Apatinib in Refractory Colorectal Cancer

January 12, 2020 updated by: Gu Yanhong, The First Affiliated Hospital with Nanjing Medical University

A Single Arm, Open Label, Multicenter Exploratory Study of Apatinib in Patients With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Second Line Therapy

Limited agents have been approved after standard first and second line treatment. Regorafenib and Trifluridine/Tipiracil (TAS-102) are still not approved in China.Apatinib has shown significant efficacy in refractory advanced gastric cancer regarding PFS and OS with controllable toxicity.This study is aimed to explore the efficacy,safety as well as predictive biomarker in advanced colorectal cancer failed to standard therapy in Chinese population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Changzhou, Jiangsu, China, 213000
        • the second hospital of Changzhou city
      • Nanjing, Jiangsu, China, 210029
        • The First Affiliated Hospital with Nanjing Medical University
      • Nanjing, Jiangsu, China, 210000
        • Nanjing 81 Hospital
      • Wuxi, Jiangsu, China, 214000
        • Jiangnan University affiliated hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histological or cytological documentation of adenocarcinoma of the colon or rectum. All other histological types are excluded.
  • Subjects with metastatic colorectal cancer(CRC) (Stage IV).
  • Subjects must have failed at least two lines of prior treatment, which must include a fluoropyrimidine, oxaliplatin and irinotecan.
  • Subjects treated with oxaliplatin in an adjuvant setting should have progressed during or within 6 months of completion of adjuvant therapy.
  • Subjects who have withdrawn from standard treatment due to unacceptable toxicity and precluding retreatment with the same agent prior to progression of disease will also be allowed.
  • Prior treatment with bevacizumab and/or cetuximab will be allowed.
  • Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1.is necessary.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
  • Life expectancy of at least 3 months.
  • Adequate bone marrow, liver and renal function as assessed by the laboratory required by protocol.
  • assigned informed consent.

Exclusion Criteria:

  • Previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)].
  • Participants of other clinical trial within 4 weeks.
  • Diseases which will impact the absorption of apatinib, eg. dysphagia, chronic diarrhea, bowl obstruction
  • Hemorrhage events of ≥grade 3 within 4 weeks.
  • known central nervous system metastasis.
  • Uncontrolled hypertension. (Systolic blood pressure 140 mmHg or diastolic pressure 90 mmHg despite optimal medical management). Unstable angina,congestive heart failure,Myocardial infarction, Cardiac arrhythmias requiring anti-arrhythmic therapy.
  • urine protein ≥++ and 24h urine protein more than 1.0g.
  • Chronically green wound or bone fracture.
  • Arterial or venous thrombotic or embolic events.
  • Tumor invading important blood vessel with high risk of severe hemorrhage.
  • Abnormal coagulation function.
  • thromboemboli events within 6 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: drug,apatinib
apatinib 500mg/qd, 28d/cycle
Drug: apatinib
apatinib 500mg/qd, 28d/cycle
Other Names:
  • YN968D1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival(PFS)
Time Frame: From assignment of the first subject to 3 months later after the last participant is recruited.The last participant will be recruited before Mar 30,2019
PFS was defined as the time from assignment to disease progression radiological/clinical or death due to any cause, whichever occurs first. Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation.
From assignment of the first subject to 3 months later after the last participant is recruited.The last participant will be recruited before Mar 30,2019

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: From assignment of the first subject until 40 death events observed, up to 2 years.
OS is defined as the time from date of assignment to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.
From assignment of the first subject until 40 death events observed, up to 2 years.
Disease control rate (DCR)
Time Frame: From assignment of the first subject to 3 months later after the last participant is recruited.The last participant will be recruited before Mar 30,2019
DCR is defined as the percentage of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD)
From assignment of the first subject to 3 months later after the last participant is recruited.The last participant will be recruited before Mar 30,2019
Objective response rate(ORR)
Time Frame: From assignment of the first subject to 3 months later after the last participant is recruited.The last participant will be recruited before Mar 30,2019
The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR)
From assignment of the first subject to 3 months later after the last participant is recruited.The last participant will be recruited before Mar 30,2019
Quality of life
Time Frame: From assignment of the first subject to 3 months later after the last participant is recruited.The last participant will be recruited before Mar 30,2019
The general well-being of participants, outlining negative and positive features of life.
From assignment of the first subject to 3 months later after the last participant is recruited.The last participant will be recruited before Mar 30,2019
relationship between the tumor molecular burden & gene mutation and the drug efficacy.
Time Frame: From assignment of the first subject to 3 months later after the last participant is recruited.The last participant will be recruited before Mar 30,2019.
The tumor molecular clones and gene mutations of 1021 tumor related genes will be detected by next-generation sequencing,which will be matched with the CT scanning .
From assignment of the first subject to 3 months later after the last participant is recruited.The last participant will be recruited before Mar 30,2019.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: From assignment of the first subject to 3 months later after the last participant is recruited.The last participant will be recruited before Mar 30,2019.
adverse events will be assessed according to CTCAE v4.0, including hematological and non-hematological adverse events. Non-hematological adverse events will be collected by patients reported outcomes questionaire. The adverse events of interest include hypertension,hand-foot syndrome,proteinuria,hoarseness,rash,etc.The dose reduction and drug discontinuance due to adverse events will also be recorded.
From assignment of the first subject to 3 months later after the last participant is recruited.The last participant will be recruited before Mar 30,2019.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Collaborators

Jiangsu HengRui Medicine Co., Ltd.
Beijing gene plus technology co., LTD

Investigators

  • Principal Investigator: Yanhong Gu, Dr., The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2017

Primary Completion (Actual)

June 30, 2019

Study Completion (Actual)

December 30, 2019

Study Registration Dates

First Submitted

March 1, 2017

First Submitted That Met QC Criteria

June 14, 2017

First Posted (Actual)

June 19, 2017

Study Record Updates

Last Update Posted (Actual)

January 14, 2020

Last Update Submitted That Met QC Criteria

January 12, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEEP-G 01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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