Efficacy exploration of 2nd line in advanced colorectal cancer

Efficacy and Biomarker exploration of 2nd line Aflibercept in combination with FOLFIRI in advanced colorectal cancer

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0004757

Enrollment

153

Registered

2020-02-21

Start date

2020-05-21

Completion date

Unknown

Last updated

2021-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Registry study Day 1. Aflibercept + FOLFIRI • aflibercept(Zaltrap): 4 mg/kg IV infusion for over 1hr (Do not administer as an IV push or bolus) • Leucovorin: 400 mg/m2 IV infusion for over 2

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patient is an adult, = 19 years old at the time of informed consent 2) Patient has histologically confirmed advanced adenocarcinoma of colon or rectum 3) Patients who were failed in only one treatment with target agent (anti-EGFR Ab or anti-VEGF Ab) combined with FOLFOX 4) At least one measurable disease, as defined by RECIST version 1.1 5) ECOG PS of 0 to 2. 6) Life expectancy = 3 months. 7) Acceptable hematologic status (without growth factor support or transfusion dependency): a. ANC ?1.5 x 109/L, b. Platelet count ?100 x 109/L c. Hemoglobin ?9.0 g/dL. 8) Acceptable liver function: a. Bilirubin = 1.0 x upper limit of normal(ULN) b. AST, ALT = 2.5 x ULN or = 5.0 x ULN in case of liver metastasis 9) Serum creatinine = 1.0 x UNL 10) Patients who understand study protocol and signed informed consents.

Exclusion criteria

Exclusion criteria: 1) Previous therapy with other VEGFR inhibitors (other than bevacizumab) or irinotecan 2) Patients who have serious underlying co-morbidities which could cause end-organ dysfunction, interfere with the conduct of the study, or that would pose an unacceptable risk to the subject in this study. in the opinion of the Investigator 3) Contraindications to the use of FOLFIRI or aflibercept 4) Female patients who are pregnant or breast feeding, or male/female patients of reproductive potential who are not willing to employ effective birth control

Design outcomes

Primary

Measure	Time frame
Profression free survival	—

Secondary

Measure	Time frame
Overall survival (OS);objective response rate (ORR);safety profile;biomarker study	—

Countries

Korea, Republic of

Contacts

Public ContactHan Sang Kim

Yonsei University Health System, Severance Hospital

MODEERFHS@yuhs.ac+82-2-2228-8134

Outcome results