Colorectal Cancer
Conditions
Keywords
third-line treatment, apatinib, raltitrexed
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.
Interventions
DRUGraltitrexed combined with apatinib
raltitrexed, 3 mg/㎡, ivgtt, d1, apatinib 500 mg, QD po, d1-21, Every 3 weeks for 1 cycles
Sponsors
Chinese PLA General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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: 1. blood routine test Hgb ﹥90g/L, ANC﹥1.5×109/L, Platelets ﹥ 100×109/L, 2. 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), 3. 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);
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 6 months | Progression-free survival progression-free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | 12 months | overall survival |
| ORR | 12 months | Objective Response Rate |
| DCR | 12 months | Disease Control Rate |
Countries
China
Contacts
Primary ContactHaiyan Si, M.D.
Backup ContactGuanghai Dai, M.D.
Outcome results
None listed