Actively Recruiting
Perioperative Chemotherapy Combined With Serplulimab or Placebo for pMMR Locally Advanced Gastric Adenocarcinoma (FOCUS-05)
Led by Yu jiren · Updated on 2024-01-17
314
Participants Needed
5
Research Sites
279 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Perioperative Chemotherapy Combined With Serplulimab or Placebo for pMMR Locally Advanced Gastric Adenocarcinoma (FOCUS-05)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary participation with signed informed consent
- Age between 18 and 80 years
- Pathologically confirmed gastric or esophagogastric junction adenocarcinoma with proficient mismatch repair
- Clinical stage cT2-T4b, any N, M0 according to AJCC 8th edition
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- Life expectancy of at least 6 months
- Agreement to provide pretreatment biopsy and surgical specimens, along with blood, feces, and urine samples
- Adequate hematological function (WBC 3.5-12.0 x10^9/L; ANC ≥1.5 x10^9/L; platelets ≥100 x10^9/L; hemoglobin ≥90 g/L) within 14 days before treatment
- Adequate liver function (TBIL ≤1.5 x upper limit of normal; AST and ALT ≤2.5 x upper limit of normal; albumin ≥30 g/L)
- Adequate renal function (Creatinine ≤1.5 x upper limit of normal or creatinine clearance ≥60 ml/min if creatinine elevated)
- Adequate coagulation function (INR ≤1.5; PT and APTT ≤1.5 x upper limit of normal)
- Female participants of childbearing potential must have negative pregnancy tests within 7 days before treatment and agree to use contraception or abstain through the study period
- Male participants must agree to use contraception or abstain through the study period
You will not qualify if you...
- HER2-positive, EBER-positive, or deficient mismatch repair (dMMR) tumors
- Prior systemic therapy for gastric cancer including surgery, chemotherapy, radiotherapy, targeted therapy, or immunotherapy
- Other active malignant tumors within past 5 years except certain treated skin, bladder, prostate, cervical, or breast cancers
- Gastric outlet obstruction, inability to take oral medication, or severe gastrointestinal bleeding
- Myocardial infarction within 6 months, uncontrolled angina, arrhythmia requiring intervention, or severe heart failure (NYHA class III or IV)
- Chronic diarrhea with 5 or more watery stools per day
- Active infection requiring treatment within 14 days before treatment
- Active tuberculosis
- Interstitial lung disease diagnosis by imaging or symptoms
- Positive test for HIV, hepatitis B surface antigen, or hepatitis C antibody
- Need for long-term systemic steroids (>10 mg/day prednisone equivalent) or immunosuppressive therapy within 14 days before or during study
- History of severe allergic reactions to antibody-based drugs
- Presence of autoimmune diseases except type I diabetes or hypothyroidism treated only with hormone replacement
- Live vaccines within 28 days before or during study except inactivated influenza vaccine
- History of allogeneic organ or stem cell transplantation
- Systemic diseases difficult to control despite treatment
- Serious physical or mental illnesses or lab abnormalities increasing study risk
- Investigator judgment deeming participant unsuitable for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
2
The Second Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310003
Not Yet Recruiting
3
Lishui Central Hospital
Lishui, Zhejiang, China, 323000
Not Yet Recruiting
4
Ningbo Medical Center LiHuiLi Hospital
Ningbo, Zhejiang, China, 315048
Not Yet Recruiting
5
Taizhou Hospital
Taizhou, Zhejiang, China, 317099
Not Yet Recruiting
Research Team
J
Jiren Yu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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