Status:
RECRUITING
Liposomal Irinotecan and Leucovorin/5-fluorouracil Plus Bevacizumab in Metastatic Colorectal Cancer
Lead Sponsor:
Hebei Medical University Fourth Hospital
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 populatio...
Detailed Description
Colorectal cancer (CRC) has a poor prognosis and poses a serious threat to human health. FOLFIRI (irinotecan+5-FU/LV) / FOLFOX (oxaliplatin+5-FU/LV) ± angiogenesis inhibitors are common treatments for...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
173 Patients enrolled
Trial Details
Trial ID
NCT06184698
Start Date
January 1 2024
End Date
March 1 2027
Last Update
October 9 2024
Active Locations (1)
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1
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050000