Colorectal CancerPhase 2NCT06184698
Liposomal Irinotecan and Leucovorin/5-fluorouracil Plus Bevacizumab in Metastatic Colorectal Cancer
A Phase 2 study testing liposomal irinotecan, 5-FU and LV in people with Colorectal Cancer, run by Hebei Medical University Fourth Hospital at 1 site in China.
Trial summary
This is a multi-center, single-arm study to investigate the efficacy and safety of liposomal irinotecan+5-FU/LV+ bevacizumab as second-line therapy in metastatic colorectal cancer in Chinese population. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- liposomal irinotecan, 5-FU and LV
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 1 Mar 2027
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-75 years old.
- Histologically or cytologically proven colon or rectum adenocarcinoma.
- Confirmed as unresectable metastatic disease through radiological examination.
- At least one measurable lesion (according to RECIST v1.1).
- First-line treatment with oxaliplatin-based therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 ~ 2.
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- The expected survival time ≥3 months.
- Subject has adequate biological parameters as demonstrated by the following: absolute neutrophil count (ANC) ≥1.5×10^9/L, platelet count ≥100×10^9/L, hemoglobin (Hgb) ≥90 g/L, white blood cell (WBC)≥3.0×10^9/L.
- Adequate hepatic function as evidenced by total bilirubin ≤1.5 × upper limit of normal (ULN), aspartate aminotransferase (AST), alkaline phosphatase (ALP) and alanine aminotransferase (ALT) ≤2.5 x ULN, ≤5 x ULN if liver metastases are present.
- Adequate renal function as evidenced by serum creatinine (Cr)≤1.5 x ULN or creatinine clearance ≥60 mL/min, proteinuria \<2+.
- Normal coagulation function (INR≤1.5).
- Agree and be able to comply with the plan during the study period. Provide written informed consent before entering the study screening.
Who cannot join
- Any other malignancy within 5 years prior to randomization, with the exception of cured in-situ carcinoma or basal cell carcinoma.
- Previous treatment with irinotecan/liposomal irinotecan.
- MSI-H/dMMR
- Massive pleural effusion or ascites requiring intervention.
- Active, uncontrolled bacterial, viral, or fungal infections that require systemic treatment.
- Active HIV, HBV, HCV infection.
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- Combined with uncontrollable systemic diseases.
- Presence of severe gastrointestinal disease (including active bleeding, \> grade 1 obstruction , \> grade 1 diarrhea or gastrointestinal perforation)
- History of laparotomy, thoracotomy, or intestinal resection within 28 days before enrolment.
- Presence of interstitial pneumonia or pulmonary fibrosis.
- Allergy to or intolerance to therapeutic drugs or their excipients;.
- History of pulmonary hemorrhage/hemoptysis ≥ Grade 2 (defined as bright red blood of at least 2.5mL) within one month prior to enrollment.
- Presence of arterial embolism, severe bleeding (excluding bleeding caused by surgery) or tendency for existing embolism or severe bleeding within 6 months before enrollment.
- Patients with symptomatic central nervous system metastases.
- Documented serum albumin ≤3 g/dL
- Use of strong inhibitors or inducers of CYP3A, CYP2C8 and UGT1A1.
- Pregnant or breastfeeding women, or subjects of childbearing age who refuse contraception.
- Participated in other trial within 30 days prior to the first dose of study treatment.
- Patients who had received any intravenous antineoplastic therapy within 28 days or oral antineoplastic therapy within 14 days before the first dose of study drug
- Patients who are not suitable to participate in this trial for any reason judged by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
Xuhua Hu, 031186095347, wangguiying@hebmu.edu.cn
About this study
Official title: Liposomal Irinotecan + Leucovorin + 5-fluorouracil + Bevacizumab as Second-line Therapy in Metastatic Colorectal Cancer (IRIS)：a Multicenter, Single-arm, Prospective, Phase II Study
This is a multi-center, single-arm study to investigate the efficacy and safety of liposomal irinotecan+5-FU/LV+ bevacizumab as second-line therapy in metastatic colorectal cancer in Chinese population.
Read the detailed description
Colorectal cancer (CRC) has a poor prognosis and poses a serious threat to human health. FOLFIRI (irinotecan+5-FU/LV) / FOLFOX (oxaliplatin+5-FU/LV) ± angiogenesis inhibitors are common treatments for advanced CRC. For patients receiving oxaliplatin-based therapy, irinotecan-based therapy is recommended as second-line therapy. Liposomal irinotecan is a new pharmaceutical form of traditional irinotecan. It adopts a special loading technology to encapsulate traditional irinotecan in liposomes, which can avoid its hydrolysis under physiological conditions, increase the affinity with cancer cells, overcome drug resistance, increase the drug uptake by cancer cells, reduce the drug dose, improve the efficacy and reduce the toxic side effects. The aim of this study is to explore the efficacy and safety of liposomal irinotecan+5-FU/LV + bevacizumab as second-line treatment for metastatic CRC.
- Conditions
- Colorectal Cancer
- Being tested
- liposomal irinotecan, 5-FU, LV, Bevacizumab
- Keywords
- liposomal irinotecan, second-line therapy, metastatic colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liposomal irinotecanDrug
Also called nal-IRI
liposomal irinotecan 70 mg/m²
5-FUDrug
Also called Fluorouracil
5-FU 2400 mg/m²
LVDrug
Also called Calcium folinate
5-FU 2400 mg/m²
BevacizumabDrug
Also called Avastin
bevacizumab 5 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | liposomal irinotecan+5-FU/LV+ bevacizumab q2w Receives: Drug: liposomal irinotecan; Drug: 5-FU; Drug: LV; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Defined as the proportion of patients who achieved complete response (CR) and partial response (PR) according to RECIST v1.1.
Measured: 4 months
Secondary outcomes (5)
Disease Control Rate
Defined as the percentage of patients who achieved CR, PR, and stable disease (SD) according to RECIST v1.1.
Measured: 4 months
Duration of Response
Defined as the time from the initiation of a response (first confirmation of CR or PR) to disease progression or death from any cause, whichever occurred first.
Measured: 4 months
Progress-free survival
Defined as time from the subject's enrollment to first documented disease progression using RECIST version 1.1 by investigator review or death due to any cause, whichever occurred first.
Measured: 6 months
Overall survival
Defined as the time between signing the informed consent form and death due to various causes.
Measured: 1 year
Incidence of adverse events
Use NCI-CTCAE version 5.0 for classification and grading
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start1 Jan 2024
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Mar 2027 (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 Hebei Medical University Fourth HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 173 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Fourth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guiying Wang, Professor, Principal investigator, Hebei Medical University Fourth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184698
- Sponsor's protocol ID
- CSPC-DEY-CRC-K04
- Status last verified
- Sep 2024
- First submitted
- 12 Dec 2023
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liposomal Irinotecan + Leucovorin + 5-fluorouracil + Bevacizumab as Second-line Therapy in Metastatic Colorectal Cancer (IRIS)：a Multicenter, Single-arm, Prospective, Phase II Study
- ClinicalTrials.gov ID
- NCT06184698
- Acronym / sponsor ID
- CSPC-DEY-CRC-K04
- Conditions
- Colorectal Cancer
- Keywords
- liposomal irinotecan, second-line therapy, metastatic colorectal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 173 participants (estimated)
- Lead sponsor
- Hebei Medical University Fourth HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 28 Dec 2023 (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 multi-center, single-arm study to investigate the efficacy and safety of liposomal irinotecan+5-FU/LV+ bevacizumab as second-line therapy in metastatic colorectal cancer in Chinese population.
Detailed description
Colorectal cancer (CRC) has a poor prognosis and poses a serious threat to human health. FOLFIRI (irinotecan+5-FU/LV) / FOLFOX (oxaliplatin+5-FU/LV) ± angiogenesis inhibitors are common treatments for advanced CRC. For patients receiving oxaliplatin-based therapy, irinotecan-based therapy is recommended as second-line therapy. Liposomal irinotecan is a new pharmaceutical form of traditional irinotecan. It adopts a special loading technology to encapsulate traditional irinotecan in liposomes, which can avoid its hydrolysis under physiological conditions, increase the affinity with cancer cells, overcome drug resistance, increase the drug uptake by cancer cells, reduce the drug dose, improve the efficacy and reduce the toxic side effects. The aim of this study is to explore the efficacy and safety of liposomal irinotecan+5-FU/LV + bevacizumab as second-line treatment for metastatic CRC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: liposomal irinotecan, Drug: 5-FU, Drug: LV, Drug: Bevacizumabliposomal irinotecan+5-FU/LV+ bevacizumab q2w |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age: 18-75 years old.
- Histologically or cytologically proven colon or rectum adenocarcinoma.
- Confirmed as unresectable metastatic disease through radiological examination.
- At least one measurable lesion (according to RECIST v1.1).
- First-line treatment with oxaliplatin-based therapy.
Key exclusion criteria (20 listed)
- Any other malignancy within 5 years prior to randomization, with the exception of cured in-situ carcinoma or basal cell carcinoma.
- Previous treatment with irinotecan/liposomal irinotecan.
- MSI-H/dMMR
- Massive pleural effusion or ascites requiring intervention.
- Active, uncontrolled bacterial, viral, or fungal infections that require systemic treatment.
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 |
|---|---|---|
| liposomal irinotecanAlso: nal-IRIliposomal irinotecan 70 mg/m² | Drug | Experimental Group |
| 5-FUAlso: Fluorouracil5-FU 2400 mg/m² | Drug | Experimental Group |
| LVAlso: Calcium folinate5-FU 2400 mg/m² | Drug | Experimental Group |
| BevacizumabAlso: Avastinbevacizumab 5 mg/kg | Drug | Experimental Group |
Primary outcome
Objective Response Rate
Time frame: 4 months
Defined as the proportion of patients who achieved complete response (CR) and partial response (PR) according to RECIST v1.1.
5 secondary outcomes
Disease Control Rate
Time frame: 4 months
Duration of Response
Time frame: 4 months
Progress-free survival
Time frame: 6 months
Overall survival
Time frame: 1 year
Incidence of adverse events
Time frame: 5 months
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 9 Oct 2024.
- 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.
Guiying Wang, Professor principal investigator
Hebei Medical University Fourth Hospital
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 liposomal irinotecan, 5-FU and LV in people with Colorectal Cancer, run by Hebei Medical University Fourth Hospital 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 12 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 9 Oct 2024. 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?
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 Xuhua Hu, Doctor (0311-86095347, huxvhua@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: 4 months). 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 9 Oct 2024.