Actively Recruiting
An Open-label, Multicenter Phase II Trial Evaluating Safety and Efficacy of Simmitinib Plus Irinotecan Liposome in Advanced Esophageal Squamous Cell Carcinoma
Led by Shanghai Runshi Pharmaceutical Technology Co., Ltd · Updated on 2024-07-22
138
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of combining simmitinib with irinotecan liposome to treat advanced esophageal squamous cell carcinoma. This Phase II trial also studies how the body processes these drugs and explores links between biomarkers and treatment outcomes. The trial aims to improve options for patients whose cancer has progressed after first-line therapy. The study has two parts. The first part uses a dose escalation method to find the maximum tolerated dose of simmitinib plus irinotecan liposome. The second part is a randomized controlled trial where participants are assigned to one of three groups: simmitinib plus irinotecan liposome, irinotecan liposome alone, or irinotecan alone. Treatments are given every two weeks, with dosing based on body surface area. Participants will undergo assessments including monitoring for dose-limiting toxicities, adverse events, and tumor response over two years. Researchers will measure tumor shrinkage, disease control, progression-free survival, overall survival, and drug concentrations in the blood. Safety is closely followed from the first dose through 30 days after the last dose to ensure participant well-being.
CONDITIONS
Brief Title
A Study of Simmitinib Plus Irinotecan in Advanced Esophageal Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent voluntarily
- Aged 18 to 70 years, male or female
- Histologically or cytologically confirmed esophageal squamous cell carcinoma
- Disease progressed after only one prior standard first-line therapy
- At least one measurable lesion according to RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Expected survival longer than 3 months
- Adequate organ function as defined by blood counts and liver, kidney function tests
- Agree to use effective contraception during treatment and for 6 months after last dose if of childbearing potential
You will not qualify if you...
- Received any anti-tumor therapy within 4 weeks prior to first dose
- Received any live attenuated vaccine within 4 weeks before first dose or expected during study
- Prior treatment with anti-VEGF drugs, irinotecan, or other topoisomerase I inhibitors
- Left ventricular ejection fraction below 50%
- Body mass index less than 18.5 kg/m2
- Symptomatic central nervous system or meningeal metastases
- Other malignant tumors within 5 years except certain treated skin or cervical cancers
- Bleeding tendency or recent heavy bleeding within 6 months
- Significant proteinuria at screening
- Severe or uncontrolled diseases before treatment
- Severe lung disease within 6 months before first dose
- Active infections requiring intravenous antibiotics or steroids within 14 days prior to first dose
- Inability to swallow oral medication or significant gastrointestinal disorders
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.
1 visit (in-person)
Duration - Up to 28 days per cycle during dose escalation phase
Participants undergo dose escalation to determine the maximum tolerated dose of simmitinib plus irinotecan liposome.
Visits during each 28-day cycle in dose escalation phase
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive assigned treatment with simmitinib plus irinotecan liposome, irinotecan liposome, or irinotecan every 2 weeks as part of the randomized controlled study.
Biweekly visits for treatment administration
Duration - Up to 2 years
Participants are monitored for safety and efficacy outcomes after treatment completion.
Scheduled visits over 2 years for assessment
Trial Site Locations
Total: 1 location
1
Harbin Medical University Cancer Hospital
Heilongjiang, Harbin, China, 150076
Actively Recruiting
Research Team
C
Clinical Trials Information Group officer
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here