This study is divided into two phases. The first phase aims to preliminarily evaluate the efficacy and safety of fruquintinib in combination with irinotecan liposome and capecitabine as second-line therapy for advanced metastatic colorectal cancer. The second phase is designed to further assess the efficacy and safety of fruquintinib in combination with irinotecan liposome and capecitabine compared to bevacizumab in combination with chemotherapy, also as second-line treatment for advanced metastatic colorectal cancer.
The first phase is a single-arm study, while the second phase is a randomized (1:1) controlled trial. Entry into the second phase is determined by the investigators based on the efficacy results from the first phase study: if the primary endpoint of progression-free survival (PFS) is met in the first phase, participants will proceed to the second phase study. In the second phase, randomization is stratified according to the RAS status and the presence of disease progression within six months of adjuvant or neoadjuvant therapy.
In the second phase, patients will be ramdomly assigned to receive fruquintinib(4mg/d, PO, D1-14, Q3W) in combination with irinotecan liposome(56mg/m2, ivgtt, D1, Q3W) and capecitabine(800mg/m2, PO, BID, D1-14, Q3W) or bevacizumab(7.5mg/kg, ivgtt, D1, Q3W) in combination with the same chemotherapy. Every three weeks is a cycle.
Patients voluntarily enrolled in the study and signed an informed consent form, were compliant and cooperated with follow-up visits;
Patients with metastatic colorectal adenocarcinoma confirmed by pathology or histology;
Age: 18-75 (inclusive of 18 and 75), male or female;
Patients who have previously failed or were intolerant to first-line standard therapy (recurrence within 6 months of the end of adjuvant chemotherapy is considered first-line treatment failure).
History of major surgery or severe trauma within 4 weeks prior to the initiation of the study drug.
Use of immunosuppressive agents, including systemic or locally absorbed corticosteroids, for immunosuppressive purposes, with a daily dose of prednisone >10 mg or equivalent, and continued us within 2 weeks prior to enrollment.
Prior exposure to any irinotecan-containing chemotherapy regimen.
Reception of live attenuated vaccines within 4 weeks prior to the initiation of the study drug.
Parallel
Fruquintinib+Irinotecan Liposome+Capecitabine
DrugStage 1: Participants received fruquintinib, irinotecan liposome, and capecitabine for 6-8 cycles. If no disease progression was observed after the initial treatment, patients were transitioned to maintenance therapy with fruquintinib and capecitabine. Stage 2: if the primary endpoint of progression-free survival (PFS) was met in the first stage, participants were eligible for the second stage. Participants were randomly assigned to two groups (A and B), Group A: Fruquintinib + irinotecan liposome + capecitabine. After 6-8 cycles of treatment, patients who had no disease progression were transitioned to maintenance therapy with Fruquintinib + capecitabine
Bevacizumab+Irinotecan Liposome+Capecitabine
DrugStage 2: if the primary endpoint of progression-free survival (PFS) was met in the first stage, participants were eligible for the second stage. Participants were randomly assigned to two groups (A and B), Group B: Bevacizumab + irinotecan liposome + capecitabine. After 6-8 cycles of treatment, patients who had no disease progression were transitioned to maintenance therapy with bevacizumab + capecitabine
Progression-free Survival (PFS)
time from randomization to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator
Objective Response Rate (ORR)
the proportion of patients with complete response or partial response, using RECIST v 1.1.
Disease Control Rate (DCR)
the proportion of patients with complete response, partial response or stable disease, using RECIST v 1.1.
Overall survival (OS)
time from randomization to death from any cause
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Liu Huang
Lead sponsor
Tongji Hospital
Sponsor institution
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