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Not yet recruiting NCT07031570

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

— Observational Colorectal Cancer Metastatic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Colorectal Cancer Metastatic. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Retrospective Evaluation of the Efficacy and Safety of Drug-Eluting Bead Transarterial Chemoembolization (DEB-TACE) Combined With Hepatic Arterial Infusion Chemotherapy (HAIC) Versus HAIC Alone in Patients With Unresectable Colorectal Cancer Liver Metastases

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)

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.

Primary outcome measures

  • Treatment efficacy-PFS [Time frame: 6-8 weeks after each treatment]
Secondary outcome measures (4)
  • Treatment efficacy-OS [Time frame: Through study completion, an average of 1 year]
  • Treatment efficacy-ORR [Time frame: 6-8 weeks after each treatment]
  • Treatment efficacy-DCR [Time frame: 6-8 weeks after each treatment]
  • treatment safety [Time frame: within 30 days after each treatment]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

\-

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07031570 · CRLM-DEBTACE-HAIC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗