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

C

Chinese PLA General Hospital (301 Hospital)

Status and phase

Unknown
Phase 2

Conditions

Colorectal Cancer

Treatments

Drug: raltitrexed combined with apatinib

Study type

Interventional

Funder types

Other

Identifiers

NCT03344614
AHEAD-311

Details and patient eligibility

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

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy 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:

  • 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);

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

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

Trial contacts and locations

0

Loading...

Central trial contact

Guanghai Dai, M.D.; Haiyan Si, M.D.

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems