Advanced Malignancy, Elderly (People Aged 65 or More), Unresectable Colorectal Cancer
Conditions
Brief summary
We plan to conduct a prospective, two-arm, open-label phase Ⅱ study to evaluate whether transarterial chemoembolization with FOLFOX plus/minus intravenous cetuximab/bevacizumab significantly improves the efficacy and safety compared with systemic FOLFOX therapy plus/minus cetuximab/bevacizumab in elderly patients with advanced unresectable colorectal cancer.
Interventions
PROCEDURETransarterial chemoembolization
Transarterial chemoembolization with FOLFOX plus/minus intravenous cetuximab/bevacizumab
Sponsors
Peking Union Medical College Hospital
Junpeng Wang
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 65 years, gender not restricted Pathologically confirmed advanced colorectal cancer without the opportunity for curative surgery Karnofsky Performance Status (KPS) score ≥ 60, with an estimated survival time ≥ 3 months At least 1 measurable colorectal lesion No prior systemic chemotherapy, or a minimum interval of 6 months between the last chemotherapy and study enrollment Voluntary signing of the informed consent form
Exclusion criteria
* Concomitant other malignant tumors Presence of gastrointestinal perforation Severe cardiovascular and cerebrovascular diseases Patients with hypersensitivity to study drugs or psychiatric disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate；Disease Control Rate | 24 weeks |
Outcome results
None listed