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

NCT07585279 | Not Yet Recruiting Phase 2

• 1 other identifier: CSPC-DEY-CRC-K12
• Study Type: interventional
• Target: 408
• Locations: 1 country
• Sites: 1

Brief Summary

Phase II - Treatment Regimen Exploration Stage:

1. 1.Evaluate the safety and efficacy of the following three treatment regimens:
2. 2.Provide a basis for selecting the treatment regimen for the confirmatory phase.
3. 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.

Conditions

Liposomal Irinotecan; Second-Line; Metastatic Colorectal Cancer (CRC)

Outcome Measures

Primary Outcomes (1)

• ORR

  Around 4 years

Secondary Outcomes (4)

• DCR

  Around 4 years

• DoR

  Around 4 years

• PFS

  Around 4 years

• OS

  Around 4 years

Study Arms (3)

Group A

EXPERIMENTAL

Drug: Liposomal irinotecan + 5-FU/LV + bevacizumab + Enlonstobart

Group B

EXPERIMENTAL

Drug: Irinotecan liposome + 5-FU/LV + Bevacizumab

Group C

ACTIVE COMPARATOR

Drug: Irinotecan + 5-FU/LV + Bevacizumab

Interventions

Liposomal irinotecan + 5-FU/LV + bevacizumab + Enlonstobart DRUG

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;

Group A

Irinotecan liposome + 5-FU/LV + Bevacizumab DRUG

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;

Group B

Irinotecan + 5-FU/LV + Bevacizumab DRUG

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;

Group C

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• \) 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Hebei Medical University Fourth Hospital: lead

Study Sites (1)

Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

irinotecan sucrosofate; Bevacizumab; Irinotecan

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Camptothecin; Alkaloids; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hebei Medical University Fourth Hospital

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 13, 2026
• Study Start: May 20, 2026
• Primary Completion (Estimated): February 28, 2031
• Study Completion (Estimated): February 28, 2032
• Last Updated: May 13, 2026

Record last verified: 2026-05

Locations

CN (1)