Actively Recruiting
Perioperative Chemotherapy Plus Trastuzumab Plus Toripalimab in HER2 Positive Locally Advanced Gastric or Esophagogastric Junction Adenocarcinoma
Led by Yu jiren · Updated on 2024-09-19
30
Participants Needed
8
Research Sites
261 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a prospective, single arm, multi-center phase II clinical trial designed to evaluate the efficacy and safety of perioperative chemotherapy with FLOT regimen and trastuzumab in combination with toripalimab in participants with resectable HER2 positive locally advanced gastric or esophagogastric junction adenocarcinoma.
CONDITIONS
Official Title
Perioperative Chemotherapy Plus Trastuzumab Plus Toripalimab in HER2 Positive Locally Advanced Gastric or Esophagogastric Junction Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Gastric or esophagogastric junction adenocarcinoma confirmed by pathology
- HER2-positive status defined by IHC 3+ or IHC 2+ with FISH amplification
- Clinical stage cT2-T4b, N+/-, M0 by AJCC 8th edition
- ECOG performance status 0 or 1 within 7 days before treatment
- Life expectancy of at least 6 months
- Agreement to provide biopsy, surgical specimens, blood, feces, and urine samples for analysis
- Adequate hematological, hepatic, renal, coagulation, and cardiac function within 14 days before treatment
- Female participants of childbearing age must have a negative pregnancy test and agree to use contraception or abstain through specified periods
- Male participants must agree to use contraception or abstain through specified periods
You will not qualify if you...
- 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
- Recent myocardial infarction, uncontrolled angina, arrhythmia requiring intervention, or severe heart failure (NYHA class III or IV)
- Chronic watery diarrhea (5 or more times per day)
- Active infection requiring treatment within 14 days before treatment
- Active tuberculosis
- Interstitial lung disease diagnosis
- Positive tests for HIV, Hepatitis B surface antigen, or Hepatitis C antibody
- Need for long-term immunosuppressive therapy or systemic steroids over 10 mg/day prednisone equivalent within 14 days before or during study
- Severe allergic reactions to antibody-based drugs
- Autoimmune diseases except type I diabetes or hypothyroidism managed with hormone therapy
- Live vaccines within 28 days before or during study except inactivated flu vaccines
- History of organ or stem cell transplantation
- Uncontrolled systemic diseases like diabetes or hypertension
- Other serious physical or mental conditions or lab abnormalities increasing study risk
- Investigator judgment of unsuitability for study participation
AI-Screening
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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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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