Dose Escalation and Expansion Clinical Trial of Irinotecan Liposome Combined With Oxaliplatin and 5-FU/LV Plus Bevacizumab as First-line Treatment of Metastatic Colorectal Cancer

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

Dose escalation clinical trial: To explore the dose limiting toxicity (DLT) of irinotecan liposome injection combined with oxaliplatin +5-FU/LV+ bevacizumab in first-line treatment of patients with advanced metastatic colorectal cancer, and to estimate the maximum tolerated dose (MTD) of combined administration. Expansion clinical trial: To evaluate the safety and efficacy of irinotecan liposome injection combined with oxaliplatin +5-FU/LV+ bevacizumab or cetuximab in first-line treatment of patients with advanced metastatic colorectal cancer. Exploratory analysis of ctDNA changes and genetic mutations in patients at baseline.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 18-75 years old.

• Histopathologically confirmed patient with an inoperable metastatic colorectal adenocarcinoma.

• 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 12 months removed from the date of last administration of neoadjuvant or adjuvant therapy.

• The presence of at least 1 measurable lesion that can be evaluated according to the RECIST v1.1 criteria.

• ECOG 0

• Normal bone marrow and organ function: ① Neutrophils (ANC) ≥1.5×10\^9/L, platelets (PLT) ≥100×10\^9/L, hemoglobin (Hb) ≥90g/L, white blood cells (WBC) ≥3.0×10\^9/L, albumin (ALB) ≥35 g/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.

Locations
Other Locations
China
Zhongshan Hospital Affiliated to Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Tianshu Liu, Doctor
liu.tianshu@zs-hospital.sh.cn
+861368 1973 996
Time Frame
Start Date: 2024-03-11
Estimated Completion Date: 2026-05-01
Participants
Target number of participants: 78
Treatments
Experimental: irinotecan liposome injection combined with oxaliplatin +5-FU/LV+ bevacizumab or cetuximab
In dose escalation study, patients will be treated with irinotecan liposome injection combined with oxaliplatin +5-FU/LV+ bevacizumab. In expansion study, patients will be treated with irinotecan liposome injection combined with oxaliplatin +5-FU/LV+ bevacizumab or cetuximab, depending on their baseline mutation status. Oxaliplatin is accepted up to 12 cycles.
Related Therapeutic Areas
Sponsors
Collaborators: CSPC Ouyi Pharmaceutical Co., Ltd.
Leads: Shanghai Zhongshan Hospital

This content was sourced from clinicaltrials.gov

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