- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05636150
A Phase II Clinical Study of Fruquintinib Combined With S-1 for Advanced Esophageal Squamous Cell Carcinoma
A Phase II Clinical Study to Evaluate the Efficacy and Safety of Fuquinitinib Combined With S-1 in the Treatment of Patients With Advanced Esophageal Squamous Cell Carcinoma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Zhao Lin, MD
- Phone Number: 010 69158753
- Email: wz20010727@aliyun.com
Study Contact Backup
- Name: Li Ningning
- Phone Number: 13718886921
Study Locations
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-
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Beijing, China
- Recruiting
- Peking Union Medical College Hospital
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Contact:
- Zhao Lin, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female patients, age:≥18 years old
- Imageology diagnosed with refractory or metastatic esophageal squamous cell carcinoma
- Disease progression after the last dose of the first-line therapy (with immunotherapy, without fluoropyrimidine)
- At least one measurable lesion (RECIST1.1)
- Good performance status Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 to 2
- Life expectancy of more than 12 weeks
- The test value for bone marrow, liver and renal function evaluation within 7 days prior to first dosing should meet requirements
- Negative of blood pregnancy test within 7 days prior to first dosing for fertile female patients. Fertile female and male patients agree to use effective contraceptive methods during the study and within 6 months post to the last dose, such as double barrier contraception, condoms, oral or injection contraceptives, intrauterine devices, abstinence, etc. All female patients will be considered fertile unless the female patient has natural menopause or has undergone artificial menopause or sterilization (hysterectomy, bilateral appendage resection);
- Signed informed consent
Exclusion Criteria:
- Absolute neutrophil count (ANC) <1.5×109/L, platelet count <75×109/L, and hemoglobin <9g/dL
- Serum total bilirubin >1.5× the upper limit of normal (ULN)
- Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) >2.5×ULN
- Creatinine > 1.5 × ULN or creatinine clearance <50 mL/min
- Activated partial thromboplastin time (APTT)> 1.5 × ULN
- The investigators determined clinically significant severe electrolyte abnormalities.
- Proteinuria ≥ 2+ (1.0g/24hr)
- Drug uncontrollable hypertension, defined as systolic blood pressure ≥ 140 mmHg and / or diastolic blood pressure ≥ 90 mmHg
- The patients have active ulcer of stomach and duodenum, ulcerative colitis and other digestive tract diseases or unresectable tumors with active bleeding, or other conditions that may cause gastrointestinal bleeding and perforation, as judged by investigators; or the existence of gastrointestinal perforation or gastrointestinal fistula uncured post to previous surgical treatment
- Patients with evidence or history of propensity to hemorrhage within 2 months prior to first dosing, regardless of severity(such as melena, hematemesis, hemoptysis, bloody stools)
- Arterial thrombosis or deep venous thrombosis within 6 months prior to first dosing, or thromboembolic events
- Cardiovascular diseases of significant clinical significance, including, but not limited to acute myocardial infarction, severe/unstable angina pectoris or coronary artery bypass grafting within 6 months prior to first dosing, congestive heart failure with New York Heart Association (NYHA) grade ≥ 2; Left ventricular ejection fraction (LVEF) < 50%
- Uncontrolled malignant pleural effusion, ascites or pericardial effusion
- Previous treatment with anti-vascular endothelial growth factor receptor (VEGFR) inhibitors
- A history of other malignancies within 5 years prior to inclusion, except for cervical carcinoma in situ, basal or squamous cell skin cancer
- Distal metastasis to brain
- History of clinically significant hepatic disease, including, but not limited to, known hepatitis B virus (HBV) infection with HBV DNA positive (copies ≥1×104/ml); known hepatitis C virus infection with HCV RNA positive
- Women who are pregnant or lactating
- Patients considered unsuitable for inclusion in this study by the investigator
- Patients considered a serious mental or mental abnormality
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fruquintinib plus S-1
Cohort A: Fruquintinib 3 mg QD, oral dosing, 2 weeks on/1 weeks off+ S-1 40-60mg/time bid po d1-14 q3w. Cohort B: Fruquintinib 4 mg QD, oral dosing, 2 weeks on/1 weeks off+ S-1 40-60mg/time bid po d1-14 q3w. Cohort C: Fruquintinib 5 mg QD, oral dosing, 2 weeks on/1 weeks off+ S-1 40-60mg/time bid po d1-14 q3w. |
Cohort A: Fruquintinib 3 mg QD, oral dosing, 2 weeks on/1 weeks off+ S-1 40-60mg/time bid po d1-14 q3w. Cohort B: Fruquintinib 4 mg QD, oral dosing, 2 weeks on/1 weeks off+ S-1 40-60mg/time bid po d1-14 q3w. Cohort C: Fruquintinib 5 mg QD, oral dosing, 2 weeks on/1 weeks off+ S-1 40-60mg/time bid po d1-14 q3w. Patients will be treated until disease progression, death, unacceptable toxicity, loss of follow-up, withdrawal of consent or other conditions meet the end of treatment criteria. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression free survival (PFS)
Time Frame: From date of first dose of study drug until disease progression, withdrawal of consent, death (up to approximately 1 year)
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PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause.
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From date of first dose of study drug until disease progression, withdrawal of consent, death (up to approximately 1 year)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival (OS)
Time Frame: Baseline to measured date of death from any cause (up to approximately 1 year)
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Baseline to measured date of death from any cause (up to approximately 1 year)
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Objective response rate (ORR)
Time Frame: from treatment up to progressive disease or EOT due to any cause up to 1 year
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Tumor assessment will be performed using radiography method every 6 weeks until the occurrence of progressive disease (PD), using RECIST v 1.1
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from treatment up to progressive disease or EOT due to any cause up to 1 year
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Disease control rate (DCR)
Time Frame: from treatment up to progressive disease or EOT due to any cause up to 1 year
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Tumor assessment will be performed using radiography method every 6 weeks until the occurrence of progressive disease (PD), using RECIST v 1.1
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from treatment up to progressive disease or EOT due to any cause up to 1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Zhao Lin, MD, Peking Union Medical College Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Neoplasms, Squamous Cell
- Esophageal Neoplasms
- Carcinoma
- Carcinoma, Squamous Cell
- Esophageal Squamous Cell Carcinoma
Other Study ID Numbers
- 2021-013-CH07 IIT-EC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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