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Clinical Efficacy of Transarterial Chemoembolization in Elderly Patients With Advanced Unresectable Colorectal Cancer

NCT ID: NCT07209384

Last Updated: 2025-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2026-10-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Unresectable Colorectal Cancer Advanced Malignancy Elderly (People Aged 65 or More)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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transarterial chemoembolization with FOLFOX plus/minus intravenous cetuximab/bevacizumab

Group Type EXPERIMENTAL

Transarterial chemoembolization

Intervention Type PROCEDURE

Transarterial chemoembolization with FOLFOX plus/minus intravenous cetuximab/bevacizumab

Interventions

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Transarterial chemoembolization

Transarterial chemoembolization with FOLFOX plus/minus intravenous cetuximab/bevacizumab

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role collaborator

Junpeng Wang

OTHER

Sponsor Role lead

Responsible Party

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Junpeng Wang

Chief physician

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

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2025-10-01

Identifier Type: -

Identifier Source: org_study_id

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