Actively Recruiting
A Study on the Safety and Efficacy of the Combination of Candenizumab, Lenvatinib, and SOX Regimen in the Treatment of HER2 Negative Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Patients
Led by Fujian Medical University · Updated on 2024-02-26
50
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Evaluate the objective response rate (ORR) of the combination of candenizumab, lenvatinib, and SOX regimen for the treatment of HER2 negative advanced gastric or gastroesophageal junction adenocarcinoma patients
CONDITIONS
Official Title
A Study on the Safety and Efficacy of the Combination of Candenizumab, Lenvatinib, and SOX Regimen in the Treatment of HER2 Negative Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Locally advanced or metastatic HER2 negative gastric or gastroesophageal junction adenocarcinoma confirmed by biopsy
- No prior radiotherapy, chemotherapy, targeted therapy, or immunotherapy for advanced/metastatic disease
- Previous adjuvant or neoadjuvant treatment allowed if completed at least 6 months before
- At least one measurable tumor lesion
- ECOG performance status of 0 or 1
- Expected survival time greater than 3 months
- Normal organ function meeting specified blood and biochemical test criteria
- Negative pregnancy test for women of childbearing age and agreement to use contraception during and 8 weeks after study
- Males agree to use contraception during and 8 weeks after study
- Not participating in other clinical trials before or during this study
- Voluntary informed consent and ability to comply with study procedures
You will not qualify if you...
- Allergy or suspected allergy to study drugs or similar drugs
- Other cancers within past 5 years except certain skin or cervical cancers treated by surgery
- Received live vaccine within 4 weeks before or during study
- Active or recent autoimmune diseases within 4 weeks prior to enrollment
- Previous bone marrow or organ transplantation
- Conditions affecting drug absorption or inability to take oral medication
- Uncontrolled hypertension despite medication
- Significant proteinuria or urinary abnormalities
- Active gastrointestinal diseases or bleeding risks
- History of significant bleeding or thromboembolic events recently
- Serious cardiovascular diseases within 6 months prior
- Severe infections
- Known HIV infection
- Significant liver diseases including active hepatitis B or C
- Any condition deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Gastric Surgery， Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Actively Recruiting
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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