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

N/ANot Yet RecruitingNCT07031570

Peking University Cancer Hospital & Institute500 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Colorectal Cancer Metastatic

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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. \-

Outcomes

Primary Outcomes

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.

Time frame: 6-8 weeks after each treatment

Secondary Outcomes

Treatment efficacy-OS

OS is defined as the time from the date of the first DEB-TACE combined with HAIC or HAIC alone treatment to death

Time frame: Through study completion, an average of 1 year

Treatment efficacy-ORR

ORR=CR+PR

Time frame: 6-8 weeks after each treatment

Treatment efficacy-DCR

DCR=CR+PR+SD

Time frame: 6-8 weeks after each treatment

treatment safety

the frequency of adverse events after treatment

Time frame: within 30 days after each treatment

Central Contacts

Aiwei Feng, MD

CONTACT

88196476 ivyfeng_1026@163.com

Data from ClinicalTrials.gov

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