Actively Recruiting
A Study of Simmitinib Plus Irinotecan 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
98 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the safety and efficacy of simmitinib plus irinotecan liposome in the treatment of advanced esophageal squamous cell carcinoma, and to evaluate the PK of the drug and the correlation between biomarkers and clinical efficacy of simmitinib plus irinotecan liposome.
CONDITIONS
Official 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 for the study
- Age 18 to 70 years, male or female
- Histologically or cytologically confirmed esophageal squamous cell carcinoma
- Disease progression after only first-line standard therapy (chemotherapy with platinum plus fluorouracil or taxane combined with immunosuppressive regimen)
- At least one measurable lesion per RECIST 1.1
- ECOG performance status score of 0-1
- Expected survival longer than 3 months
- Adequate organ function including ANC 21.5 �D7 10^9/L, platelet count 2175 �D7 10^9/L, hemoglobin 2190 g/L, liver enzymes 2.5 �D7 ULN (or 5.0 �D7 ULN for liver metastases), bilirubin 1.5 �D7 ULN, creatinine 1.5 �D7 ULN, creatinine clearance 260 mL/min, and coagulation times 1.5 �D7 ULN
- 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 before 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 less than 50%
- Body mass index less than 18.5 kg/m^2
- Symptomatic central nervous system or meningeal metastases
- Other malignant tumors within 5 years except certain non-recurrent skin or carcinoma in situ cancers
- Bleeding tendency, active bleeding, or history of heavy bleeding within past 6 months
- Urine protein 2 or 24-hour urine protein over 1.0 g at screening
- Severe or uncontrolled diseases before treatment
- Severe lung disease within 6 months prior to dosing
- Active infection requiring intravenous antibiotics or hormones within 14 days before first dose
- Unable to swallow oral drugs or significant gastrointestinal disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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