Actively Recruiting
Perioperative Chemotherapy Plus Toripalimab for dMMR Locally Advanced Gastric or Esophagogastric Junction Adenocarcinoma
Led by Yu jiren · Updated on 2023-07-25
90
Participants Needed
8
Research Sites
300 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a prospective, multi-center, randomized controlled phase II trial to compare the efficacy of perioperative SOX plus toripalimab, toripalimab monotherapy with SOX regimen in participants with dMMR locally advanced gastric or esophagogastric junction adenocarcinoma
CONDITIONS
Official Title
Perioperative Chemotherapy Plus Toripalimab for dMMR Locally Advanced Gastric or Esophagogastric Junction Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary participation with signed informed consent
- Male or female aged 18 to 80 years
- Histopathologically confirmed gastric or esophagogastric junction adenocarcinoma
- Mismatch repair deficient (dMMR) adenocarcinoma confirmed by immunohistochemistry
- Clinical stage cT2-4bN+/-, M0 according to AJCC-UICC TNM classification (8th edition)
- ECOG performance status 0-1 within 7 days before first treatment dose
- Life expectancy of at least 6 months
- Agreement to provide baseline and surgical specimens for biomarker analysis
- Adequate vital organ function within 14 days before first treatment dose, including hematological, hepatic, renal, and coagulation parameters
- Female participants of childbearing potential must have a negative pregnancy test within 7 days before treatment and agree to use contraception or abstinence through specified periods; male participants must agree to use contraception or abstinence
You will not qualify if you...
- HER2-positive status defined by IHC 3+ or IHC 2+ with FISH amplification
- Prior systemic therapy for gastric cancer including surgery, chemotherapy, radiotherapy, targeted therapy, or immunotherapy
- Other active malignant tumors within past 5 years except certain skin, bladder, prostate, cervical, or breast cancers treated curatively
- Gastric outlet obstruction, inability to take oral medications, or severe gastrointestinal bleeding
- Recent myocardial infarction (within 6 months), uncontrolled angina, arrhythmia requiring intervention, or severe heart failure (NYHA class III or IV)
- Chronic watery diarrhea of 5 or more times per day
- Active infection requiring treatment within 14 days before first treatment dose
- Active tuberculosis
- Interstitial lung disease diagnosis
- Positive tests for HIV antibody, 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 treatment or during study
- Severe allergic reactions to antibody-based drugs
- Concurrent autoimmune diseases except diabetes mellitus type I or hypothyroidism on hormone therapy
- Live vaccines within 28 days before treatment or during study, except for inactivated influenza vaccines
- History of allogeneic organ or hematopoietic stem cell transplantation
- Difficult to control systemic diseases such as diabetes or hypertension
- Serious physical or mental diseases 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: 8 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
Huzhou Central Hospital
Huzhou, Zhejiang, China, 313099
Not Yet Recruiting
4
Lishui Central Hospital
Lishui, Zhejiang, China, 323000
Not Yet Recruiting
5
Ningbo First Hospital
Ningbo, Zhejiang, China, 315010
Not Yet Recruiting
6
Ningbo Medical Center LiHuiLi Hospital
Ningbo, Zhejiang, China, 315048
Not Yet Recruiting
7
Ningbo Second Hospital
Ningbo, Zhejiang, China, 315099
Not Yet Recruiting
8
Taizhou Hospital
Taizhou, Zhejiang, China, 317099
Not Yet Recruiting
Research Team
J
Jiren Yu
CONTACT
K
Kankai Zhu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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