A Study of Apatinib in Combination With Raltitrexed Treatment in Patients With Advanced Colorectal Cancer

• Status: Unknown status
• Trial end date: 2019-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese PLA General Hospital
• Treatments: Apatinib; Raltitrexed

Criteria

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);