Status:
UNKNOWN
Study of Anlotinib Plus Irinotecan in Patients With Esophageal Squamous Cell Carcinoma
Lead Sponsor:
The First Affiliated Hospital of Zhengzhou University
Conditions:
Esophageal Squamous Cell Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
To compare the effects and safety of Anlotinib Plus Irinotecan versus Irinotecan in patients with esophageal squamous cell carcinoma(ESCC).
Detailed Description
In recent years, anti-angiogenic therapy has made some progress in the treatment of advanced esophageal squamous cell carcinoma.In clinical use, the efficacy of antiangiogenic monotherapy was low, wit...
Eligibility Criteria
Inclusion
- Histological documentation of esophageal squamous cell carcinoma;
- At least one measurable lesion (by RECIST1.1);
- Patients who have failed to a chemoradiation treatment;
- 18-75，ECOG PS:0-1,Life expectancy of more than 12 weeks;
- No treated with molecular targeted drugs;
- Main organs function is normal;
- Patients should participate in the study voluntarily and sign informed consent;
Exclusion
- Allergic to anlotinib and/or its excipients;
- Patients with any severe and/or unable to control diseases，including：
- Blood pressure unable to be controlled ideally(systolic pressure \>140 mmHg，diastolic pressure\>90 mmHg);
- Patients with Grade 2 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QT≥450ms for male， QT≥470ms for female) and patients with Grade 3 or higher congestive heart failure (NYHA Classification) or LVEF\<50%;
- Patients with a clear Gastrointestinal bleeding tendency include the following situations: Local active ulcer lesions, and fecal occult blood (+ +) ; The patient had a history of black and hematemesis within 2 months;
- Patients with a bleeding tendency and INR\>1.5,APTT\>1.5 ULN ;
- Patients with factors that could affect oral medication (such as dysphagia，chronic diarrhea, intestinal obstruction etc.);
- Patients with active brain metastasis, cancerous meningitis, spinal cord compression patients or found in Screening stage;
- Patients treated with VEGFR inhibitor;
- Patients with drug abuse history and unable to get rid of or Patients with mental disorders;
- Patients participated in other anticancer drug clinical trials within 4 weeks;
- Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment;
Key Trial Info
Start Date :
January 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03387904
Start Date
January 13 2019
End Date
December 1 2022
Last Update
September 2 2021
Active Locations (1)
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1
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052