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Perioperative Chemotherapy Combined With Serplulimab or Placebo for pMMR Locally Advanced Gastric Adenocarcinoma (FOCUS-05)

ConditionsAdenocarcinoma of the StomachAdenocarcinoma of Esophagogastric JunctionProficient Mismatch Repair
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorYu jiren

About this trial

This phase II study is a prospective, multi-center, double-blinded, and randomized trial to compare the efficacy and safety of perioperative SOX plus serplulimab with SOX plus placebo for locally advanced gastric adenocarcinoma with proficient mismatch repair

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntary participation in the clinical study; fully understands and is informed of the study and has signed the Informed Consent Form (ICF).

The gender is not limited. Age: ≥ 18 years and ≤ 80 years old.

Gastric or esophagogastric junction adenocarcinoma confirmed by pathology, and proficient mismatch repair confirmed by immunohistochemistry.

Clinical stage at presentation: cT2-T4b, N+/-, M0 as determined by AJCC staging system, 8th edition.The definition of metastatic lymph nodes: a lymph node must be ≥ 10mm in short axis when assessed by CT scan (CT scan slice thickness recommended to be no greater than 5 mm) according to the guideline of Response Evaluation Criteria in Solid Tumours (RECIST version 1.1)

Disqualifiers

HER2-positive, EBER-positive or dMMR.

Prior systemic therapy for treatment of gastric cancer (surgery, chemotherapy, radiotherapy, targeted therapy or immunotherapy).

Previous or concurrent have other active malignant tumors within the past 5 years (except for basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate cancer or cervical cancer or breast cancer in situ that has undergone curative therapy).

Participants with gastric outlet obstruction, or unable for oral take, or severe gastrointestinal bleeding.

Trial design

Design model

Parallel

Treatments tested in this trial

  • S1

    Drug

    S-1 orally intake as perioperative chemotherapy

  • Oxaliplatin

    Drug

    Oxaliplatin (130 mg/m2) infusion as perioperative chemotherapy

  • Serplulimab

    Drug

    Perioperative serplulimab, 300 mg IV infusion

  • Placebo

    Drug

    Perioperative placebo, 300 mg IV infusion

Treatment groups

314 Participants
are divided into 2 treatment groups
Group A: Group A (Chemotherapy+Serplulimab )Experimental treatment 3 interventions
Group B: Group B (Chemotherapy+Placebo )Active comparator 3 interventions

Trial outcomes

Primary outcomes

1

Rate of pathological complete responses (pCR)

Percentage of patients with pCR referring to the total number of enrolled and eligible patients, as evaluated centrally by a reference pathologist.

Time frame
From enrollment to surgery after pre-operative treatment (up to approximately 36 months)

Secondary outcomes

1

Overall survival

Overall survival (OS) will be determined by measuring the time interval from enrollment to the end of follow up or death from any cause

Time frame
From enrollment to the end of follow up or death from any cause (up to approximately 60 months)
2

Progression-free survival

Progression-free survival (PFS) will be defined as the time from enrollment to the end of follow up or the time of disease progression or relapse or death from any cause

Time frame
From enrollment to the end of follow up or the time of disease progression or relapse or death from any cause (up to approximately 60 months)
3

The incidences and types of adverse events (AE) and severe adverse events (SAE)

The incidences and types of adverse events that occur during treatment will be evaluated according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Time frame
From enrollment to 90-day after the last dose administration (up to approximately 27 months)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yu jiren

Lead sponsor

First Affiliated Hospital of Zhejiang University

Sponsor institution

Source ClinicalTrials.gov
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