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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
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• 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)

• At least one measurable lesion according to RECIST 1.1;

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1;

• Expected survival is more than 3 months

• Adequate organ function, defined as:

• Absolute Neutrophil count (ANC) ≥ 1.5 × 10\^9/L; Platelet count (PLT) ≥ 75× 10\^9/L; Hemoglobin (Hb) ≥ 90 g/L; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN) (≤ 5.0 × ULN for patients with liver metastases); Serum total bilirubin (TBIL) ≤ 1.5 × ULN; Serum creatinine ≤ 1.5 × ULN and Creatinine clearance (CCr)≥60mL/min; Prothrombin time (PT)、activated partial thromboplastin time (APTT)、international normalized ratio(INR)≤1.5 × ULN;

• Male and female patients of childbearing age must agree to take effective contraceptive measures during treatment and within 6 months after the last dose of treatment.

Locations
Other Locations
China
Harbin Medical University Cancer Hospital
RECRUITING
Heilongjiang
Contact Information
Primary
Clinical Trials Information Group officer
ctr-contact@cspc.cn
86-0311-69085587
Time Frame
Start Date: 2024-03-15
Estimated Completion Date: 2026-01-30
Participants
Target number of participants: 138
Treatments
Experimental: simmitinib plus irinotecan liposome
Experimental: irinotecan liposome
Experimental: irinotecan
Related Therapeutic Areas
Sponsors
Leads: Shanghai Runshi Pharmaceutical Technology Co., Ltd

This content was sourced from clinicaltrials.gov

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