Actively Recruiting
AK104 in Combination With AK112 Plus Chemotherapy(SOX/XELOX) as First-line Treatment for Advanced G/GEJ Cancer
Led by Harbin Medical University · Updated on 2024-06-27
50
Participants Needed
1
Research Sites
150 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and anti-tumor activities of cadonilimab in combination with Ivonescimab plus chemotherapy as first-line therapy in adult subjects with HER2 negative、advanced or metastatic gastric (G) or gastroesophageal junction (GEJ) cancer.
CONDITIONS
Official Title
AK104 in Combination With AK112 Plus Chemotherapy(SOX/XELOX) as First-line Treatment for Advanced G/GEJ Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged 18 to 75 years
- Confirmed unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma with at least one measurable tumor lesion
- No prior systemic therapy for advanced disease; prior neoadjuvant/adjuvant therapy allowed if progression occurred at least 6 months after last treatment
- HER2-negative status confirmed by IHC and FISH/ISH testing
- Inclusion allowed for gastric cancer with peritoneal metastasis
- Expected survival longer than 3 months
- ECOG performance status of 0 or 1
- All acute toxicities from previous treatments resolved to grade 0-1 or acceptable levels
- Adequate organ function based on blood counts, liver and kidney tests, urine analysis, and coagulation parameters
- Negative pregnancy test for women of childbearing age; agreement to use contraception during treatment and 6 months after
- Signed informed consent and ability to follow study procedures
You will not qualify if you...
- Histology other than adenocarcinoma including squamous carcinoma or mixed tissue types
- HER2-positive gastric cancer (IHC 3+ or IHC 2+ with positive FISH/ISH)
- Prior treatment with immune checkpoint inhibitors, immune agonists, or immune cell therapies
- Uncontrolled pleural effusion or ascites despite treatment within 14 days before randomization
- Significant clinical bleeding or bleeding tendencies within 1 month before first treatment
- Active hemoptysis, diverticulitis, abdominal abscess, or gastrointestinal obstruction
- Other malignancies diagnosed within 5 years except certain cured skin, bladder, cervical, breast, or thyroid cancers
- Active or untreated brain or meningeal metastases, spinal cord compression, or leptomeningeal disease
- Interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic diseases
- Active autoimmune diseases requiring systemic immunosuppressive treatment
- Poorly controlled heart conditions including heart failure, unstable angina, recent myocardial infarction, significant arrhythmias, or prolonged QTc
- Recent major surgery or use of immunosuppressive drugs within defined timeframes before treatment
- Live attenuated vaccine within 28 days before or 60 days after study treatment
- Recent local anti-tumor treatments or use of Chinese herbal medicines with anti-tumor effects
- Known allergies or severe hypersensitivity to study drugs or monoclonal antibodies
- Conditions preventing safe drug intake or absorption
- Active HIV or hepatitis B/C infections
- Inability to comply with study procedures or follow-up
- Any condition that may increase risk or interfere with safety or study evaluations as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Harbin Medical University Hospital
Harbin, China
Actively Recruiting
Research Team
Y
yanqiao zhang, phD
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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