Personalized cancer vaccine combined with anti-PD-1 and radiofrequency ablation for advanced solid tumors

Safety, Tolerability and Immunogenicity of a Personalized Neoantigen Cancer Vaccine Combined With Anti-PD-1 and Radiofrequency Ablation in Patients With Advanced Solid Tumors

This study is testing a personalized cancer vaccine combined with a common treatment and a special heat technique to see if it helps people with advanced solid tumors fight their cancer better.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sir Run Run Shaw Hospital (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT04864379 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates a personalized neoantigen cancer vaccine, iNeo-Vac-P01, in combination with anti-PD-1 antibody and radiofrequency ablation for patients with advanced malignant solid tumors. The primary goal is to assess the safety, tolerability, and immunogenicity of this treatment approach. By targeting unique mutations in tumor cells, the vaccine aims to stimulate the immune system to combat cancer recurrence. Participants will receive the vaccine alongside standard treatments to determine its effectiveness and safety profile.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 75 with advanced solid tumors who have failed or are unsuitable for standard treatments.

Not a fit: Patients with early-stage tumors or those who have not yet undergone standard treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a novel personalized treatment option that enhances the immune response against advanced solid tumors.

How similar studies have performed: Other studies have shown promise with personalized cancer vaccines, but this specific combination approach is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Must freely sign informed consent;
2. Aged 18 to 75 years old;
3. Life expectancy of greater than 3 months.
4. At least one measurable lesion according to RECIST 1.1 criteria(Radiofrequency ablation of lesions was excluded).
5. histologically confirmed Advanced solid tumors,
6. have failed standard treatment, or unsuitable to receive standard treatment
7. Liver metastases are present and are suitable for radiofrequency ablation；
8. agreeable to allow tumor and normal samples to be submitted for complete exome and transcription sequencing.
9. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
10. Good hematopoietic function ， defined as absolute neutrophils count ≥1.5×109 /L, platelet count ≥100 ×109 /L, and hemoglobin ≥90g/L；
11. Good liver function, defined as total bilirubin levels ≤1.5 times the upper normal limit (ULN), and glutamic-oxalacetic transaminase (AST) and glutamic-pyruvic transaminase (ALT) levels ≤5 times ULN;
12. Good renal function, defined as serum creatinine ≤1.5 times ULN or calculated creatinine clearance ≥ 60 mL /min (Cockcroft-Gault formula); Routine urine examination urine protein less than 2+, or 24 hours urine protein quantitative \<1g;
13. Good coagulation function, defined as INR or prothrombin time (PT) ≤1.5 times ULN; If the subject is receiving anticoagulant therapy, PT is acceptable as long as it is within the range of anticoagulant drug use；
14. Pregnant, lactating women and women of child-bearing age must have a negative pregnancy test within 7 days before entering the group, and short-term have no fertility plan, and are willing to take protective measures (contraception or other birth control methods) before and during the clinical trial;

Exclusion Criteria:

1. Currently participating in an interventional clinical study treatment or has received other investigational drugs or used investigational devices within 4 weeks prior to the first administration;
2. Major surgical treatment within 3 weeks prior to first administration;
3. Completed palliative radiotherapy within 7 days prior to first administration;
4. Clinical active diverticulitis, abdominal abscess, and gastrointestinal obstruction;
5. Have none suitable neoantigen;
6. Have been bone marrow or stem cell transplants;
7. Clinically uncontrollable pleural effusion/peritoneal effusion/pericardial effusion;
8. Severe known allergic reactions (≥ grade 3) to the active ingredient and/or any excipient of PD-1 monoclonal antibody；
9. Active autoimmune disease requiring systemic treatment occurred within 2 years prior to initial administration；
10. Diagnosed with immunodeficiency or was receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dosing of the study；
11. Full recovery from toxicity and/or complications associated with any intervention has not been achieved prior to the commencement of treatment；
12. Other tumors diagnosed within 5 years prior to initial administration, exceptions include radical basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radical resection of carcinoma in situ;
13. Symptoms of central nervous metastasis
14. A history of noninfectious pneumonia requiring glucocorticoid therapy or current interstitial lung disease within 1 year prior to initial administration;
15. Active infections that require systemic treatment;
16. A known presence of mental illness or substance abuse conditions that may affect compliance with the test requirements;
17. Human immunodeficiency virus (HIV) infection；
18. Untreated active hepatitis B；
19. Active subjects with HCV infection；
20. vaccine was administered within 30 days prior to initial administration (cycle 1, day 1)；
21. Medical history or evidence of disease, abnormal values of treatment or laboratory tests, or other conditions deemed inappropriate by the Investigator to interfere with the results of the study, prevent subjects from participating fully in the study;
22. breastfeeding women. Patients with previous and current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe pulmonary impairment, etc.;
23. Patients whose cardiopulmonary function cannot tolerate anesthesia；
24. The investigator evaluates other circumstances that may affect the conduct of the clinical study and the judgment of the study results.

Where this trial is running

Hangzhou, Zhejiang

• Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Fang Yong, MD, PhD

Conditions Advanced Malignant Solid Tumor