A Study of Apatinib in Combination With Raltitrexed Treatment in Patients With Advanced Colorectal Cancer
An Open Single Arm Exploratory Study of Apatinib Mesylate Tablets in Combination With Raltitrexed Treatment in Patients With Advanced Colorectal Cancer
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 colorectal-cancer
Started Jul 2017
Shorter than P25 for phase_2 colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2017
CompletedFirst Submitted
Initial submission to the registry
October 31, 2017
CompletedFirst Posted
Study publicly available on registry
November 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedNovember 17, 2017
October 1, 2017
1.5 years
October 31, 2017
November 13, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PFS
Progression-free survival progression-free survival
6 months
Secondary Outcomes (3)
OS
12 months
ORR
12 months
DCR
12 months
Study Arms (1)
raltitrexed combined with apatinib
EXPERIMENTALtherapeutic regimen : raltitrexed, 3 mg/㎡, ivgtt, d1, apatinib 500 mg, QD po, d1-21, Every 3 weeks for 1 cycles.
Interventions
raltitrexed, 3 mg/㎡, ivgtt, d1, apatinib 500 mg, QD po, d1-21, Every 3 weeks for 1 cycles
Eligibility Criteria
You may qualify if:
- Male or female, ≥ 18 of age;
- Histological confirmed advanced colorectal adenocarcinoma，and at least one measurable lesion;
- Have failed for ≥ 2 lines of standard chemotherapy(included Fluorouracil, irinotecan and oxaliplatin);
- ECOG performance status 0-2;
- Life expectancy of more than 3 months;
- 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%;
- No serious heart, lung, liver, kidney dysfunction; no jaundice and gastrointestinal obstruction; no acute infection;
- Signed informed consent;
- Good compliance, and family members agree to receive survival follow-up.
You may not qualify if:
- Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chinese PLA General Hospital (301 Military Hospital)
Beijing, Beijing Municipality, 100853, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Haiyan Si, M.D.
Chinese PLA General Hospital (301 Military Hospital)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department Director,M.D.
Study Record Dates
First Submitted
October 31, 2017
First Posted
November 17, 2017
Study Start
July 1, 2017
Primary Completion
January 1, 2019
Study Completion
July 1, 2019
Last Updated
November 17, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share