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Metastatic Colorectal Cancer (CRC)Phase 2/3NCT07585279

A Clinical Study of Liposomal Irinotecan for Second-Line Therapy in Metastatic Colorectal Cancer

A Phase 2/3 study testing Liposomal irinotecan + 5-FU/LV + bevacizumab + Enlonstobart, Irinotecan liposome + 5-FU/LV + Bevacizumab and Irinotecan + 5-FU/LV + Bevacizumab in people with Metastatic Colorectal Cancer (CRC) and Liposomal Irinotecan, run by Hebei Medical University Fourth Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Phase II - Treatment Regimen Exploration Stage: 1. Evaluate the safety and efficacy of the following three treatment regimens: Liposomal irinotecan + 5-FU/LV + bevacizumab + Enlonstobart (Group A) Liposomal irinotecan + 5-FU/LV + bevacizumab (Group B) Irinotecan + 5-FU/LV + bevacizumab (Group C) 2. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Liposomal irinotecan + 5-FU/LV + bevacizumab + Enlonstobart, Irinotecan liposome + 5-FU/LV + Bevacizumab and Irinotecan + 5-FU/LV + Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
408 participants
Where
1 siteChina
Study dates
20 May 2026to 28 Feb 2032
Phase
Phase 2/3
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

  • Aged ≥ 18 years old and ≤ 75 years old.
  • Histologically or cytologically confirmed metastatic colon or rectal adenocarcinoma;
  • Patients must have at least one measurable lesion according to RECIST 1.1 criteria.
  • Had received first-line treatment based on oxaliplatin.
  • Eastern Cooperative Oncology Group performance status score of 0, 1, or 2;
  • Expected survival time ≥3 months.
  • Adequate organ function, meeting the following laboratory test standards:
  • 1) Bone marrow function: Neutrophils≥1.5×109/L, Platelets≥100×109/L, Hemoglobin≥90 g/L, White blood cells ≥3.0×109/L; 2) Liver function:Alanine aminotransferase, Aspartate aminotransferase, Alkaline phosphatase≤2.5×upper limit of normal (ULN), when there is liver metastasis, ≤ 5×ULN; Total bilirubin≤1.5×ULN; 3) Renal function: Serum creatinine ≤1.5×ULN or creatinine clearance rate ≥ 60 ml/min, Urine protein≤2+; 4) Coagulation function: Activated partial thromboplastin time and International Normalized Ratio ≤1.5 × ULN; 5) Thyroid function: Thyroid stimulating hormone≤ULN; If abnormal, additional tests for FT3 and FT4 should be conducted and their levels should be normal; 6) Albumin≥3 g/dL; 8. Pregnant women of childbearing age with negative pregnancy test and non-lactating, participants with reproductive capacity must receive effective contraceptive measures; 9. Patients and/or legal representative must have the ability to understand and voluntarily sign a written informed consent.

Who cannot join

  • Patients with a history of other malignancies within the past 5 years, except for cured carcinoma in situ or basal cell carcinoma of the skin.
  • Prior treatment with irinotecan or liposomal irinotecan-based chemotherapy, or prior treatment with immune checkpoint inhibitors (including but not limited to PD-1 inhibitors, PD-L1 inhibitors, and CTLA-4 inhibitors).
  • Patients with left-sided colorectal cancer, RAS/BRAF wild-type, who did not receive cetuximab in first-line therapy.
  • Patients with known mismatch repair dysfunction or microsatellite instability ;
  • Patients with a large amount of pleural effusion or ascites that require drug intervention treatment;
  • Patients with active, uncontrolled bacterial, viral, or fungal infections requiring systemic treatment, who show persistent signs/symptoms without improvement despite appropriate antimicrobial therapy.
Show all 21Show fewer
  • Known active HIV infection; untreated active HBV or HCV infection.
  • Patients with uncontrolled systemic diseases, including: cardiac disease of NYHA Class II or above; uncontrolled hypertension (defined as systolic blood pressure≥140 mmHg and/or diastolic blood pressure≥90 mmHg despite standard antihypertensive therapy) or a history of hypertensive crisis or hypertensive encephalopathy; uncontrolled diabetes mellitus; etc.
  • Patients with active autoimmune diseases, or with a history of autoimmune disease within 2 years prior to enrollment that still requires systemic therapy. Exceptions include participants with well-controlled type 1 diabetes, hypothyroidism controlled with hormone replacement alone, skin disorders not requiring systemic treatment, or those in whom recurrence is not anticipated in the absence of external triggers.
  • Patients with primary immunodeficiency diseases or with a history;
  • Patients who have received immunosuppressant treatment within 14 days before enrollment or require daily systemic steroid treatment (such as > 20 mg/day prednisone or equivalent drugs), except those treated with nasal, inhalation or other routes of local glucocorticoid therapy;
  • Patients with severe gastrointestinal diseases;
  • History of abdominal surgery, thoracic surgery, or intestinal resection within 28 days prior to enrollment.
  • Had interstitial lung disease or non-infectious pneumonia requiring glucocorticoid treatment;
  • Known hypersensitivity or intolerance to the investigational drugs or their excipients.
  • History of pulmonary hemorrhage or hemoptysis of grade 2 or higher (defined as at least 2.5 mL of bright red blood) within 1 month prior to enrollment.
  • History of arterial thromboembolism, severe bleeding (excluding surgical bleeding), or active thromboembolic or severe bleeding events within 6 months prior to enrollment.
  • Had symptomatic central nervous system metastasis;
  • Had strong inhibitors or inducers of CYP3A4, CYP2C8 and UGT1A1;
  • Receipt of intravenous antitumor therapy within 28 days, or oral antitumor medication within 14 days, prior to the first dose of study drug.
  • Patients judged by the investigator to be unsuitable to participate in this study.

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

  • Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei

    Gui ying Wang, 86+13932186739, wangguiying@hebmu.edu.cn

Other trials in China

About this study

Official title: Liposomal Irinotecan-based Regimen Versus Irinotecan-based Regimen in Second-Line Treatment for Metastatic Colorectal Cancer (IRIS-02): A Randomized, Controlled Phase II/Ⅲ Study

Phase II - Treatment Regimen Exploration Stage:

  1. Evaluate the safety and efficacy of the following three treatment regimens: Liposomal irinotecan + 5-FU/LV + bevacizumab + Enlonstobart (Group A) Liposomal irinotecan + 5-FU/LV + bevacizumab (Group B) Irinotecan + 5-FU/LV + bevacizumab (Group C)
  2. Provide a basis for selecting the treatment regimen for the confirmatory phase.
  3. Explore the relationship between tumor tissue, stool, and blood biomarkers and efficacy and adverse reactions in liposomal irinotecan combination regimens versus irinotecan combination regimens.
Read more

Phase III - Efficacy Confirmation Stage:

Compare the efficacy and safety of liposomal irinotecan combination regimens versus irinotecan combination regimens in second-line treatment of metastatic colorectal cancer.

Being tested
Liposomal irinotecan + 5-FU/LV + bevacizumab + Enlonstobart, Irinotecan liposome + 5-FU/LV + Bevacizumab, Irinotecan + 5-FU/LV + Bevacizumab
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 irinotecan + 5-FU/LV + bevacizumab + EnlonstobartDrug

    Irinotecan liposome: 70mg/m², intravenous infusion within 90 minutes; 5-FU: 400mg/m², intravenous injection followed by 2400mg/m² continuous intravenous infusion within 46 hours; LV: 400mg/m², intravenous infusion within 30 minutes; Bevacizumab: 5mg/kg, intravenous infusion within 30-90 minutes; Enlonstobart: 240mg, intravenous infusion for no less than 60 minutes;

  • Irinotecan liposome + 5-FU/LV + BevacizumabDrug

    Irinotecan liposome: 70mg/m², intravenous infusion within 90 minutes; 5-FU: 400mg/m², intravenous injection followed by 2400mg/m² continuous intravenous infusion within 46 hours; LV: 400mg/m², intravenous infusion within 30 minutes; Bevacizumab: 5mg/kg, intravenous infusion within 30-90 minutes;

  • Irinotecan + 5-FU/LV + BevacizumabDrug

    Irinotecan: 180mg/m², intravenous infusion within 90 minutes; 5-FU: 400mg/m², intravenous injection followed by 2400mg/m² continuous intravenous infusion within 46 hours; LV: 400mg/m², intravenous infusion within 30 minutes; Bevacizumab: 5mg/kg, intravenous infusion within 30-90 minutes;

Study groups in NCT07585279
Study groupRoleWhat they receive
Group AExperimentalNot described
Receives: Drug: Liposomal irinotecan + 5-FU/LV + bevacizumab + Enlonstobart
Group BExperimentalNot described
Receives: Drug: Irinotecan liposome + 5-FU/LV + Bevacizumab
Group CActive comparatorNot described
Receives: Drug: Irinotecan + 5-FU/LV + Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR

    Measured: Around 4 years

Secondary outcomes (4)

  1. DCR

    Measured: Around 4 years

  2. DoR

    Measured: Around 4 years

  3. PFS

    Measured: Around 4 years

  4. OS

    Measured: Around 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2026
  2. Study start20 May 2026 (estimated)
  3. Primary completion28 Feb 2031 (estimated)
  4. Study completion28 Feb 2032 (estimated)

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
408 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07585279
Sponsor's protocol ID
CSPC-DEY-CRC-K12
Status last verified
May 2026
First submitted
7 May 2026
Last updated
13 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Liposomal irinotecan + 5-FU/LV + bevacizumab + Enlonstobart, Irinotecan liposome + 5-FU/LV + Bevacizumab and Irinotecan + 5-FU/LV + Bevacizumab in people with Metastatic Colorectal Cancer (CRC) and Liposomal Irinotecan, 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 8 inclusion and 21 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 13 May 2026. 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: Around 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07585279.

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 13 May 2026.

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