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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03344614
• Other study ID #: AHEAD-311
• Status: Recruiting
• Phase: Phase 2
• First received: October 31, 2017
• Last updated: November 13, 2017
• Start date: July 1, 2017
• Est. completion date: July 1, 2019

Study information

• Verified date: October 2017
• Source: Chinese PLA General Hospital
• Contact: Haiyan Si, M.D.
• Phone: +8613911070673
• Email: sihaiyan2008[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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);

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• raltitrexed combined with apatinib
raltitrexed, 3 mg/?, ivgtt, d1, apatinib 500 mg, QD po, d1-21, Every 3 weeks for 1 cycles

Locations

Country	Name	City	State
China	Chinese PLA General Hospital (301 Military Hospital)	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	Progression-free survival progression-free survival	6 months
Secondary	OS	overall survival	12 months
Secondary	ORR	Objective Response Rate	12 months
Secondary	DCR	Disease Control Rate	12 months