Colorectal CancerPhase 2NCT04833036
c-CetuIRI Versus Ersecond-line Irinotecan s-IRI-CetuIRI
A Phase 2 study testing Irinotecan and cetuximab in people with Colorectal Cancer, run by Fudan University at 1 site in China.
Trial summary
The primary endpoint is to evaluate the progression-free survival (PFS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Irinotecan and cetuximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2019to Nov 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signing informed consent;
- Age is greater than or equal to 18 years old;
- Metastatic colorectal adenocarcinoma confirmed by tissue or cytopathology;
- First-line failure to use oxaliplatin combined with fluorouracil (with or without anti-angiogenic targeting drugs);
- One or more measurable lesions, the longest diameter of the spiral CT scan is at least 10 mm, and the diameter of the conventional CT scan is at least 20 mm (the solid tumor efficacy evaluation standard, RECIST standard, version 1.1);
- The Eastern Cancer Cooperative Group (ECOG) has a general status score of 0-2;
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- The bone marrow capacity, liver and kidney function reached the following criteria within 7 days before screening:
- Absolute neutrophil count ≥ 1.5x109 / L; hemoglobin ≥ 9.0 g / dl; platelet count ≥ 80 x 109 / L; total bilirubin ≤ 1.5 times normal upper limit (ULN); alanine aminotransferase and aspartate aminotransferase ≤ 2.5 x ULN Alkaline phosphatase ≤ 3 x ULN; serum creatinine ≤ 1.5 x ULN;
- Women of childbearing age need to take effective contraception.
- RAS, B-RAF gene wild type
Who cannot join
- Previous use of irinotecan or anti-egfr therapy for advanced colorectal cancer (e.g. Cetuximab, panizumab, etc.);
- History of HIV infection or active chronic hepatitis b or c (high copy viral DNA);
- Patients with important organ failure or other important diseases: patients with serious heart disease including congestive heart failure, uncontrolled arrhythmia, angina requiring long-term medication, heart valve disease, myocardial infarction, pericardial effusion with obvious symptoms, and refractory hypertension;A history of severe neurological or psychiatric problems;Severe infection;Active disseminated intravascular coagulation
- Active severe clinical infection;
- Symptomatic brain or meningeal metastasis (unless the patient was treated for > for 6 months, had negative imaging results within 4 weeks prior to study entry, and had stable tumour-related clinical symptoms at study entry);
- Patients whose seizures require treatment (e.g. steroids or antiepileptic therapy);
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- Receiving renal dialysis;
- Have a history of other malignant tumors within 5 years, except for cured cervical carcinoma in situ or skin basal cell carcinoma, except for those whose metastasis can be confirmed by pathology to be from other tumor sources;
- Chronic intestinal diseases, infectious intestinal diseases and intestinal obstruction;
- Drug abuse and medical, psychological or social conditions may interfere with patients' participation in studies or affect the assessment of their findings;
- Any unstable condition or condition that may endanger the safety and compliance of patients;
- Pregnant or lactating women;Having fertility but not taking adequate contraceptive measures;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, 200032
Wei Jian Guo, 13816066360, mingzhuhuang0718@163.com
About this study
Official title: Second-line Irinotecan Combined With Cetuximab (c-CetuIRI) Versus Second-line Irinotecan Three-line Irinotecan Plus Cetuximab (s-IRI-CetuIRI) in the Treatment of Oxaliplatin and 5-FU Phase II Clinical Study of Wild-type Advanced Colorectal Cancer With RAS Gene
The primary endpoint is to evaluate the progression-free survival (PFS).
Read the detailed description
This study was designed for patients with advanced bowel cancer after first-line LOHP and 5-FU treatment failure. The control group was treated with second-line CPT-11+C225. The study group used second-line CPT-11 single drug until the third line was CPT-11+C225. treatment. Referring to the previous literature data, the PFS of the second-line treatment of CPT-11+C225 is about 4 months. This study assumes that the total PFS time of C225 can be extended to 7 months after the failure of second-line CPT-11 treatment compared with the direct second-line combination. , set α = 0.05, β = 0.2, the expected enrollment time is 2 years, the follow-up time is 1 year, the 10% sample shedding rate, the total sample size is about 60 cases per group, a total of 120 cases.
- Conditions
- Colorectal Cancer
- Being tested
- Irinotecan, cetuximab
- Keywords
- 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.
IrinotecanDrug
180 mg/m2, ivgtt d1，q2w
cetuximabDrug
500 mg/m2, ivgtt d1，q2w
| Study group | Role | What they receive |
|---|---|---|
| c-CetuIRI | Active comparator | Irinotecan combined with cetuximab Receives: Drug: Irinotecan; Drug: cetuximab |
| s-IRI-CetuIRI | Experimental | single irinotecan first, then irinotecan plus cetuximab sequentially after PD Receives: Drug: Irinotecan; Drug: cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
progression free survival
Measured: up to 8 weeks
Secondary outcomes (2)
OS
overall survival
Measured: through study completion, an average of half year
ORR
objective response rate
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start1 Oct 2019
- Primary completionJan 2022 (estimated)
- Study completionNov 2022 (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.
- More trials run by Fudan UniversityThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weijian Guo, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04833036
- Sponsor's protocol ID
- Cetu-IRI
- Status last verified
- Apr 2021
- First submitted
- 12 Oct 2019
- Last updated
- 6 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Second-line Irinotecan Combined With Cetuximab (c-CetuIRI) Versus Second-line Irinotecan Three-line Irinotecan Plus Cetuximab (s-IRI-CetuIRI) in the Treatment of Oxaliplatin and 5-FU Phase II Clinical Study of Wild-type Advanced Colorectal Cancer With RAS Gene
- ClinicalTrials.gov ID
- NCT04833036
- Acronym / sponsor ID
- Cetu-IRI
- Conditions
- Colorectal Cancer
- Keywords
- chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 6 Apr 2021 (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.
The primary endpoint is to evaluate the progression-free survival (PFS).
Detailed description
This study was designed for patients with advanced bowel cancer after first-line LOHP and 5-FU treatment failure. The control group was treated with second-line CPT-11+C225. The study group used second-line CPT-11 single drug until the third line was CPT-11+C225. treatment. Referring to the previous literature data, the PFS of the second-line treatment of CPT-11+C225 is about 4 months. This study assumes that the total PFS time of C225 can be extended to 7 months after the failure of second-line CPT-11 treatment compared with the direct second-line combination. , set α = 0.05, β = 0.2, the expected enrollment time is 2 years, the follow-up time is 1 year, the 10% sample shedding rate, the total sample size is about 60 cases per group, a total of 120 cases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| c-CetuIRI | Active comparator | Drug: Irinotecan, Drug: cetuximabIrinotecan combined with cetuximab |
| s-IRI-CetuIRI | Experimental | Drug: Irinotecan, Drug: cetuximabsingle irinotecan first, then irinotecan plus cetuximab sequentially after PD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signing informed consent;
- Age is greater than or equal to 18 years old;
- Metastatic colorectal adenocarcinoma confirmed by tissue or cytopathology;
- First-line failure to use oxaliplatin combined with fluorouracil (with or without anti-angiogenic targeting drugs);
- One or more measurable lesions, the longest diameter of the spiral CT scan is at least 10 mm, and the diameter of the conventional CT scan is at least 20 mm (the solid tumor efficacy evaluation standard, RECIST standard, version 1.1);
Key exclusion criteria (12 listed)
- Previous use of irinotecan or anti-egfr therapy for advanced colorectal cancer (e.g. Cetuximab, panizumab, etc.);
- History of HIV infection or active chronic hepatitis b or c (high copy viral DNA);
- Patients with important organ failure or other important diseases: patients with serious heart disease including congestive heart failure, uncontrolled arrhythmia, angina requiring long-term medication, heart valve disease, myocardial infarction, pericardial effusion with obvious symptoms, and refractory hypertension;A history of severe neurological or psychiatric problems;Severe infection;Active disseminated intravascular coagulation
- Active severe clinical infection;
- Symptomatic brain or meningeal metastasis (unless the patient was treated for > for 6 months, had negative imaging results within 4 weeks prior to study entry, and had stable tumour-related clinical symptoms at study entry);
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 |
|---|---|---|
| Irinotecan180 mg/m2, ivgtt d1，q2w | Drug | c-CetuIRI, s-IRI-CetuIRI |
| cetuximab500 mg/m2, ivgtt d1，q2w | Drug | c-CetuIRI, s-IRI-CetuIRI |
Primary outcome
PFS
Time frame: up to 8 weeks
progression free survival
2 secondary outcomes
OS
Time frame: through study completion, an average of half year
ORR
Time frame: up to 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Irinotecan and cetuximab in people with Colorectal Cancer, run by Fudan University at 1 site in China.
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 10 inclusion and 12 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 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Weijian Guo, Professor (86-21-64175590, mingzhuhuang0718@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 8 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 6 Apr 2021.