Phase II Study of Irinotecan Liposomes in First-line Treatment of Metastatic Colorectal Cancer

Trial Title: Phase II Study of Irinotecan Liposomes in First-line Treatment of Metastatic Colorectal Cancer

NCT ID: NCT06341296

Condition: Metastatic Colorectal Cancer

Conditions: Official terms:
Colorectal Neoplasms
Bevacizumab
Irinotecan

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Irinotecan Liposome
Description: 70 mg/m^2 , d1, 14 days per cycle, 8 cycles.
Arm group label: irinotecan liposome injection combined with 5-FU/LV+ bevacizumab

Intervention type: Drug
Intervention name: 5-FU
Description: 5-FU 400mg/m^2, then 2400mg/m^2, continuous intravenous infusion for 46-48h, d1-2, 14 days per cycle, 8 cycles.
Arm group label: irinotecan liposome injection combined with 5-FU/LV+ bevacizumab

Intervention type: Drug
Intervention name: LV
Description: 400mg/m^2, d1, 14 days per cycle, 8 cycles.
Arm group label: irinotecan liposome injection combined with 5-FU/LV+ bevacizumab

Intervention type: Drug
Intervention name: Bevacizumab
Description: 5mg/kg, d1, 14 days per cycle, 8 cycles.
Arm group label: irinotecan liposome injection combined with 5-FU/LV+ bevacizumab

Summary: To evaluate the objective response rate, disease control rate, progression-free survival, overall survival, surgical conversion rate and safety of irinotecan liposome combined with 5-FU/LV+ bevacizumab regimen in first-line treatment of advanced metastatic colorectal cancer patients.

Detailed description: This is a Phase II clinical study to evaluate the efficacy and safety of the combination regimen of irinotecan liposome injection in the first-line treatment of metastatic colorectal cancer. Patients will receive liposomal injections of irinotecan 70mg/m^2 d1, bevacizumab 5mg/kg d1, LV 400mg/m^2 d1, 5-FU 400mg/m^2, then 2400mg/m^2, continuous intravenous infusion for 46-48h, d1-2. 86 eligible patients will be enrolled.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - 18~85 years old. - Histopathologically confirmed patient with an inoperable metastatic colorectal adenocarcinoma. - RAS/BRAF v600e mutant or right half colon cancer is known. - pMMR/MSS is known. - The unresectable stage of metastatic disease has not received any systemic antitumor therapy. - For subjects previously receiving neoadjuvant or adjuvant therapy, the date of first discovery of disease progression must be at least 6 months removed from the date of last administration of neoadjuvant or adjuvant therapy. - ECOG 0~1, patients ≥75 years old need an ECOG score of 0 - The presence of at least 1 measurable lesion that can be evaluated according to the RECIST v1.1 criteria. - Normal bone marrow and organ function: ① Neutrophils (ANC) ≥1.5×10^9/L, platelets (PLT) ≥100×10^9/L, hemoglobin (Hb) ≥80g/L, albumin (ALB) ≥30 g/L, white blood cells (WBC) ≥3.0×10^9/L, and no bleeding tendency; ② AST, ALT and alkaline phosphatase (ALP) were all ≤2.5× upper limit of normal range (ULN), and ≤5×ULN when liver metastases occurred; The total bilirubin level doesn't exceed the upper limit of the agency's normal range; Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance ≥40 ml/min (calculated according to Cockroft-Gault) - Understand the situation of this study, patients and/or legal representatives voluntarily agree to participate in this study and sign informed consent form. Exclusion Criteria: - Known or suspected central nervous system metastasis. - Received irinotecan/irinotecan liposomes/bevacizumab before enrollment. - Had undergone surgery and other oncologic treatments within the first 4 weeks of enrollment. - Previous treatment-related toxicity didn't return to NCI-CTCAE v5.0 I or below(except hair loss and peripheral neuropathy). - The use of CYP3A, CYP2C8, and UGT1A1 inhibitors or inducers couldn't be discontinued or were not discontinued within 2 weeks prior to enrollment. - Severe gastrointestinal dysfunction, gastrointestinal perforation, intraperitoneal abscess, and fistula. - Intestinal obstruction, signs and symptoms of intestinal obstruction, or the stent has been previously implanted and the stent has not been removed before the screening period. - Interstitial lung disease. - Tendency of arterial embolism and massive bleeding within 6 months before enrollment (except surgical bleeding). - Patients with fluid accumulation that couldn't reach a stable state but small amount of ascites on imaging without clinical symptoms could be enrolled. - Any serious or uncontrolled systemic disease, including uncontrolled high blood pressure, heart disease, active bleeding, active viral infection, etc. - Have had other malignancies within the past 5 years or currently, except cured cervical carcinoma in situ, uterine carcinoma in situ, and non-melanoma skin cancer. - Patients of childbearing age who refuse to take contraceptives, women who are pregnant or breastfeeding. - The researchers didn't consider it appropriate to participate in this study.

Gender: All

Minimum age: 18 Years

Maximum age: 85 Years

Healthy volunteers: No

Locations:

Facility:
Name: West China Hospital，Sichuan University

Address:
City: Sichuan
Zip: 610000
Country: China

Status: Recruiting

Contact:
Last name: Meng Qiu, MD

Phone: 028-85423203
Email: qiumeng33@hotmail.com

Start date: June 30, 2024

Completion date: December 2026

Lead sponsor:
Agency: West China Hospital
Agency class: Other

Source: West China Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06341296