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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 主要终点
- Treatment efficacy-PFS
研究概览
简要总结
Retrospective evaluation of the efficacy and safety of DEB-TACE combined with HAIC versus HAIC alone in patients with unresectable colorectal liver metastases (CRLM)
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Treatment efficacy-PFS
时间窗: 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.
次要结局
- 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)
研究者
Zhu Xu
Director , Dept of Interventional Therapy
Peking University Cancer Hospital & Institute