Combining simmitinib with irinotecan for advanced esophageal cancer

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

This study is testing if combining simmitinib with irinotecan can help people with advanced esophageal cancer feel better and improve their treatment outcomes.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 138 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Shanghai Runshi Pharmaceutical Technology Co., Ltd (Industry-sponsored)
• Drugs / interventions: chemotherapy, simmitinib
• Locations: 1 site (Heilongjiang, Harbin)
• Trial ID: NCT06512428 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of simmitinib combined with irinotecan liposome in patients with advanced esophageal squamous cell carcinoma. It consists of two stages: an initial dose escalation phase to determine the maximum tolerated dose (MTD) and a subsequent randomized controlled phase where participants are assigned to one of three treatment groups. The study also aims to assess the pharmacokinetics of the drugs and the relationship between biomarkers and clinical outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with histologically confirmed advanced esophageal squamous cell carcinoma who have experienced disease progression after first-line treatment.

Not a fit: Patients who have not received first-line therapy or those with other types of esophageal cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced esophageal squamous cell carcinoma who have not responded to first-line therapies.

How similar studies have performed: While the combination of simmitinib and irinotecan is being explored, similar approaches in treating advanced esophageal cancer have shown promise, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Have fully understood and voluntarily sign the ICF for this study;
2. Age of 18-70 years (inclusive), male or female;
3. Esophageal squamous cell carcinoma confirmed histologically or cytologically
4. 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）
5. At least one measurable lesion according to RECIST 1.1;
6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1;
7. Expected survival is more than 3 months
8. 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;
9. 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.

Exclusion Criteria

1. Patients who have previously received any anti-tumor therapy within 4 weeks prior to the first dose;
2. 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;
3. Prior systemic treatment with anti-VEGF drugs, irinotecan, or any other topoisomerase I inhibitor
4. LVEF \<50%；
5. BMI≤18.5 kg/m\^2
6. Symptomatic central nervous system (CNS) metastases or meningeal metastases;
7. Patients with other types of malignant tumors within 5 years prior to the screening, except for radically resected, non-recurrent skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical cancer in situ, or other carcinoma in situ;
8. Patients with bleeding tendency; active bleeding or a history of heavy bleeding within the past 6 months;
9. Urine protein ≥ ++ and 24 h urine protein \> 1.0g at screening period;
10. Presence of any severe and/or uncontrolled disease before starting treatment;
11. Severe lung disease within 6 months before first dosing ；
12. Any active infection requiring antibiotics or hormones systemic treatment by intravenous infusion within 14 days prior to the first dose;
13. Inability to swallow drugs orally, or presence of clinically significant gastrointestinal disorders

Where this trial is running

Heilongjiang, Harbin

• Harbin Medical University Cancer Hospital — Heilongjiang, Harbin, China (Recruiting)

Study contacts

• Principal investigator: Yanqiao Zhang, Ph.D — The Second Affiliated Hospital of Harbin Medical University
• Study coordinator: Clinical Trials Information Group officer

Conditions Advanced Esophageal Squamous Cell Carcinoma