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

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

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer Stage IIIB-IIIC
• Intervention / Treatment: Drug: Pembrolizumab + SOX

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Zhenghao Cai; Phone Number: 17316533505; Email: c3z2h1@alumni.sjtu.edu.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Recruiting
      • Ruijin Hospital
      • Contact: CAI Zhenghao; Phone Number: 17316533505; Email: c3z2h1@alumni.sjtu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

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:

  1. Consistent with high-frequency microsatellite instability MSI-H
  2. Consistent with high tumor mutation load TMB-H (≥10 mutations/megabases)
  3. 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:
  1. Hemoglobin ≥90g/L;
  2. Absolute neutrophil count ≥1.5×109/ L;
  3. Platelet count ≥100×109/ L;
  4. aspartate or alanine aminotransferase ≤ 2.5 times the upper limit;

  5. 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:

  1. Patients with severe hypertension and poor drug control;
  2. Patients with difficulty in taking oral drugs due to dysphagia, complete or incomplete digestive tract obstruction, active gastrointestinal bleeding, perforation, etc.;
  3. People who are known to be allergic to the ingredients in the test drug or have metabolic disorders;
  4. Simultaneously participating in other tumor experimental drugs or being in other tumor clinical trials.
  5. 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;
  6. Patients with peripheral nervous system disorders or a history of obvious mental disorders and central nervous system disorders;
  7. Diagnosed with immunodeficiency or received systemic hormone therapy or other forms of immunosuppressive therapy within 7 days prior to initial administration;
  8. Active period > CTCAE (Version 5.0) grade 2 clinical severe infection;
  9. Pregnant and lactating women, women of childbearing age and their spouses refuse to take effective contraceptive methods;
  10. Persons without legal capacity, whose medical or ethical reasons affect the continuation of the research.
  11. 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

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pembrolizumab + SOX	Drug: Pembrolizumab + SOX; 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

Outcome Measure	Measure Description	Time Frame
Disease-free survival	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

Outcome Measure	Measure Description	Time Frame
Overall survival	the time from the start of surgery to death due to any cause.	3 years
perioperative complications	perioperative complications	the time from the start of enrollment to 3 months after surgery
Adverse Events	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: Shanghai Minimally Invasive Surgery Center

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): July 1, 2023
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: September 7, 2023
• First Submitted That Met QC Criteria: September 7, 2023
• First Posted (Actual): September 14, 2023

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

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: Adjuvant K+SOX

Drug and device information, study documents

• 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