RecruitingPhase 1NCT06225622

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


Sponsor

Shanghai Zhongshan Hospital

Enrollment

78 participants

Start Date

Mar 11, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of four chemotherapy drugs — a liposomal form of irinotecan, oxaliplatin, 5-FU/leucovorin, and bevacizumab — as a first-line treatment for metastatic colorectal cancer (cancer that has spread to other organs). **You may be eligible if...** - You are between 18 and 75 years old - You have metastatic colorectal cancer confirmed by biopsy that cannot be surgically removed - You have not yet received any systemic cancer treatment for your metastatic disease - If you had prior neoadjuvant or adjuvant chemotherapy, it was completed at least 12 months before your disease came back - Your cancer is measurable on imaging - Your overall performance status is excellent (ECOG 0) - Your blood counts, liver, and kidney function are adequate **You may NOT be eligible if...** - You have MSI-H or dMMR cancer and are a candidate for immunotherapy - You have previously received irinotecan - You are underweight (BMI under 18.5) - You have brain metastases - You have had recent major surgery or untreated gastrointestinal problems - You have interstitial lung disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIrinotecan Liposome

In dose escalation study, irinotecan liposome injection will be administered by an intravenous infusion at three doses of 60 mg/m2, 70 mg/m2 and 80 mg/m2, d1, 14 days per cycle. In expansion study, irinotecan liposome injection will be administered by an intravenous infusion at the dose of RP2D, d1, 14 days per cycle. Until the disease progresses or surgery is possible.

DRUGOxaliplatin

85 mg/m2, intravenously infusion, d1, 14 days per cycle, up to 12 cycles.

DRUG5-FU

2400mg/m2, intravenous infusion, d1-2, 14 days per cycle. Until the disease progresses or surgery is possible.

DRUGLV

400mg/m2, intravenous infusion, d1, 14 days per cycle. Until the disease progresses or surgery is possible.

DRUGBevacizumab

5mg/kg, intravenous infusion, d1, 14 days per cycle. Until the disease progresses or surgery is possible.It is used to patients in dose escalation phase and with gene mutation in extension phase.

DRUGCetuximab

500mg/m2, intravenous infusion, d1, 14 days per cycle. Until the disease progresses or surgery is possible.For wild-type patients in extended phase studies.


Locations(1)

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

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NCT06225622


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