A Study of Simmitinib Plus Irinotecan in Advanced Esophageal Squamous Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorShanghai Runshi Pharmaceutical Technology Co., Ltd
About this trial
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 criteria
Qualifiers
Have fully understood and voluntarily sign the ICF for this study;
Age of 18-70 years (inclusive), male or female;
Esophageal squamous cell carcinoma confirmed histologically or cytologically
Second-line patients with disease progression after only first-line standard therapy（Standard treatment: chemotherapy with platinum plus fluorouracil or taxane combined with immunosuppressive regimen .Progression during adjuvant/neoadjuvant therapy or within 6 months of the last dose is considered a first-line standard treatment failure）
Disqualifiers
Patients who have previously received any anti-tumor therapy within 4 weeks prior to the first dose;
Patients who have previously received any live attenuated vaccine within 4 weeks before the first use of the study treatment or are expected to received any live attenuated vaccine during the study;
Prior systemic treatment with anti-VEGF drugs, irinotecan, or any other topoisomerase I inhibitor
LVEF <50%；
Trial design
Treatments tested in this trial
- simmitinib plus irinotecan liposome
- irinotecan liposome
- irinotecan
Treatment groups
138 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov