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

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Open Single Arm Exploratory Study of Apatinib Mesylate Tablets in Combination With Raltitrexed Treatment in Patients With Advanced Colorectal Cancer

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: raltitrexed combined with apatinib


Participation Criteria
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Eligibility Criteria
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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: 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%; 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);

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: raltitrexed combined with apatinib<br>therapeutic regimen : raltitrexed, 3 mg/㎡, ivgtt, d1, apatinib 500 mg, QD po, d1-21, Every 3 weeks for 1 cycles. | Drug: raltitrexed combined with apatinib<br>* raltitrexed, 3 mg/㎡, ivgtt, d1, apatinib 500 mg, QD po, d1-21, Every 3 weeks for 1 cycles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression-free survival progression-free survival | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | overall survival | 12 months | 
| ORR | Objective Response Rate | 12 months | 
| DCR | Disease Control Rate | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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third-line treatment, apatinib, raltitrexed