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Clinical study on the efficacy and safety of bevacizumab combined with TAS-102 in the second-line treatment of advanced colorectal cancer

Clinical study on the efficacy and safety of bevacizumab combined with trifluridine and tippiridine in the second-line treatment of advanced colorectal cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058610
Enrollment
Unknown
Registered
2022-04-12
Start date
2022-04-01
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

colorectal cancer

Interventions

test group:Bevacizumab in combination with TAS-102

Sponsors

Xuchang Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Colorectal cancer patients aged>18 years and= 12 weeks: 5. If the main organs function normally, they meet the following standards: 1) The blood routine examination standard should meet: ANC>1.5x109/L; PLT>90x109/L; Hb>90g/L (no blood transfusion within 14 days); 2) Biochemical examination shall meet the following standards: ALB>30g/L: (no ALB transfusion within 14 days); TBIL50mL/min (CockcrofGault formula); 3) Color Doppler echocardiography and echocardiography: left ventricular ejection fraction (LVEF>55%); 4) 18 lead ECG Fridericia corrected OT interval (OTcF)<470ms in women; 6. Female patients without menopause or surgical sterilization; During the treatment period and at least 7 months after the last administration in the study treatment, consent to abstinence or use of effective contraceptive methods; 7. Willing to join the study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients who have received standard second-line treatment; 2. At the same time, they received anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphate therapy or immunotherapy; 3. In the first 4 weeks of enrollment, he had undergone major surgical procedures unrelated to colorectal cancer. Or the patient has not fully recovered from such surgical procedures; 4. Serious heart disease or discomfort, including but not limited to the following diseases: 1) History of diagnosis of heart failure or systolic dysfunction (LVEF100bpm, significant ventricular arrhythmia (such as ventricular tachycardia) or higher grade atrioventricular block (i.e. Mobitz ? second degree atrioventricular block or third degree atrioventricular block); 3) Angina pectoris requiring anti angina drugs; 4) Valvular heart disease with clinical significance; 5) ECG showed transmural myocardial infarction; 6) Hypertension was poorly controlled (systolic blood pressure>180mmHg and/or diastolic blood pressure>100mmHg). 5. Inability to swallow, intestinal obstruction or other factors affecting drug administration and absorption; 6. People known to have a history of allergy to the drug components of this protocol: have a history of immune deficiency, including HIV positive test, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation; 7. Women in pregnancy and lactation, women with fertility and positive baseline pregnancy test, or women in childbearing age who are unwilling to take effective contraceptive measures during the whole trial period and within 7 months after the last study drug use; 8. Suffer from serious concomitant diseases or other concomitant diseases that will interfere with the planned treatment, or any other circumstances that the investigator believes the patient is not suitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
Progression Free Survival (PFS);

Countries

China

Contacts

Public ContactWang Bin

Xuchang Central Hospital

13137408060@163.com+86 13137408060

Outcome results

None listed

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