New treatment for metastatic colorectal cancer using liposomal irinotecan

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multi-center, single-arm study investigates the efficacy and safety of liposomal irinotecan combined with 5-fluorouracil, leucovorin, and bevacizumab as a second-line therapy for metastatic colorectal cancer in a Chinese population. The study aims to improve treatment outcomes by utilizing a novel formulation of irinotecan that enhances drug delivery to cancer cells while minimizing side effects. Participants will be assessed for measurable lesions and must have previously received oxaliplatin-based therapy. The study will evaluate both the effectiveness and safety of this treatment regimen.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.
* 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.

Exclusion Criteria:

* 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.
* 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.

Where it's running

• The Fourth Hospital of Hebei Medical University
  Shijiazhuang, Hebei, China Recruiting

Study contacts

• Principal investigator: Guiying Wang, Professor — Hebei Medical University Fourth Hospital
• Study coordinator: Xuhua Hu, Doctor
• Email: huxvhua@126.com
• Phone: 0311-86095347

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.