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

NCT03387904 | Unknown Phase 2

• 1 other identifier: ALTN-11-II-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

Anlotinib

Outcome Measures

Primary Outcomes (2)

• Progress free survival (PFS)

  PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm.

  up to 24 months

• Disease Control Rate (DCR)

  The proportion of patients with a best overall response of confirmed complete or partial response, or stable disease (CR \+ PR + SD)

  up to 24 months

Secondary Outcomes (5)

• Overall Survival (OS)

  up to 24 months

• Objective Response Rate (ORR)

  up to 24 months

• Quality of life score

  up to 24 months

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  up to 24 months

• NGS(Next Generation Sequencing) detecting

  up to 12 months

Study Arms (2)

Anlotinib Plus Irinotecan

EXPERIMENTAL

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

Drug: Anlotinib Plus Irinotecan

Irinotecan

ACTIVE COMPARATOR

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

Drug: Irinotecan

Interventions

Anlotinib Plus Irinotecan DRUG

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

Anlotinib Plus Irinotecan

Irinotecan DRUG

Irinotecan Day 1,8 ivgtt

Irinotecan

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological documentation of esophageal squamous cell carcinoma;
• At least one measurable lesion (by RECIST1.1);
• Patients who have failed to a chemoradiation treatment;
• ，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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

anlotinib; Irinotecan

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Feng Wang, doctor

  The First Affiliated Hospital of Zhengzhou University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng Wang, doctor

CONTACT

860013938244776; fengw010@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: December 23, 2017
• First Posted: January 2, 2018
• Study Start: January 13, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: September 2, 2021

Record last verified: 2021-08

Locations

CN (1)