Skip to content

The efficacy and safety study of TAS-102 combined with bevacizumab in first-line or second-line treatment of advanced colorectal cancer patients who are not suitable for intensive therapy

The efficacy and safety study of TAS-102 combined with bevacizumab in first-line or second-line treatment of advanced colorectal cancer patients who are not suitable for intensive therapy

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104067
Enrollment
Unknown
Registered
2025-06-10
Start date
2025-06-15
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Colorectal cancer

Interventions

TAS-102+Bevacizumab regimen for first - and second-line treatment of advanced colorectal cancer patients who are not suitable for aggressive therapy:Bevacizumab 5mg/kg d1, TAS-102 35mg/m2 bid po d1-5,

Sponsors

Yunnan Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Colorectal cancer diagnosed by organizational or cellular pathology; (2) Age >= 18 years old, gender not limited; (3) For those who have not yet received first-line treatment and are deemed unsuitable for intense chemotherapy regimens, such as those aged 70 years or older, with poor physical condition or organ function, and with low tumor burden and slow growth such as lung metastasis, or who have previously received first-line chemotherapy based on fluorouracil, oxaliplatin, or irinotecan and have progressed, and who have been judged by doctors to be eligible for the TAS-102 combined with bevacizumab biweekly dosing regimen; (4) ECOG physical fitness status score 0-3 points; (5) According to RECIST version 1.1, there are measurable metastatic lesions present; (6) According to the laboratory test values obtained within 7 days before taking the drug on the first day of cycle 1, it has appropriate organ function; (7) Expected lifespan of at least 3 months; (8) Willing and able to comply with research protocols and visit plans.

Exclusion criteria

Exclusion criteria: (1) There are contraindications for TAS-102 and bevacizumab; (2) Other situations deemed unsuitable for inclusion in the study by researchers who have previously received TAS-102 treatment; (3) The investigator judges or other evidence shows that the patient has serious or poorly controlled systemic diseases, including but not limited to: poorly controlled hypertension and diabetes, ischemic heart disease, arrhythmia, interstitial pneumonia, pulmonary fibrosis, renal failure, liver failure, gastrointestinal ulcer or bleeding; (4) Pregnant or lactating women; (5) The researchers determined that the patient had other factors that were not suitable for participating in this study.

Design outcomes

Primary

MeasureTime frame
Objective response rate, ORR;

Secondary

MeasureTime frame
Progression Free Survival, PFS;Overall survival, OS;Disease control rate, DCR;

Countries

China

Contacts

Public ContactLin Xie

Yunnan Cancer Hospital

xielinyanghan@163.com+86 153 6803 0937

Outcome results

None listed

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