Study of Anlotinib Plus Irinotecan in Patients With Esophageal Squamous Cell Carcinoma

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To compare the effects and safety of Anlotinib Plus Irinotecan versus Irinotecan in patients with esophageal squamous cell carcinoma(ESCC).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Zhengzhou University
• Treatments: Irinotecan

Criteria

Inclusion Criteria:

• 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 Criteria:

• Allergic to anlotinib and/or its excipients;

• Patients with any severe and/or unable to control diseases，including：

1. Blood pressure unable to be controlled ideally(systolic pressure >140 mmHg，diastolic pressure>90 mmHg);

2. 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;