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

Phase 2

• Conditions: Colorectal Cancer
• Interventions: Drug: raltitrexed combined with apatinib

• Registration Number: NCT03344614
• Lead Sponsor: Chinese PLA General Hospital

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.

Study Timeline

• Study Start: 2017-07-01
• Status Verified: 2017-10
• Study First Submitted: 2017-10-31
• Study First Submitted QC: 2017-11-13
• Last Update Submitted: 2017-11-13
• Study First Posted: 2017-11-17
• Last Update Posted: 2017-11-17
• Primary Completion: 2019-01-01
• Study Completion: 2019-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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);

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
raltitrexed combined with apatinib	raltitrexed combined with apatinib	therapeutic regimen : raltitrexed, 3 mg/㎡, ivgtt, d1, apatinib 500 mg, QD po, d1-21, Every 3 weeks for 1 cycles.

Primary Outcome Measures

Name	Time	Method
PFS	6 months	Progression-free survival progression-free survival

Secondary Outcome Measures

Name	Time	Method
OS	12 months	overall survival
ORR	12 months	Objective Response Rate
DCR	12 months	Disease Control Rate

Trial Locations

Locations (1)

Chinese PLA General Hospital (301 Military Hospital); 🇨🇳 Beijing, Beijing, China