Colorectal Cancer Metastatic
Conditions
Keywords
CRLM, DEB-TACE, HAIC
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.
Interventions
None listed
Sponsors
Peking University Cancer Hospital & Institute
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment efficacy-PFS | 6-8 weeks after each treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment efficacy-OS | Through study completion, an average of 1 year | OS is defined as the time from the date of the first DEB-TACE combined with HAIC or HAIC alone treatment to death |
| Treatment efficacy-ORR | 6-8 weeks after each treatment | ORR=CR+PR |
| Treatment efficacy-DCR | 6-8 weeks after each treatment | DCR=CR+PR+SD |
| treatment safety | within 30 days after each treatment | the frequency of adverse events after treatment |
Contacts
Primary ContactAiwei Feng, MD
Outcome results
None listed