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

NCT ID: NCT03387904

Last Updated: 2021-09-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-13
• Study Completion Date: 2022-12-01

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.

Conditions

Esophageal Squamous Cell Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Anlotinib Plus Irinotecan

Anlotinib QD po.and Irinotecan Day 1,8 ivgtt. Both should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Group Type: EXPERIMENTAL

Anlotinib Plus Irinotecan

Intervention Type: DRUG

Anlotinib QD po.and Irinotecan Day 1,8 ivgtt.

Irinotecan

Irinotecan Day 1,8 ivgtt and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Group Type: ACTIVE_COMPARATOR

Irinotecan

Intervention Type: DRUG

Irinotecan Day 1,8 ivgtt

Interventions

Anlotinib Plus Irinotecan

Anlotinib QD po.and Irinotecan Day 1,8 ivgtt.

Intervention Type: DRUG

Irinotecan

Irinotecan Day 1,8 ivgtt

Intervention Type: DRUG

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role: lead

Responsible Party

Feng Wang

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Feng Wang, doctor

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Zhengzhou University

Locations

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Feng Wang, doctor

Role: CONTACT

fengw010@163.com

860013938244776

Facility Contacts

Feng Wang, doctor

Role: primary

Qingxia Fan, doctor

Role: backup

Other Identifiers

ALTN-11-II-01

Identifier Type: -

Identifier Source: org_study_id