Unresectable Colorectal CancerPhase 2NCT07209384
Clinical Efficacy of Transarterial Chemoembolization in Elderly Patients With Advanced Unresectable Colorectal Cancer
A Phase 2 study testing Transarterial chemoembolization in people with Unresectable Colorectal Cancer and Advanced Malignancy, run by Junpeng Wang.
Trial summary
We plan to conduct a prospective, two-arm, open-label phase Ⅱ study to evaluate whether transarterial chemoembolization with FOLFOX plus/minus intravenous cetuximab/bevacizumab significantly improves the efficacy and safety compared with systemic FOLFOX therapy plus/minus cetuximab/bevacizumab in elderly patients with… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Unresectable Colorectal Cancer, Advanced Malignancy, Elderly (People Aged 65 or More)
- What is being tested?
- Transarterial chemoembolization
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Oct 2026
- Phase
- Phase 2
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 65 years, gender not restricted Pathologically confirmed advanced colorectal cancer without the opportunity for curative surgery Karnofsky Performance Status (KPS) score ≥ 60, with an estimated survival time ≥ 3 months At least 1 measurable colorectal lesion No prior systemic chemotherapy, or a minimum interval of 6 months between the last chemotherapy and study enrollment Voluntary signing of the informed consent form
Who cannot join
- Concomitant other malignant tumors Presence of gastrointestinal perforation Severe cardiovascular and cerebrovascular diseases Patients with hypersensitivity to study drugs or psychiatric disorders
About this study
Official title: CLINICAL EFFICACY OF TRANSARTERIAL CHEMOEMBOLIZATION IN ELDERLY PATIENTS WITH ADVANCED UNRESECTABLE COLORECTAL CANCER
We plan to conduct a prospective, two-arm, open-label phase Ⅱ study to evaluate whether transarterial chemoembolization with FOLFOX plus/minus intravenous cetuximab/bevacizumab significantly improves the efficacy and safety compared with systemic FOLFOX therapy plus/minus cetuximab/bevacizumab in elderly patients with advanced unresectable colorectal cancer.
- Being tested
- Transarterial chemoembolization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transarterial chemoembolizationProcedure or surgery
Transarterial chemoembolization with FOLFOX plus/minus intravenous cetuximab/bevacizumab
| Study group | Role | What they receive |
|---|---|---|
| transarterial chemoembolization with FOLFOX plus/minus intravenous cetuximab/bevacizumab | Experimental | Not described Receives: Procedure: Transarterial chemoembolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate；Disease Control Rate
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Colorectal CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Junpeng Wang
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College Hospital
- Responsible party
- Sponsor-investigator, Junpeng Wang, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07209384
- Sponsor's protocol ID
- 2025-10-01
- Status last verified
- Oct 2025
- First submitted
- 1 Oct 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLINICAL EFFICACY OF TRANSARTERIAL CHEMOEMBOLIZATION IN ELDERLY PATIENTS WITH ADVANCED UNRESECTABLE COLORECTAL CANCER
- ClinicalTrials.gov ID
- NCT07209384
- Acronym / sponsor ID
- 2025-10-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Junpeng WangUniversity, hospital or other
- Collaborators
- Peking Union Medical College Hospital
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 7 Oct 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.
We plan to conduct a prospective, two-arm, open-label phase Ⅱ study to evaluate whether transarterial chemoembolization with FOLFOX plus/minus intravenous cetuximab/bevacizumab significantly improves the efficacy and safety compared with systemic FOLFOX therapy plus/minus cetuximab/bevacizumab in elderly patients with advanced unresectable colorectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| transarterial chemoembolization with FOLFOX plus/minus intravenous cetuximab/bevacizumab | Experimental | Procedure: Transarterial chemoembolization |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Age ≥ 65 years, gender not restricted Pathologically confirmed advanced colorectal cancer without the opportunity for curative surgery Karnofsky Performance Status (KPS) score ≥ 60, with an estimated survival time ≥ 3 months At least 1 measurable colorectal lesion No prior systemic chemotherapy, or a minimum interval of 6 months between the last chemotherapy and study enrollment Voluntary signing of the informed consent form
Key exclusion criteria (1 listed)
- Concomitant other malignant tumors Presence of gastrointestinal perforation Severe cardiovascular and cerebrovascular diseases Patients with hypersensitivity to study drugs or psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transarterial chemoembolizationTransarterial chemoembolization with FOLFOX plus/minus intravenous cetuximab/bevacizumab | Procedure or surgery | transarterial chemoembolization with FOLFOX plus/minus intravenous cetuximab/bevacizumab |
Primary outcome
Objective Response Rate；Disease Control Rate
Time frame: 24 weeks
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 7 Oct 2025.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Transarterial chemoembolization in people with Unresectable Colorectal Cancer and Advanced Malignancy, run by Junpeng Wang.
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 1 inclusion and 1 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 7 Oct 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate；Disease Control Rate (time frame: 24 weeks). 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 7 Oct 2025.