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A Clinical Study of Liposomal Irinotecan for Second-Line Therapy in Metastatic Colorectal Cancer

ConditionsMetastatic Colorectal Cancer (CRC)Liposomal IrinotecanSecond-Line
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHebei Medical University Fourth Hospital

About this trial

Phase II - Treatment Regimen Exploration Stage:

1. Evaluate the safety and efficacy of the following three treatment regimens:

Liposomal irinotecan + 5-FU/LV + bevacizumab + Enlonstobart (Group A) Liposomal irinotecan + 5-FU/LV + bevacizumab (Group B) Irinotecan + 5-FU/LV + bevacizumab (Group C) 2. Provide a basis for selecting the treatment regimen for the confirmatory phase. 3. Explore the relationship between tumor tissue, stool, and blood biomarkers and efficacy and adverse reactions in liposomal irinotecan combination regimens versus irinotecan combination regimens.

Phase III - Efficacy Confirmation Stage:

Compare the efficacy and safety of liposomal irinotecan combination regimens versus irinotecan combination regimens in second-line treatment of metastatic colorectal cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged ≥ 18 years old and ≤ 75 years old.

Histologically or cytologically confirmed metastatic colon or rectal adenocarcinoma;

Patients must have at least one measurable lesion according to RECIST 1.1 criteria.

Had received first-line treatment based on oxaliplatin.

Disqualifiers

Patients with a history of other malignancies within the past 5 years, except for cured carcinoma in situ or basal cell carcinoma of the skin.

Prior treatment with irinotecan or liposomal irinotecan-based chemotherapy, or prior treatment with immune checkpoint inhibitors (including but not limited to PD-1 inhibitors, PD-L1 inhibitors, and CTLA-4 inhibitors).

Patients with left-sided colorectal cancer, RAS/BRAF wild-type, who did not receive cetuximab in first-line therapy.

Patients with known mismatch repair dysfunction or microsatellite instability ;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Liposomal irinotecan + 5-FU/LV + bevacizumab + Enlonstobart

    Drug

    Irinotecan liposome: 70mg/m², intravenous infusion within 90 minutes; 5-FU: 400mg/m², intravenous injection followed by 2400mg/m² continuous intravenous infusion within 46 hours; LV: 400mg/m², intravenous infusion within 30 minutes; Bevacizumab: 5mg/kg, intravenous infusion within 30-90 minutes; Enlonstobart: 240mg, intravenous infusion for no less than 60 minutes;

  • Irinotecan liposome + 5-FU/LV + Bevacizumab

    Drug

    Irinotecan liposome: 70mg/m², intravenous infusion within 90 minutes; 5-FU: 400mg/m², intravenous injection followed by 2400mg/m² continuous intravenous infusion within 46 hours; LV: 400mg/m², intravenous infusion within 30 minutes; Bevacizumab: 5mg/kg, intravenous infusion within 30-90 minutes;

  • Irinotecan + 5-FU/LV + Bevacizumab

    Drug

    Irinotecan: 180mg/m², intravenous infusion within 90 minutes; 5-FU: 400mg/m², intravenous injection followed by 2400mg/m² continuous intravenous infusion within 46 hours; LV: 400mg/m², intravenous infusion within 30 minutes; Bevacizumab: 5mg/kg, intravenous infusion within 30-90 minutes;

Treatment groups

408 Participants
are divided into 3 treatment groups
Group A: Group AExperimental treatment 1 intervention
Group B: Group BExperimental treatment 1 intervention
Group C: Group CActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

ORR

Time frame
Around 4 years

Secondary outcomes

1

DCR

Time frame
Around 4 years
2

DoR

Time frame
Around 4 years
3

PFS

Time frame
Around 4 years
4

OS

Time frame
Around 4 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hebei Medical University Fourth Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: