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

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.

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.

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);