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

NCT07031570 | Not Yet Recruiting

• 1 other identifier: CRLM-DEBTACE-HAIC
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Colorectal Cancer Metastatic

Keywords

CRLM; DEB-TACE; HAIC

Outcome Measures

Primary Outcomes (1)

• Treatment efficacy-PFS

  PFS is defined as the time from the date of the first DEB-TACE combined with HAIC or HAIC alone treatment to disease progression or death. PFS will be categorized into intrahepatic PFS and overall PFS.

  6-8 weeks after each treatment

Secondary Outcomes (4)

• Treatment efficacy-OS

  Through study completion, an average of 1 year

• Treatment efficacy-ORR

  6-8 weeks after each treatment

• Treatment efficacy-DCR

  6-8 weeks after each treatment

• treatment safety

  within 30 days after each treatment

Study Arms (2)

observed group

the patient treated with DEB-TACE combined with HAIC

Control group

the patient treated with HAIC only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with colorectal liver metastases who received DEB-TACE combined with HAIC or HAIC alone at the Department of Interventional Radiology, Peking University Cancer Hospital, between March 2015 and December 2023.

You may qualify if:

• Age ≥ 18 years
• No gender restriction
• Pathologically or clinically diagnosed with colorectal liver metastases
• Imaging data available within 31 days prior to enrollment, with at least one measurable lesion (according to RECIST criteria)
• Patients received only DEB-TACE combined with HAIC or HAIC alone during the observation period
• Child-Pugh classification A or B
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

You may not qualify if:

• Presence of treatment risks or contraindications to DEB-TACE combined with HAIC or HAIC alone.
• Concurrent diagnosis of other malignancies.
• Underwent other local treatment modalities during the observation period.
• DEB-TACE combined with HAIC or HAIC alone was used as postoperative adjuvant therapy.
• Missing relevant examination results before or after treatment.
• Incomplete imaging data, making response evaluation impossible.
• Follow-up failure due to incorrect or missing patient information, loss to follow-up, or patient refusal.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Officials

• XU zhu, MD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aiwei Feng, MD

CONTACT

88196476; ivyfeng_1026@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director , Dept of Interventional Therapy

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 22, 2025
• Study Start: July 1, 2025
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: June 22, 2025

Record last verified: 2025-06