dose of the trial drug. 11. Women of reproductive age must be negative for serum or urine HCG within 72 hours prior to study entry. And must be non-lactating. Exclusion Criteria: Patients with severe hypertension and poor drug control; Patients with difficulty in taking oral drugs due to dysphagia, complete or incomplete digestive tract obstruction, active gastrointestinal bleeding, perforation, etc.; People who are known to be allergic to the ingredients in the test drug or have metabolic disorders; Simultaneously participating in other tumor experimental drugs or being in other tumor clinical trials. Severe liver disease (such as cirrhosis, etc.), kidney disease, respiratory disease or uncontrollable diabetes, hypertension and other chronic system diseases; Clinically obvious heart disease, such as congestive heart failure, obvious coronary heart disease, medically difficult to control arrhythmia, hypertension, or myocardial infarction within 6 months, or cardiac insufficiency; Patients with peripheral nervous system disorders or a history of obvious mental disorders and central nervous system disorders; Diagnosed with immunodeficiency or received systemic hormone therapy or other forms of immunosuppressive therapy within 7 days prior to initial administration; Active period > CTCAE (Version 5.0) grade 2 clinical severe infection; Pregnant and lactating women, women of childbearing age and their spouses refuse to take effective contraceptive methods; Persons without legal capacity, whose medical or ethical reasons affect the continuation of the research. Other conditions determined by the investigator to be unsuitable for inclusion in the study.

Sites / Locations

  • Ruijin HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pembrolizumab + SOX

Arm Description

Outcomes

Primary Outcome Measures

Disease-free survival
the time from the start of surgery to the incurable resection, local recurrence or metastasis, or death from any cause.

Secondary Outcome Measures

Overall survival
the time from the start of surgery to death due to any cause.
perioperative complications
perioperative complications
Adverse Events
occurs after a clinical trial subject receives a drug, but is not necessarily causally related to the treatment.

Full Information

First Posted
September 7, 2023
Last Updated
September 7, 2023
Sponsor
Shanghai Minimally Invasive Surgery Center
search

1. Study Identification

Unique Protocol Identification Number
NCT06036745
Brief Title
Exploratory Single-arm, Single-center Adjuvant Treatment of Stage IIIB-IIIC Gastric Cancer With Combination of Palizumab and SOX Regimen
Official Title
An Exploratory Single-Arm, Single-Center Study of Pembrolizumab in Combination With SOX Regimen for Adjuvant Treatment of Stage IIIB-IIIC Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
July 1, 2023 (Actual)
Study Completion Date
July 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Minimally Invasive Surgery Center

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
it is an an Exploratory Single-Arm, Single-Center Study of Pembrolizumab in Combination with SOX Regimen for Adjuvant Treatment of Stage IIIB-IIIC Gastric Cancer

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer Stage IIIB-IIIC

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
Pembrolizumab + SOX
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab + SOX
Intervention Description
Pembrolizumab 200mg, ivdrip, q3w; Oxaliplatin 135mg/m2, ivdrip,q3w; Trastuzumab 40 mg/m2,po bid,d1~d14,q21d. Each cycle consists of three weeks, totaling eight cycles
Primary Outcome Measure Information:
Title
Disease-free survival
Description
the time from the start of surgery to the incurable resection, local recurrence or metastasis, or death from any cause.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Overall survival
Description
the time from the start of surgery to death due to any cause.
Time Frame
3 years
Title
perioperative complications
Description
perioperative complications
Time Frame
the time from the start of enrollment to 3 months after surgery
Title
Adverse Events
Description
occurs after a clinical trial subject receives a drug, but is not necessarily causally related to the treatment.
Time Frame
the time from the start of enrollment to 90 days after using drugs/ 30 days after surgery

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: 1. Subjects voluntarily join the study and sign an informed consent form; 2. Male or female patients between the ages of 18-75; 3. Adenocarcinoma of the gastric/esophagogastric junction after radical resection was staged at stage IIIB-IIIC; 4. The molecular pathology of gastric cancer must meet at least one of the following three conditions: Consistent with high-frequency microsatellite instability MSI-H Consistent with high tumor mutation load TMB-H (≥10 mutations/megabases) High expression of PD-L1 (CPS score ≥5) 5. Expected survival time > 6 months; 6. ECOG (Eastern US Cooperative Oncology Group) score: 0-1 points; 7. Have not received anti-tumor immunotherapy; 8. Agree to provide archived tumor tissue samples for molecular testing; 9. Have good organ function: Hemoglobin ≥90g/L; Absolute neutrophil count ≥1.5×109/ L; Platelet count ≥100×109/ L; aspartate or alanine aminotransferase ≤ 2.5 times the upper limit; alkaline phosphatase ≤ 2.5 times the upper normal limit ; 10. Women of reproductive age who need to use a medically approved contraceptive method (such as an IUD, contraceptive pill, or condom) during the study treatment period and for 3 months after the end of the study treatment period; For men who agreed to use an appropriate method of contraception during the trial and for 3 months after the last dose of the trial drug. 11. Women of reproductive age must be negative for serum or urine HCG within 72 hours prior to study entry. And must be non-lactating. Exclusion Criteria: Patients with severe hypertension and poor drug control; Patients with difficulty in taking oral drugs due to dysphagia, complete or incomplete digestive tract obstruction, active gastrointestinal bleeding, perforation, etc.; People who are known to be allergic to the ingredients in the test drug or have metabolic disorders; Simultaneously participating in other tumor experimental drugs or being in other tumor clinical trials. Severe liver disease (such as cirrhosis, etc.), kidney disease, respiratory disease or uncontrollable diabetes, hypertension and other chronic system diseases; Clinically obvious heart disease, such as congestive heart failure, obvious coronary heart disease, medically difficult to control arrhythmia, hypertension, or myocardial infarction within 6 months, or cardiac insufficiency; Patients with peripheral nervous system disorders or a history of obvious mental disorders and central nervous system disorders; Diagnosed with immunodeficiency or received systemic hormone therapy or other forms of immunosuppressive therapy within 7 days prior to initial administration; Active period > CTCAE (Version 5.0) grade 2 clinical severe infection; Pregnant and lactating women, women of childbearing age and their spouses refuse to take effective contraceptive methods; Persons without legal capacity, whose medical or ethical reasons affect the continuation of the research. Other conditions determined by the investigator to be unsuitable for inclusion in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhenghao Cai
Phone
17316533505
Email
c3z2h1@alumni.sjtu.edu.cn
Facility Information:
Facility Name
Ruijin Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CAI Zhenghao
Phone
17316533505
Email
c3z2h1@alumni.sjtu.edu.cn

12. IPD Sharing Statement

Learn more about this trial

Exploratory Single-arm, Single-center Adjuvant Treatment of Stage IIIB-IIIC Gastric Cancer With Combination of Palizumab and SOX Regimen

We'll reach out to this number within 24 hrs