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New treatment option for Advanced Esophageal Squamous Cell Carcinoma
Official title A Study of Simmitinib Plus Irinotecan in Advanced Esophageal Squamous Cell Carcinoma
ClinicalTrials.gov ID: NCT06512428
What this study is testing
What is simmitinib plus irinotecan liposome?
simmitinib plus irinotecan liposome is an investigational medicine, being studied as a potential treatment for advanced esophageal squamous cell carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
- At least one measurable lesion according to RECIST 1.1;
You likely can't join if
- 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...
- Prior systemic treatment with anti-VEGF drugs, irinotecan, or any other topoisomerase I inhibitor
- LVEF \<50%；
- BMI≤18.5 kg/m\^2
- Symptomatic central nervous system (CNS) metastases or meningeal metastases;
See the full eligibility criteria
- 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...
- 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) ≤...
- 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.
- 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%；
- BMI≤18.5 kg/m\^2
- Symptomatic central nervous system (CNS) metastases or meningeal metastases;
- 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...
- Patients with bleeding tendency; active bleeding or a history of heavy bleeding within the past 6 months;
- Urine protein ≥ ++ and 24 h urine protein \> 1.0g at screening period;
- Presence of any severe and/or uncontrolled disease before starting treatment;
- Severe lung disease within 6 months before first dosing ；
- Any active infection requiring antibiotics or hormones systemic treatment by intravenous infusion within 14 days prior to the first dose;
- Inability to swallow drugs orally, or presence of clinically significant gastrointestinal disorders
The study team makes the final eligibility decision.
Where it's taking place
- Heilongjiang, Harbin, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Heilongjiang, Harbin, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.