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

Esophageal Squamous Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03387904
• Other study ID #: ALTN-11-II-01
• Status: Recruiting
• Phase: Phase 2
• Start date: January 13, 2019
• Est. completion date: December 1, 2022

Study information

• Verified date: August 2021
• Source: The First Affiliated Hospital of Zhengzhou University
• Contact: Feng Wang, doctor
• Phone: 860013938244776
• Email: fengw010[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma

Intervention

Drug:
• Anlotinib Plus Irinotecan
Anlotinib QD po.and Irinotecan Day 1,8 ivgtt.
• Irinotecan
Irinotecan Day 1,8 ivgtt

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Zhengzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Overall Survival (OS)	The time from treatment initiation until death from any reason	up to 24 months
Secondary	Objective Response Rate (ORR)	The proportion of patients with a confirmed complete response or partial response on two consecutive occasions=4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1	up to 24 months
Secondary	Quality of life score	Each 42 days up to intolerance the toxicity or PD	up to 24 months
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Until initiation of new anticancer treatment	up to 24 months
Secondary	NGS(Next Generation Sequencing) detecting	The sample for NGS detecting can be gotten form storage tumor tissue specimens. It must be better collecting the new tumor tissue specimens after tumor progress	up to 12 months