Actively Recruiting
Study on Safety and Efficacy of Candenizumab, Lenvatinib, and SOX Regimen in Treating 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
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of candenizumab, lenvatinib, and the SOX regimen for treating patients with HER2 negative advanced gastric or gastroesophageal junction adenocarcinoma that cannot be removed by surgery. The study focuses on patients who have not previously received systemic treatment for their advanced or metastatic disease, aiming to measure the objective response rate and observe survival outcomes and safety. The sponsor is Fujian Medical University. The study includes a phase 1 ramp-up test to adjust the dose of lenvatinib, followed by phase 2 treatment with six cycles of the combined drugs given every three weeks. Patients who do not experience disease progression enter phase 3, which involves maintenance therapy with candenizumab, lenvatinib, and tigio also every three weeks. This multi-stage treatment plan is designed to evaluate the combination therapy's effects and safety over time. Participants will be monitored regularly with assessments of tumor response, survival times, and quality of life changes. Safety evaluations include tracking adverse events, dose adjustments, and treatment pauses. The study requires participants to have measurable lesions, normal organ function, and an estimated survival time longer than three months. The total study period extends through treatment and follow-up, allowing researchers to gather comprehensive data on treatment response and tolerability.
CONDITIONS
Brief 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 histopathology or cytology that cannot be surgically removed
- No prior radiotherapy, chemotherapy, targeted therapy, or immunotherapy as primary treatment for advanced or metastatic disease
- Previous adjuvant or neoadjuvant therapies allowed if last treatment was at least 6 months before randomization
- At least one measurable lesion
- ECOG performance status of 0 to 1
- Estimated survival time greater than 3 months
- Normal main organ function with specified blood and biochemical test levels
- Negative pregnancy test for women of childbearing age and agreement to use contraception during the trial and for 8 weeks after last drug administration
- For males, agreement to use contraception during the trial and for 8 weeks after last drug administration
- Not participating in other clinical studies before and during treatment
- Voluntary informed consent and ability to comply with follow-up
You will not qualify if you...
- Allergies or suspected allergies to study drugs or similar drugs
- Other malignant tumors within past 5 years except certain skin or cervical cancers
- Receipt of live vaccine within 4 weeks prior to or during the study
- Active or recent autoimmune diseases within 4 weeks before enrollment
- Prior allogeneic 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 causing bleeding or high risk of bleeding
- Recent significant bleeding events or thromboembolic events within specified timeframes
- Significant cardiovascular diseases or abnormalities within 6 months prior to enrollment
- Active or uncontrolled severe infections
- Known HIV infection
- Clinically significant liver disease or active viral hepatitis
- Any condition deemed unsuitable by researchers for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 6 cycles (approximately 18 weeks)
Participants receive a combination of candenizumab, lenvatinib, and SOX regimen over 6 cycles, with dosage adjustments in an initial ramp-up phase.
Treatment visits every 3 weeks (Q3W) during 6 cycles
Duration - Maintenance therapy duration varies
Participants who have not progressed enter maintenance therapy with candenizumab, lenvatinib, and tigio administered every 3 weeks.
Maintenance visits every 3 weeks (Q3W)
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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