Phase II Study of Irinotecan Liposomes Combined With 5-FU/LV+ Bevacizumab in First-line Treatment of Metastatic Colorectal Cancer

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
West China Hospital,Sichuan University
RECRUITING
Sichuan
Contact Information
Primary
Meng Qiu, MD
qiumeng33@hotmail.com
028-85423203
Time Frame
Start Date: 2024-06-30
Estimated Completion Date: 2026-12
Participants
Target number of participants: 86
Treatments
Experimental: irinotecan liposome injection combined with 5-FU/LV+ bevacizumab
Patients will be treated with irinotecan liposome injection combined with 5-FU/LV+ bevacizumab. Treatment lasted 8 cycles.
Related Therapeutic Areas
Sponsors
Leads: West China Hospital

This content was sourced from clinicaltrials.gov

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