Actively Recruiting
Cadonilimab Combination Regimen as First-line Treatment for HER2-expressing GC/GEJ Patients
Led by Zhejiang Cancer Hospital · Updated on 2024-10-21
90
Participants Needed
1
Research Sites
181 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial is An open-label, multicohort, multicenter clinical study aimed at evaluating the efficacy and safety of the cadonilimab combination regimen in the treatment of advanced HER-2 positive gastric/gastroesophageal junction tumors
CONDITIONS
Official Title
Cadonilimab Combination Regimen as First-line Treatment for HER2-expressing GC/GEJ Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form.
- Age between 18 and 75 years.
- Histologically confirmed unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.
- Confirmed PD-L1 expression status.
- HER2 expression confirmed: Cohorts 1 and 2 require HER2-positive (IHC 3+ or IHC 2+ with positive ISH/FISH); Cohort 3 requires HER2 low expression (IHC 1+ or IHC 2+ with negative ISH/FISH).
- No prior systemic anti-tumor therapy.
- At least one measurable lesion based on RECIST 1.1 criteria.
- Expected survival of 3 months or more.
- ECOG performance status of 0 or 1.
- Adequate organ function as defined by blood counts, liver, kidney, coagulation, and cardiac function criteria.
- For premenopausal women, negative pregnancy test within 7 days before first dose and agreement to use effective contraception during treatment and for 120 days after last dose.
- Willingness to comply with trial schedule and follow-up procedures.
You will not qualify if you...
- Known squamous cell carcinoma, undifferentiated carcinoma, or other histological types of gastric cancer.
- Gastric cancer patients without HER2 expression.
- Active or untreated brain metastases, leptomeningeal metastases, spinal cord compression, or leptomeningeal disease.
- History of gastrointestinal perforation or fistula within 6 months unless surgically repaired and stable.
- Active diverticulitis, abdominal abscess, or gastrointestinal obstruction.
- Inability to swallow or malabsorption syndrome affecting drug intake.
- Clinically significant bleeding events or predisposition to bleeding within 1 month.
- Symptomatic moderate to severe ascites requiring therapeutic paracentesis.
- Uncontrolled or moderate to large pleural or pericardial effusions.
- Worsening primary disease during screening as judged by investigator.
- Active or history of inflammatory bowel disease.
- Major surgery within 4 weeks before treatment start or planned during study.
- Uncontrolled systemic diseases including diabetes, hypertension, lung disease, liver disease, severe arrhythmias, metabolic disorders, or severe peptic ulcer disease.
- Diagnosis of any malignancy other than gastric cancer within 5 years.
- Severe neurological or psychiatric disorders.
- Pregnant or breastfeeding women or planning to conceive.
- Cardiovascular disease or risk factors.
- Prior treatments with immune checkpoint inhibitors or antibody-drug conjugates targeting immune mechanisms.
- Toxicities from prior anticancer therapy not resolved to grade 1 or better, except specified exceptions.
- Use of systemic corticosteroids over 10 mg/day prednisone or equivalent within 14 days before first dose, with some exceptions.
- Known allergies or hypersensitivity to study drugs.
- Contraindications to oxaliplatin, capecitabine, fluorouracil, or leucovorin depending on cohort.
- Active autoimmune disease requiring systemic therapy within 2 years or judged likely to recur.
- Known interstitial lung disease or non-infectious pneumonia affecting treatment assessment.
- Active infection requiring IV antibiotics or antifungals within 2 weeks or fever of unknown cause during screening.
- Planned or prior solid organ or hematopoietic stem cell transplantation.
- Active hepatitis B, hepatitis C, immunodeficiency, or positive HIV test.
- Receipt or planned receipt of live vaccine within 28 days before first dose.
- Participation in another interventional clinical trial or conditions judged by investigator to increase risk or interfere with study evaluation.
- Noncompliance or other factors making participant unsuitable as judged by investigator.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
Research Team
J
Jieer Ying, MD
CONTACT
J
Jieer Ying
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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