Colorectal CancerPhase 2NCT05340231
An Exploratory Study of Sequential Transarterial Chemoembolization With Lipiodol and Neoadjuvant Chemotherapy in the Treatment of Initial Unresectable Colorectal Cancer (CRC)
A Phase 2 study testing TACE protocol and Neoadjuvant Chemotherapy in people with Colorectal Cancer, run by Gang Wu.
Trial summary
This is a prospective, open-labelled study to evaluate the efficacy and safety of sequetial transarterial chemoembolization with lipiodol and neoadjuvant chemotherapy in the treatment of initial unresectable colorectal cancer. The progression-free-survival (PFS) will be evaluated as the primary endpoints. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- TACE protocol and Neoadjuvant Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2022to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has fully understood and voluntarily signed an written Informed Consent and agreed to follow the research plan treatment and visiting plan;
- Aged >=18 years, <= 85 years;
- Histologically confirmed initial unresectable colorectal cancer;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- Expected survival period ≥ 3 months;
- At least one measurable lesion, according to RECIST 1.1;
- The main function is normal.
Who cannot join
- Known hypersensitivity to any of the study drugs or excipients;
- Hypertension that is not controlled by the drug;
- International normalized ratio (INR) > 1.5 or partially activated prothrombin time (APTT) > 1.5 × ULN;
- WBC count < 3000 /mm^3;
- Platlet count < 50000 /mm^3;
- Poorly controlled diabetes before enrollment;
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- Clinically significant electrolyte abnormalities judged by researchers;
- Patients with obvious evidence of bleeding tendency or medical history of hematochezia within 3 months before enrollment;
- Cardiovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe / unstable angina pectoris or coronary artery bypass grafting within 6 months before enrollment; Congestive heart failure, New York Heart Association (NYHA) grade > 2; ventricular arrhythmia requiring drug treatment; LVEF (left ventricular ejection fraction) < 50%;
- Active infection or serious infection that is not controlled by drug;
- History of clinically significant hepatic disease (ALT and/or AST >5 times the upper normal limit);
- Women who are pregnant or lactating;
- Urinary protein ≥ ++, and the 24-hour urine protein quantification is greater than 1.0g;
- Have any other disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other conditions, which according to the judgment of the investigator, it is reasonable to suspect that the patient is not suitable for the use of the study drug.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: An Exploratory Study of Sequential Transarterial Chemoembolization With Lipiodol and Neoadjuvant Chemotherapy in the Treatment of Initial Unresectable Colorectal Cancer
This is a prospective, open-labelled study to evaluate the efficacy and safety of sequetial transarterial chemoembolization with lipiodol and neoadjuvant chemotherapy in the treatment of initial unresectable colorectal cancer. The progression-free-survival (PFS) will be evaluated as the primary endpoints.
- Conditions
- Colorectal Cancer
- Being tested
- TACE protocol, Neoadjuvant Chemotherapy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACE protocolDrug
Transarterial infusion chemotherapy: Oxaliplatin(85mg/m^2)+Raltitrexed(3mg) Chemoembolization: Lipiodol emulsion (lipiodol 10ml+ Oxaliplatin 85mg +Lidocaine 1ml)，The endpoint for embolization was defined as stagnation of blood flow of the posterior mesenteric artery.
Intervention cycle：4W; Treatment times: 2. followed by mFOLFOX6
Neoadjuvant ChemotherapyDrug
mFOLFOX6, Q2W
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | sequential transarterial chemoembolization with lipiodol and neoadjuvant chemotherapy Receives: Drug: TACE protocol |
| Control group | Active comparator | neoadjuvant chemotherapy alone Receives: Drug: Neoadjuvant Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
PFS was defined as the time from recruitment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.
Measured: up to 3 years
Secondary outcomes (3)
ORR
ORR is defined as the percentages of patients, relative to the total of enrolled subjects, achieving a complete (CR) or partial (PR) response, according to RECIST 1.1 criteria
Measured: up to 3 years
Overall survival (OS)
The time from recruitment to death due to any cause.
Measured: up to 3 years
Pathological response rate (PCR+MPR)
Pathologic complete response (pCR) was defined as absence of viable tumor in the post-treatment surgical specimens and major pathologic response (MPR) was defined as ≤ 10% viable tumor.
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start1 May 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gang Wu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gang Wu, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05340231
- Sponsor's protocol ID
- CRC-2022-01
- Status last verified
- Apr 2022
- First submitted
- 15 Apr 2022
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of Sequential Transarterial Chemoembolization With Lipiodol and Neoadjuvant Chemotherapy in the Treatment of Initial Unresectable Colorectal Cancer
- ClinicalTrials.gov ID
- NCT05340231
- Acronym / sponsor ID
- CRC-2022-01
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Gang WuUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Apr 2022 (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.
This is a prospective, open-labelled study to evaluate the efficacy and safety of sequetial transarterial chemoembolization with lipiodol and neoadjuvant chemotherapy in the treatment of initial unresectable colorectal cancer. The progression-free-survival (PFS) will be evaluated as the primary endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Drug: TACE protocolsequential transarterial chemoembolization with lipiodol and neoadjuvant chemotherapy |
| Control group | Active comparator | Drug: Neoadjuvant Chemotherapyneoadjuvant chemotherapy alone |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Has fully understood and voluntarily signed an written Informed Consent and agreed to follow the research plan treatment and visiting plan;
- Aged >=18 years, <= 85 years;
- Histologically confirmed initial unresectable colorectal cancer;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- Expected survival period ≥ 3 months;
Key exclusion criteria (14 listed)
- Known hypersensitivity to any of the study drugs or excipients;
- Hypertension that is not controlled by the drug;
- International normalized ratio (INR) > 1.5 or partially activated prothrombin time (APTT) > 1.5 × ULN;
- WBC count < 3000 /mm^3;
- Platlet count < 50000 /mm^3;
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 |
|---|---|---|
| TACE protocolTransarterial infusion chemotherapy: Oxaliplatin(85mg/m^2)+Raltitrexed(3mg) Chemoembolization: Lipiodol emulsion (lipiodol 10ml+ Oxaliplatin 85mg +Lidocaine 1ml)，The endpoint for embolization was defined as stagnation of blood flow of the posterior mesenteric artery. Intervention cycle：4W; Treatment times: 2. followed by mFOLFOX6 | Drug | Study group |
| Neoadjuvant ChemotherapymFOLFOX6, Q2W | Drug | Control group |
Primary outcome
PFS
Time frame: up to 3 years
PFS was defined as the time from recruitment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.
3 secondary outcomes
ORR
Time frame: up to 3 years
Overall survival (OS)
Time frame: up to 3 years
Pathological response rate (PCR+MPR)
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TACE protocol and Neoadjuvant Chemotherapy in people with Colorectal Cancer, run by Gang Wu.
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 14 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: status not confirmed, as of the sponsor's last update on 22 Apr 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gang Wu, M.D. (+86 13938570175, wuganghenan2015@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: up to 3 years). 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 Apr 2022.