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

Peking University Cancer Hospital & Institute

Status: Not yet enrolling

Conditions: Colorectal Cancer Metastatic

Study type: Observational

Funder types: Other

Identifiers

NCT07031570

CRLM-DEBTACE-HAIC

Details and patient eligibility

About

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

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

500 participants in 2 patient groups

observed group

Description:

the patient treated with DEB-TACE combined with HAIC

Control group

Description:

the patient treated with HAIC only