Clinical trial NCT03387904: Study of Anlotinib Plus Irinotecan in Patients With Esophageal Squamous Cell Carcinoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Esophageal Squamous Cell Carcinoma
Keywords: Anlotinib
Lead sponsor: The First Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2018-01-02
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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, 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.

Eligibility 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;

Primary outcomes:
measure: Progress free survival (PFS)
timeFrame: up to 24 months
measure: Disease Control Rate (DCR)
timeFrame: up to 24 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: up to 24 months
measure: Objective Response Rate (ORR)
timeFrame: up to 24 months
measure: Quality of life score
timeFrame: up to 24 months
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: up to 24 months
measure: NGS(Next Generation Sequencing) detecting
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
Study officials:
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Feng Wang, doctor
role: PRINCIPAL_INVESTIGATOR
References: