Status and phase
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About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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:
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
Primary purpose
Allocation
Interventional model
Masking
30 participants in 1 patient group
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Central trial contact
Guanghai Dai, M.D.; Haiyan Si, M.D.
Data sourced from clinicaltrials.gov
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