Clinical Study of Irinotecan Liposome (II)-Based Combination Treatment for Irinotecan-resistant Colorectal Cancer.

Sponsor
Chinese PLA General Hospital
Study ID
NCT07044921
Phase
PHASE2
Status
Recruiting
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Conditions

  • Colorectal Cancer Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan Liposomes (II)+Cetuximab+Bevacizumabl — DRUG
    Irinotecan Liposomes (II) injection：Intravenous infusion, 60 mg/m2, Day 1, Q2W. The recommended initial dosage of irinotecan liposomes (II) for patients with the UGT1A1 \* 28/\* 6 homozygous mutation is 47.1 mg/m2. Cetuximab injection：Intravenous infusion, 500 mg/m2, Day 1, Q2W. Bevacizumabl: Intravenous infusion, 5mg/kg, Day 1, Q2W.

Study Details

Phase II clinical study of irinotecan liposome (II)-based combination regimen as a treatment for irinotecan-resistant colorectal cancer.

Key Dates

Start date
Sep 1, 2024
Status verified
Jun 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Irinotecan Liposomes (II)+Cetuximab+Bevacizumabl
    Irinotecan Liposomes (II)，Cetuximab and Bevacizumabl injection was started on Day 1 of each cycle.Combined treatment for 2 weeks, after efficacy evaluation, the investigator decides the subsequent treatment regimen, or until disease progression, toxicity intolerance, initiation of new anti-tumor therapy, withdrawal of informed consent, or the investigator judges that the subject needs to withdraw from the study treatment. Following RECISTv1.1 defined progression (as assessed by the investigator), study drug may continue if the investigator assesses that the subject is still receiving clinical benefit and tolerates study treatment.

Primary Outcome Measure

PFS [ Time Frame: up to 3 years ]

Central Contacts

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