Exploratory Study of Irinotecan Liposomes in Maintenance Therapy of Metastatic Colorectal Cancer

Trial Title: Exploratory Study of Irinotecan Liposomes in Maintenance Therapy of Metastatic Colorectal Cancer

NCT ID: NCT06341309

Condition: Metastatic Colorectal Cancer

Conditions: Official terms:
Colorectal Neoplasms
Bevacizumab
Irinotecan

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Not yet 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. Until the disease progresses, intolerable toxicity occurs, and the patient withdraws informed consent (whichever comes first).
Arm group label: irinotecan liposome injection combined with bevacizumab

Intervention type: Drug
Intervention name: Bevacizumab
Description: 5mg/kg, d1, 14 days per cycle. Until the disease progresses, intolerable toxicity occurs, and the patient withdraws informed consent (whichever comes first).
Arm group label: irinotecan liposome injection combined with bevacizumab

Summary: To evaluate the progression-free survival (PFS1), objective response rate (ORR), disease control rate (DCR), progression-free survival from first-line treatment initiation (PFS2), overall survival (OS), and safety of irinotecan liposome combined with bevacizumab in patients with advanced metastatic colorectal cancer.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - 18~85 years old. - Histopathologically confirmed patient with an inoperable metastatic colorectal adenocarcinoma. - pMMR or MSS. - CR, PR, or SD (according to RECIST v1.1 criteria) achieved after 12-16 weeks of intensive treatment with a first-line chemotherapy regimen containing irinotecan/fluorouracil or a three-drug chemotherapy regimen containing oxaliplatin/irinotecan/fluorouracil plus bevacizumab. - If previously received neoadjuvant or adjuvant therapy, the time interval between initiation of systemic first-line therapy and the date of last dosing must be at least 6 months. - ECOG 0~1, patients ≥75 years old need an ECOG score of 0. - Normal bone marrow and organ function: ① Neutrophils (ANC) ≥1.5×10^9/L, platelets (PLT) ≥75×10^9/L, hemoglobin (Hb) ≥85g/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 ≥60 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. - Had received surgery or other treatment for tumors other than intensive treatment (including chemotherapy, radiotherapy, research treatment, etc., within 4 weeks prior to enrollment, if the interval between the current treatment was longer than 5 drug half-lives, could be included). - Previous treatment-related toxicity did not return to NCI-CTCAE v5.0 I or below (except for alopecia, 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. - The presence of severe gastrointestinal dysfunction or 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

Start date: August 9, 2024

Completion date: August 1, 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/NCT06341309