Personalized vaccine combined with third-line therapy for advanced colorectal cancer

A Multicenter Clinical Study of Personalized Tumor Neoantigen-based Peptide Vaccine Combined with Conventional Third-line Therapy for the Treatment of Colorectal Cancer Progressed After Second-line Treatment

This study is testing if a personalized vaccine, along with standard treatment, can help people with advanced colorectal cancer who haven't responded to previous therapies.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Nanchang University (other)
• Drugs / interventions: chemotherapy, prednisone
• Locations: 2 sites (Nanchang, Jiangxi and 1 other locations)
• Trial ID: NCT06751966 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness and safety of a personalized tumor neoantigen-based peptide vaccine combined with conventional third-line therapy in patients with colorectal cancer (CRC) who have progressed after second-line treatment. Ten participants will receive a tailored treatment plan that includes a series of subcutaneous vaccine injections and standard therapy over a 21-week period. The study will monitor various outcomes, including objective response rate, disease control rate, and overall survival, through regular follow-ups and assessments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with confirmed CRC who have experienced disease progression after second-line therapy.

Not a fit: Patients with CRC who have not progressed after second-line therapy or those with significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new treatment option for patients with advanced colorectal cancer who have limited alternatives.

How similar studies have performed: While the combination of immunotherapy and conventional treatments is being explored, this specific approach using personalized neoantigen vaccines in CRC is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* 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;
* Expected survival of ≥3 months;
* ECOG performance status of 0-1;
* Female patients of childbearing age must have a negative pregnancy test and be able to take effective contraceptive measures with no plans for pregnancy within six months of the study;
* Able to undergo all screening period laboratory tests as required by the protocol;
* Normal major organ function, such as heart, liver, and kidney;
* Hematologic parameters: neutrophil count ≥1.5×10\^9/L, hemoglobin ≥10g/dL, platelet count ≥100×10\^9/L, total bilirubin ≤1.5 times the upper limit of normal, AST and ALT ≤2.5 times the upper limit of normal, creatinine and blood urea nitrogen ≤1.5 times the upper limit of normal, activated partial thromboplastin time ≤1.5×ULN, and International Normalized Ratio or prothrombin time ≤1.5×ULN;
* No active hepatitis, AIDS, syphilis, or other infectious diseases;
* Rheumatoid panel: C-reactive protein (CRP) ≤10.0mg/L; Anti-streptolysin O (ASO) \<500U; Erythrocyte sedimentation rate ≤15mm/h (men) or 20mm/h (women);
* Thyroid function tests: 0.27mIU/L ≤ Thyroid-stimulating hormone (TSH) ≤ 4.2mIU/L; 3.1pmol/L ≤ Free triiodothyronine (FT3) ≤ 6.8pmol/L; 12pmol/L ≤ Serum free thyroxine (FT4) ≤ 22pmol/L; 1.3nmol/L ≤ Serum total triiodothyronine (TT3) ≤ 3.1nmol/L; 66nmol/L ≤ Serum total thyroxine (TT4) ≤ 181nmol/L;
* Adrenocorticotropic hormone (ACTH): 1.1-17.6pmol/L;
* Ability to understand and voluntarily sign a written informed consent form.

Exclusion Criteria:

Disease-specific exclusion criteria:

* 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.

Exclusion criteria for medical history and comorbidities:

* 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;
* Subjects participating in other clinical trials or whose first dose is less than 4 weeks (or 5 half-lives of the study drug) after the end of the previous clinical trial (last dose);
* Subjects with severe cardiovascular diseases, such as those meeting NYHA Class II or higher criteria, myocardial infarction, or cerebrovascular accidents (cerebral ischemia, symptomatic cerebral embolism, etc.) occurring within 3 months before the first dose, or unstable arrhythmias or unstable angina within 1 month before starting study treatment;
* Subjects with uncontrolled myocardial ischemia or myocardial infarction, poorly controlled arrhythmias are excluded;
* Subjects with hypertension that cannot be well controlled by antihypertensive medication (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg) (Note: a stable antihypertensive regimen should be in place within 1 week before the first dose);
* Subjects who have had significant clinically relevant bleeding symptoms or a clear bleeding tendency within 3 months before the first dose, as well as tumors that have invaded major blood vessels or, in the investigator's judgment, are highly likely to invade major blood vessels and cause major bleeding during treatment. Subjects with obvious hemoptysis, coughing up 2.5 mL or more of blood in the month before the first dose;
* Subjects who have experienced arterial/venous thrombotic events, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral embolism), deep vein thrombosis, and pulmonary embolism, within 3 months before screening;
* Subjects with active tuberculosis;
* Subjects who have had a serious infection within 4 weeks before the first dose, including but not limited to infections requiring hospitalization, bacteremia, severe pneumonia, etc.; Subjects with any active infection;
* Subjects preparing for or who have previously undergone tissue/organ transplantation;
* Subjects with uncontrolled epilepsy, central nervous system disorders, or neurological diseases resulting in cognitive impairment;
* Subjects with a history of splenectomy.

Other exclusion criteria:

* Pregnant or breastfeeding women;
* Subjects with a severe history of allergies or atopic constitution;
* Subjects with a history of chronic alcohol or drug abuse within 6 months before enrollment;
* Subjects deemed unsuitable for the study by the investigator.

Where this trial is running

Nanchang, Jiangxi and 1 other locations

• First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (RECRUITING)
• The First Hospital of Nanchang — Nanchang, Jiangxi, China (RECRUITING)

Study contacts

• Study coordinator: Yong Li, MD

Conditions: Colorectal Cancer, Tumor Neoantigen, Peptide Vaccine, Immunotherapy, Third-line Therapy