Back to resultsA Study of Apatinib in Combination With Raltitrexed Treatment in Patients With Advanced Colorectal Cancer
Primary Purpose
Colorectal Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
raltitrexed combined with apatinib
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring third-line treatment, apatinib, raltitrexed
Eligibility Criteria
Inclusion Criteria:
- 1.Male or female, ≥ 18 of age;
- 2.Histological confirmed advanced colorectal adenocarcinoma，and at least one measurable lesion;
- 3.Have failed for ≥ 2 lines of standard chemotherapy(included Fluorouracil, irinotecan and oxaliplatin);
- 4.ECOG performance status 0-2;
- 5.Life expectancy of more than 3 months;
6.The main organs function is well, and randomized within 14 days before the relevant inspection indicators to meet the following requirements:
- blood routine test Hgb ﹥90g/L, ANC﹥1.5×109/L, Platelets ﹥ 100×109/L,
- biochemical tests Serum Total bilirubin ≤ 1.5 X UNL(upper normal limit), ALT or AST ≤ 2 xUNL, and ﹤ 5 x UNL（Hematogenous metastases）, Creatinine clearance rate≥ 60 ml/min(Cockcroft-Gault formula),
- Doppler echocardiography assessment：LVEF ≥ 50%;
- 7.No serious heart, lung, liver, kidney dysfunction; no jaundice and gastrointestinal obstruction; no acute infection;
- 8.Signed informed consent;
- 9.Good compliance, and family members agree to receive survival follow-up.
Exclusion Criteria:
- 1.Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
Sites / Locations
- Chinese PLA General Hospital (301 Military Hospital)Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
raltitrexed combined with apatinib
Arm Description
therapeutic regimen : raltitrexed, 3 mg/㎡, ivgtt, d1, apatinib 500 mg, QD po, d1-21, Every 3 weeks for 1 cycles.
Outcomes
Primary Outcome Measures
PFS
Progression-free survival progression-free survival
Secondary Outcome Measures
OS
overall survival
ORR
Objective Response Rate
DCR
Disease Control Rate
Full Information
NCT ID
NCT03344614
First Posted
October 31, 2017
Last Updated
November 13, 2017
Sponsor
Chinese PLA General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03344614
Brief Title
A Study of Apatinib in Combination With Raltitrexed Treatment in Patients With Advanced Colorectal Cancer
Official Title
An Open Single Arm Exploratory Study of Apatinib Mesylate Tablets in Combination With Raltitrexed Treatment in Patients With Advanced Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
January 1, 2019 (Anticipated)
Study Completion Date
July 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
30 patients with advanced colorectal cancer will be enrolled to observe the efficacy and safety of raltitrexed combined with apatinib as a third-line treatment.
Detailed Description
In this study, we plan to enroll 30 patients with advanced colorectal cancer after failure of second-line standard chemotherapy. The therapeutic regimen is raltitrexed, 3 mg/㎡, ivgtt, d1, apatinib 500 mg, qd,po, d1-21, Every 3 weeks for 1 cycles, the primary end point was PFS, the secondary end point was OS, DCR, ORR etc. Aim to observe the efficacy and safety of raltitrexed combined with apatinib as a third-line treatment of in patients with advanced colorectal cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
third-line treatment, apatinib, raltitrexed
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
raltitrexed combined with apatinib
Arm Type
Experimental
Arm Description
therapeutic regimen : raltitrexed, 3 mg/㎡, ivgtt, d1, apatinib 500 mg, QD po, d1-21, Every 3 weeks for 1 cycles.
Intervention Type
Drug
Intervention Name(s)
raltitrexed combined with apatinib
Intervention Description
raltitrexed, 3 mg/㎡, ivgtt, d1, apatinib 500 mg, QD po, d1-21, Every 3 weeks for 1 cycles
Primary Outcome Measure Information:
Title
PFS
Description
Progression-free survival progression-free survival
Time Frame
6 months
Secondary Outcome Measure Information:
Title
OS
Description
overall survival
Time Frame
12 months
Title
ORR
Description
Objective Response Rate
Time Frame
12 months
Title
DCR
Description
Disease Control Rate
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1.Male or female, ≥ 18 of age;
2.Histological confirmed advanced colorectal adenocarcinoma，and at least one measurable lesion;
3.Have failed for ≥ 2 lines of standard chemotherapy(included Fluorouracil, irinotecan and oxaliplatin);
4.ECOG performance status 0-2;
5.Life expectancy of more than 3 months;
6.The main organs function is well, and randomized within 14 days before the relevant inspection indicators to meet the following requirements:
blood routine test Hgb ﹥90g/L, ANC﹥1.5×109/L, Platelets ﹥ 100×109/L,
biochemical tests Serum Total bilirubin ≤ 1.5 X UNL(upper normal limit), ALT or AST ≤ 2 xUNL, and ﹤ 5 x UNL（Hematogenous metastases）, Creatinine clearance rate≥ 60 ml/min(Cockcroft-Gault formula),
Doppler echocardiography assessment：LVEF ≥ 50%;
7.No serious heart, lung, liver, kidney dysfunction; no jaundice and gastrointestinal obstruction; no acute infection;
8.Signed informed consent;
9.Good compliance, and family members agree to receive survival follow-up.
Exclusion Criteria:
1.Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haiyan Si, M.D.
Phone
+8613911070673
Email
sihaiyan2008@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Guanghai Dai, M.D.
Phone
+8613801232381
Email
daigh301@vip.sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haiyan Si, M.D.
Organizational Affiliation
Chinese PLA General Hospital (301 Military Hospital)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese PLA General Hospital (301 Military Hospital)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haiyan Si, M.D.
Phone
+8613911070673
Email
sihaiyan2008@sina.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of Apatinib in Combination With Raltitrexed Treatment in Patients With Advanced Colorectal Cancer
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