search
Back to results

Apatinib in Refractory Colorectal Cancer

Primary Purpose

Colorectal Neoplasms

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
apatinib
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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  • Subjects who have withdrawn from standard treatment due to unacceptable toxicity and precluding retreatment with the same agent prior to progression of disease will also be allowed.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.

Sites / Locations

  • the second hospital of Changzhou city
  • Nanjing 81 Hospital
  • the first affiliated hospital with Nanjing Medical University
  • Jiangnan University affiliated hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

drug,apatinib

Arm Description

apatinib 500mg/qd, 28d/cycle

Outcomes

Primary Outcome Measures

Progression-free Survival(PFS)
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.

Secondary Outcome Measures

Overall Survival (OS)
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.
Disease control rate (DCR)
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)
Objective response rate(ORR)
The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR)
Quality of life
The general well-being of participants, outlining negative and positive features of life.
relationship between the tumor molecular burden & gene mutation and the drug efficacy.
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 .
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
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.

Full Information

First Posted
March 1, 2017
Last Updated
January 12, 2020
Sponsor
The First Affiliated Hospital with Nanjing Medical University
Collaborators
Jiangsu HengRui Medicine Co., Ltd., Beijing gene plus technology co., LTD
search

1. Study Identification

Unique Protocol Identification Number
NCT03190616
Brief Title
Apatinib in Refractory Colorectal Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University
Collaborators
Jiangsu HengRui Medicine Co., Ltd., Beijing gene plus technology co., LTD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
drug,apatinib
Arm Type
Experimental
Arm Description
apatinib 500mg/qd, 28d/cycle
Intervention Type
Drug
Intervention Name(s)
apatinib
Other Intervention Name(s)
YN968D1
Intervention Description
apatinib 500mg/qd, 28d/cycle
Primary Outcome Measure Information:
Title
Progression-free Survival(PFS)
Description
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.
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
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
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.
Time Frame
From assignment of the first subject until 40 death events observed, up to 2 years.
Title
Disease control rate (DCR)
Description
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)
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
Title
Objective response rate(ORR)
Description
The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR)
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
Title
Quality of life
Description
The general well-being of participants, outlining negative and positive features 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
Title
relationship between the tumor molecular burden & gene mutation and the drug efficacy.
Description
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 .
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.
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanhong Gu, Dr.
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
the second hospital of Changzhou city
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213000
Country
China
Facility Name
Nanjing 81 Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Facility Name
the first affiliated hospital with Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
Jiangnan University affiliated hospital
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26884585
Citation
Li J, Qin S, Xu J, Xiong J, Wu C, Bai Y, Liu W, Tong J, Liu Y, Xu R, Wang Z, Wang Q, Ouyang X, Yang Y, Ba Y, Liang J, Lin X, Luo D, Zheng R, Wang X, Sun G, Wang L, Zheng L, Guo H, Wu J, Xu N, Yang J, Zhang H, Cheng Y, Wang N, Chen L, Fan Z, Sun P, Yu H. Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Apatinib in Patients With Chemotherapy-Refractory Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction. J Clin Oncol. 2016 May 1;34(13):1448-54. doi: 10.1200/JCO.2015.63.5995. Epub 2016 Feb 16.
Results Reference
background
PubMed Identifier
23918952
Citation
Li J, Qin S, Xu J, Guo W, Xiong J, Bai Y, Sun G, Yang Y, Wang L, Xu N, Cheng Y, Wang Z, Zheng L, Tao M, Zhu X, Ji D, Liu X, Yu H. Apatinib for chemotherapy-refractory advanced metastatic gastric cancer: results from a randomized, placebo-controlled, parallel-arm, phase II trial. J Clin Oncol. 2013 Sep 10;31(26):3219-25. doi: 10.1200/JCO.2013.48.8585. Epub 2013 Aug 5.
Results Reference
background

Learn more about this trial

Apatinib in Refractory Colorectal Cancer

We'll reach out to this number within 24 hrs