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Trial Title:
A Study of Simmitinib Plus Irinotecan in Advanced Esophageal Squamous Cell Carcinoma
NCT ID:
NCT06512428
Condition:
Advanced Esophageal Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Irinotecan
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Intervention model description:
Dose Escalation Phase:
Dose 1: simmitinib 4mg QD plus irinotecan liposome 70 mg/m^2 every 2 weeks; Dose 2:
simmitinib 6mg 3 weeks on 1 week off plus irinotecan liposome 70 mg/m^2 every 2 weeks;
Dose 3: simmitinib 6mg QD plus irinotecan liposome 70 mg/m^2 every 2 weeks;
Randomized controlled study Phase:
Randomly assigned to the following 3 groups at 1:1:1 ratio, including simmitinib plus
irinotecan liposome, irinotecan liposome, and irinotecan.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
simmitinib plus irinotecan liposome
Description:
simmitinib plus irinotecan liposome 70 mg/m^2 every 2 weeks
Arm group label:
simmitinib plus irinotecan liposome
Intervention type:
Drug
Intervention name:
irinotecan liposome
Description:
irinotecan liposome 70 mg/m^2 every 2 weeks
Arm group label:
irinotecan liposome
Intervention type:
Drug
Intervention name:
irinotecan
Description:
irinotecan 180mg/m^2 every 2 weeks
Arm group label:
irinotecan
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.
Detailed description:
The experiment was divided into two stages. The first stage is dose escalation stage.
Rapid titration and "3+3" dose escalation design were used to observe DLT of simmitinib
plus irinotecan liposome, and MTD was determined. The second stage is a randomized
controlled study. After RP2D was determined in the first stage, participants were
randomly assigned to 3 groups in a 1:1:1 ratio, including simmitinib plus irinotecan
liposome, irinotecan liposome, and irinotecan.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Harbin Medical University Cancer Hospital
Address:
City:
Heilongjiang
Zip:
150076
Country:
China
Status:
Recruiting
Contact:
Last name:
Yanqiao Zhang, Ph.D
Phone:
0451-86298222
Email:
yanqiaozhanggcp@163.com
Start date:
March 15, 2024
Completion date:
January 30, 2026
Lead sponsor:
Agency:
Shanghai Runshi Pharmaceutical Technology Co., Ltd
Agency class:
Industry
Source:
Shanghai Runshi Pharmaceutical Technology Co., Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06512428
