Efficacy and Safety of DEB-TACE Combined With HAIC Versus HAIC Alone in Patients With Unresectable CRLM

NCT ID: NCT07031570

Last Updated: 2025-06-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2025-09-30

Brief Summary

Retrospective evaluation of the efficacy and safety of DEB-TACE combined with HAIC versus HAIC alone in patients with unresectable colorectal liver metastases (CRLM)

Detailed Description

This study is a retrospective, non-randomized, single-arm, single-center clinical study. Patients who received DEB-TACE combined with HAIC or HAIC alone were screened from the treatment records of the Department of Interventional Radiology at Peking University Cancer Hospital between March 2015 and December 2023. The study aims to observe treatment efficacy, disease progression, and postoperative adverse reactions to evaluate the effectiveness and safety of combination therapy versus HAIC alone in patients with colorectal liver metastases (CRLM). Analyses will be conducted based on various parameters, including but not limited to HAIC perfusion regimens and drug-eluting bead tumor characteristics.

The primary endpoint of the study is progression-free survival (PFS). Secondary endpoints include overall survival (OS), objective response rate (ORR), disease control rate (DCR), and safety. PFS is defined as the time from the first DEB-TACE plus HAIC or HAIC-alone treatment to disease progression. PFS will be categorized into intrahepatic PFS and overall PFS.

Conditions

Colorectal Cancer Metastatic

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

observed group

the patient treated with DEB-TACE combined with HAIC

No interventions assigned to this group

Control group

the patient treated with HAIC only

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years

2. No gender restriction

3. Pathologically or clinically diagnosed with colorectal liver metastases

4. Imaging data available within 31 days prior to enrollment, with at least one measurable lesion (according to RECIST criteria)

5. Patients received only DEB-TACE combined with HAIC or HAIC alone during the observation period

6. Child-Pugh classification A or B

7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Exclusion Criteria

1. Presence of treatment risks or contraindications to DEB-TACE combined with HAIC or HAIC alone.

2. Concurrent diagnosis of other malignancies.

3. Underwent other local treatment modalities during the observation period.

4. DEB-TACE combined with HAIC or HAIC alone was used as postoperative adjuvant therapy.

5. Missing relevant examination results before or after treatment.

6. Incomplete imaging data, making response evaluation impossible.

7. Follow-up failure due to incorrect or missing patient information, loss to follow-up, or patient refusal.

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• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: lead

Responsible Party

Zhu Xu

Director , Dept of Interventional Therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

XU zhu, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Central Contacts

Aiwei Feng, MD

Role: CONTACT

ivyfeng_1026@163.com

88196476

Other Identifiers

CRLM-DEBTACE-HAIC

Identifier Type: -

Identifier Source: org_study_id