RecruitingPhase 2NCT06512428

A Study of Simmitinib Plus Irinotecan in Advanced Esophageal Squamous Cell Carcinoma

An Open-label, Multicenter Phase II Clinical Trial to Explore the Safety and Efficacy of Simmitinib Plus Irinotecan Liposome in Patients With Advanced Esophageal Squamous Cell Carcinoma


Sponsor

Shanghai Runshi Pharmaceutical Technology Co., Ltd

Enrollment

138 participants

Start Date

Mar 15, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — simmitinib (a targeted therapy) and irinotecan (a chemotherapy) — as a second-line treatment for people with advanced esophageal squamous cell cancer whose disease progressed after standard first-line treatment. **You may be eligible if...** - You are between 18 and 70 years old - Your cancer has been confirmed by biopsy as esophageal squamous cell carcinoma - Your cancer progressed after one prior standard treatment (platinum + fluorouracil or taxane combined with immunotherapy) - You have at least one measurable tumor - Your physical performance is good (ECOG 0-1) - Your expected survival is more than 3 months - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - You have had more than one prior line of treatment for advanced disease - You have active uncontrolled brain metastases - You have severe heart, liver, or kidney problems - You are pregnant or breastfeeding - You have had prior treatment with simmitinib or irinotecan Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGsimmitinib plus irinotecan liposome

simmitinib plus irinotecan liposome 70 mg/m\^2 every 2 weeks

DRUGirinotecan liposome

irinotecan liposome 70 mg/m\^2 every 2 weeks

DRUGirinotecan

irinotecan 180mg/m\^2 every 2 weeks


Locations(1)

Harbin Medical University Cancer Hospital

Heilongjiang, Harbin, China

View Full Details on ClinicalTrials.gov

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NCT06512428


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