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

NCT07209384 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 2025-10-01
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate；Disease Control Rate

  24 weeks

Study Arms (1)

transarterial chemoembolization with FOLFOX plus/minus intravenous cetuximab/bevacizumab

EXPERIMENTAL

Procedure: Transarterial chemoembolization

Interventions

Transarterial chemoembolization PROCEDURE

Transarterial chemoembolization with FOLFOX plus/minus intravenous cetuximab/bevacizumab

transarterial chemoembolization with FOLFOX plus/minus intravenous cetuximab/bevacizumab

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Concomitant other malignant tumors Presence of gastrointestinal perforation Severe cardiovascular and cerebrovascular diseases Patients with hypersensitivity to study drugs or psychiatric disorders

Sponsors & Collaborators

• Junpeng Wang: lead
• Peking Union Medical College Hospital: collaborator

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: October 7, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share