Colorectal Cancer MetastaticNCT07031570
Efficacy and Safety of DEB-TACE Combined With HAIC Versus HAIC Alone in Patients With Unresectable CRLM
An observational study of Colorectal Cancer Metastatic, run by Peking University Cancer Hospital & Institute.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Metastatic
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 30 Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with colorectal liver metastases who received DEB-TACE combined with HAIC or HAIC alone at the Department of Interventional Radiology, Peking University Cancer Hospital, between March 2015 and December 2023.
Who may be able to join
- 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
Who cannot join
- 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.
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
Retrospective evaluation of the efficacy and safety of DEB-TACE combined with HAIC versus HAIC alone in patients with unresectable colorectal liver metastases (CRLM)
Read the 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.
- Conditions
- Colorectal Cancer Metastatic
- Keywords
- CRLM, DEB-TACE, HAIC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| observed group | the patient treated with DEB-TACE combined with HAIC | |
| Control group | the patient treated with HAIC only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6-8 weeks after each treatment
Secondary outcomes (4)
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
Measured: Through study completion, an average of 1 year
Treatment efficacy-ORR
ORR=CR+PR
Measured: 6-8 weeks after each treatment
Treatment efficacy-DCR
DCR=CR+PR+SD
Measured: 6-8 weeks after each treatment
treatment safety
the frequency of adverse events after treatment
Measured: within 30 days after each treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhu Xu, Peking University Cancer Hospital & Institute
- Investigators
- XU zhu, MD, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07031570
- Sponsor's protocol ID
- CRLM-DEBTACE-HAIC
- Status last verified
- Jun 2025
- First submitted
- 4 Jun 2025
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07031570
- Acronym / sponsor ID
- CRLM-DEBTACE-HAIC
- Conditions
- Colorectal Cancer Metastatic
- Keywords
- CRLM, DEB-TACE, HAIC
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 22 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| observed group | – | –the patient treated with DEB-TACE combined with HAIC |
| Control group | – | –the patient treated with HAIC only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with colorectal liver metastases who received DEB-TACE combined with HAIC or HAIC alone at the Department of Interventional Radiology, Peking University Cancer Hospital, between March 2015 and December 2023.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Treatment efficacy-PFS
Time frame: 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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
XU zhu, MD principal investigator
Peking University Cancer Hospital & Institute
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer Metastatic, run by Peking University Cancer Hospital & Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aiwei Feng, MD (88196476, ivyfeng_1026@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment efficacy-PFS (time frame: 6-8 weeks after each treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2025.