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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Minimally Invasive Surgery Center

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Consistent with high-frequency microsatellite instability MSI-H

Consistent with high tumor mutation load TMB-H (≥10 mutations/megabases)

Hemoglobin ≥90g/L;

Absolute neutrophil count ≥1.5×109/ L;

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Pembrolizumab + SOXExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
3 years

Secondary outcomes

1

Overall survival

the time from the start of surgery to death due to any cause.

Time frame
3 years
2

perioperative complications

perioperative complications

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

Adverse Events

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

Other outcomes

Sponsors and contacts

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