The goal of this clinical trial is to explore the preliminary efficacy and tolerability of Aipalolitovorelizumab (QL1706) in combination with fruquintinib for the treatment of metastatic colorectal cancer patients with immunodominant pMMR/MSS type who have failed second-line or above treatment. It is an open-label, single-arm, single-center phase II trial. The main questions it aims to answer are:
What is the objective response rate (ORR) of this combination therapy? What are the outcomes in terms of progression-free survival (PFS), overall survival (OS), and disease control rate (DCR)? What are the safety profiles and tolerability of the treatment?
Participants will receive:
Aipalolitovorelizumab (QL1706) injection at a dose of 5mg/kg, administered intravenously on Day 1 of each 3-week treatment cycle.
Fruquintinib at a dose of 5mg per day, taken orally continuously for the first 2 weeks of each 3-week cycle, followed by 1 week of withdrawal.
The treatment will continue until disease progression as assessed by RECIST v1.1 criteria, occurrence of unacceptable toxicity, decision to withdraw by the doctor or patient, non-compliance, or discontinuation due to administrative reasons. Participants will be monitored throughout the trial period to evaluate the efficacy and safety of the treatment.
Have a full understanding of this study and voluntarily sign the informed consent form;
Aged 18 - 75 years;
Patients must be pathologically confirmed as advanced, metastatic or recurrent microsatellite stable (MSS) colorectal cancer (detected by immunohistochemistry, PCR or NGS according to the detection standards of each institutional testing center);
The results of patients' genetic testing show no POLD1/POLE mutations;
Unable to comply with the study protocol or research procedures;
Pregnant or lactating women;
Any factors affecting oral administration;
Patients who have previously received immunotherapy and fruquintinib;
Single group
Aipalolitovorelizumab
DrugAipalolitovorelizumab (QL1706) injection at a dose of 5mg/kg, administered intravenously on Day 1 of each 3-week treatment cycle.
Fruquintinib
DrugFruquintinib at a dose of 5mg per day, taken orally continuously for the first 2 weeks of each 3-week cycle, followed by 1 week of withdrawal.
Objective Response Rate
Objective Response Rate (ORR) refers to the proportion of patients who achieve complete response (CR) and partial response (PR) after treatment among the total number of evaluable patients.
Progression Free Survival
Progression-Free Survival (PFS) refers to the time from the start of receiving treatment to the occurrence of objective tumor progression or the patient's death.
Overall survival
Overall survival defined as the time between signing the informed consent form to death due to various causes
Disease Control Rate
Disease Control Rate defined as the proportion of patients who achieved complete response (CR), partialresponse (PR), and stable disease (SD) according to RECIST v1.1.
Safety
Use NCl-CTCAE version 5.0 for classification and grading
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This trial is not recruiting at the moment. You can still explore other options:
