About this trial
In this study, the investigators provide a combined treatment of personalized tumor neoantigen-based peptide vaccine and conventional third-line therapy to patients with colorectal cancer (CRC) progressed after second-line treatment. The investigators observe the objective response rate (ORR), disease control rate (DCR), adverse event (AE), serious adverse event (SAE), progression-free survival (PFS), and overall survival (OS) , aiming to evaluate the effectiveness and safety of the treatment.
Eligibility criteria
Qualifiers
Patients with histologically or cytologically confirmed CRC;
At least one measurable lesion;
Aged 18-70, regardless of gender;
Disease progression after standard second-line therapy, and more than 2 weeks since the end of the last antitumor treatment;
Disqualifiers
Patients with uncontrollable brain metastases;
Subjects expected to require any form of antitumor treatment during the study, including maintenance therapy with other drugs, chemotherapy, and/or surgical resection.
Subjects who have required systemic treatment with corticosteroids (>10 mg/day of prednisone or equivalent) or other immunosuppressants within 14 days before the first dose. Inhalational or topical corticosteroids are allowed in the absence of active autoimmune diseases;
Subjects who have been treated with anticancer immunotherapies or other immunostimulatory anticancer drugs (interferons, interleukins, thymosin, immune cell therapy, etc.) within 3 months before the first dose;
Trial design
Treatments tested in this trial
- Combination Product: Conventional third-line therapy
- Neoantigen-based peptide vaccine