Status:
UNKNOWN
A Study of Apatinib in Combination With Raltitrexed Treatment in Patients With Advanced Colorectal Cancer
Lead Sponsor:
Chinese PLA General Hospital
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
Key Trial Info
Start Date :
July 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03344614
Start Date
July 1 2017
End Date
July 1 2019
Last Update
November 17 2017
Active Locations (1)
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1
Chinese PLA General Hospital (301 Military Hospital)
Beijing, Beijing Municipality, China, 100853