Exploratory Single-arm, Single-center Adjuvant Treatment of Stage IIIB-IIIC Gastric Cancer With Combination of Palizumab and SOX Regimen
An Exploratory Single-Arm, Single-Center Study of Pembrolizumab in Combination With SOX Regimen for Adjuvant Treatment of Stage IIIB-IIIC Gastric Cancer
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 2
Contacts and Locations
Study Contact
Study Contact
- Name: Zhenghao Cai
- Phone Number: 17316533505
- Email: c3z2h1@alumni.sjtu.edu.cn
Study Locations
-
-
Shanghai
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Shanghai, Shanghai, China, 200025
- Recruiting
- Ruijin Hospital
-
Contact:
- CAI Zhenghao
- Phone Number: 17316533505
- Email: c3z2h1@alumni.sjtu.edu.cn
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Pembrolizumab + SOX
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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
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Disease-free survival
Time Frame: 3 years
|
the time from the start of surgery to the incurable resection, local recurrence or metastasis, or death from any cause.
|
3 years
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall survival
Time Frame: 3 years
|
the time from the start of surgery to death due to any cause.
|
3 years
|
|
perioperative complications
Time Frame: the time from the start of enrollment to 3 months after surgery
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perioperative complications
|
the time from the start of enrollment to 3 months after surgery
|
|
Adverse Events
Time Frame: the time from the start of enrollment to 90 days after using drugs/ 30 days after surgery
|
occurs after a clinical trial subject receives a drug, but is not necessarily causally related to the treatment.
|
the time from the start of enrollment to 90 days after using drugs/ 30 days after surgery
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Stomach Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Immune Checkpoint Inhibitors
- Pembrolizumab
Other Study ID Numbers
Other Study ID Numbers
- Adjuvant K+SOX
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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