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New treatment option for Colorectal Cancer
Official title Liposomal Irinotecan and Leucovorin/5-fluorouracil Plus Bevacizumab in Metastatic Colorectal Cancer
ClinicalTrials.gov ID: NCT06184698
What this study is testing
What is liposomal irinotecan?
liposomal irinotecan is an investigational medicine, being studied as a potential treatment for colorectal cancer.
Also referred to as nal-IRI.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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...
- 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.
- 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 people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shijiazhuang, Hebei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shijiazhuang, Hebei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.