RecruitingPhase 2NCT06184698

Liposomal Irinotecan and Leucovorin/5-fluorouracil Plus Bevacizumab in Metastatic Colorectal Cancer

Liposomal Irinotecan + Leucovorin + 5-fluorouracil + Bevacizumab as Second-line Therapy in Metastatic Colorectal Cancer (IRIS)：a Multicenter, Single-arm, Prospective, Phase II Study

Sponsor

Hebei Medical University Fourth Hospital

Enrollment

173 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

Colorectal, Cancer

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria12

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 Criteria20

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.