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Recruiting Phase 2

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

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About this 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.

Condition
Colorectal Cancer
Tested
liposomal irinotecan, 5-FU, LV, Bevacizumab
Sponsor
Hebei Medical University Fourth Hospital

Who can join

Age
18 to 75 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 15

  • Minimum age: 18 years
  • Maximum age: 75 years
  • Study condition: Colorectal Cancer
  • 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 20

  • 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

1 site, 1 recruiting

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.