The efficacy and safety of regorafenib taking 5 days and stop 2 days for the third-line treatment in mRCR patients

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000032297

Enrollment

Unknown

Registered

2020-04-25

Start date

2020-05-01

Completion date

Unknown

Last updated

2020-04-27

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

Conditions

colorectal cancer

Interventions

experimental group:Regorafenib, taking 5 days and stop 2 days

control group:Regorafenib, once a day

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with advanced colorectal cancer confirmed by pathology; 2. Patients who can only receive two chemotherapy regimens after recurrence or metastasis; 3. Patients who voluntarily sign the informed consent, understand the study and are willing to follow and able to complete all test procedures; 4. Unlimited for men and women, aged 18-70 (including boundary value)years; 5. Patients with ECoG score of 0 or 1; 6. Patients expected to survive for at least 3 months; 7. According to the criteria of solid tumor evaluation (RECIST v1.1), patients with measurable focus (at least one extracranial focus) are required; 8. Subjects whose laboratory examination results within two weeks before enrollment meet the following conditions: Absolute neutrophil count (ANC) >= 1.5 x 10^9 / L; WBC >= 3.0 x 10^9 / L; Platelet >= 90 x 10^9 / L; Hemoglobin >= 90g / L; Serum creatinine <= 1.5 times the upper limit of normal value (ULN); AST and alt <= 2.5 times ULN, liver metastasis <= 5 times ULN; The total bilirubin (TBIL) was less than 1.5 times ULN; International standardized ratio (INR) < 2 times ULN, or activated partial thromboplastin (appt) < 1.5 times ULN (except for patients undergoing anticoagulant treatment). 9. Male subjects and female subjects of childbearing age should agree to take effective contraceptive measures from the signing of informed consent to 3 months after the last administration.

Exclusion criteria

Exclusion criteria: 1. Patients with a clear history of neurological or mental disorders, such as epilepsy, dementia, poor compliance, or peripheral nervous system disorders; 2. pregnant and lactating women; 3. Patients with symptomatic brain metastasis; 4. Subjects who, in the opinion of the researchers, are not suitable for the trial due to other reasons. 5. Subjects with active bleeding symptoms; 6. Subjects with contraindications of regofinib.

Design outcomes

Primary

Measure	Time frame
Progression-Free Survival;	—

Secondary

Measure	Time frame
Overall Survival;disease control rate;Adverse Event Rate;Quality of Life Scale;	—

Countries

China

Contacts

Public ContactYifu He

Anhui Provincial Cancer Hospital

yifuhe@fsyy.ustc.edu.cn+86 18963789042

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026