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

NCT06036745 | Recruiting Phase 2

• 1 other identifier: Adjuvant K+SOX
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Gastric Cancer Stage IIIB-IIIC

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Overall survival

  3 years

• perioperative complications

  the time from the start of enrollment to 3 months after surgery

• Adverse Events

  the time from the start of enrollment to 90 days after using drugs/ 30 days after surgery

Study Arms (1)

Pembrolizumab + SOX

EXPERIMENTAL

Drug: Pembrolizumab + SOX

Interventions

Pembrolizumab + SOX DRUG

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

Pembrolizumab + SOX

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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:
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• 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.
• \. Women of reproductive age must be negative for serum or urine HCG within 72 hours prior to study entry. And must be non-lactating.

You may not qualify if:

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• 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 \&gt; 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.

Sponsors & Collaborators

• Shanghai Minimally Invasive Surgery Center: lead

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Zhenghao Cai

CONTACT

17316533505; c3z2h1@alumni.sjtu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: September 14, 2023
• Study Start: July 1, 2022
• Primary Completion: July 1, 2023
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 7, 2024

Record last verified: 2024-03

Locations

CN (1)