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

A Randomized, Eploratory, Open Clinical Trial to Compare the Efficacy and Safety of Anlotinib Plus Irinotecan Versus Irinotecan in Patients With Esophageal Squamous Cell Carcinoma

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

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, with a median progression-free survival (PFS) of only 3 to 4 months.We conducted a randomized, open clinical Trial to evaluate efficacy and safety of anlotinib hydrochloride combined with irinotecan versus irinotecan monotherapy in patients with advanced esophageal squamous cell carcinoma.

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;