Solid tumors with Genomic instability
Conditions
Interventions
Case series:Personalized neoantigen peptides and Immune adjuvant
Sponsors
Chongqing Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. The patients volunteer to join in the trial and sign the informed consents; 2. Male and female patients aged 18 to 70 years old; 3. Advanced solid tumors(Ovarian cancer, bladder cancer, breast cancer, cervical cancer, endometrial cancer, melanoma) patients with genomic instability who have experienced disease progression or intolerance after surgery, targeted therapy, or chemoradiotherapy and lack of further effective treatment methods based by high-level evidence, or who have no corresponding recommended treatment in the diagnostic guidelines; 4. Sufficient tumor tissues and peripheral blood samples can be obtained for whole exon and transcriptome sequencing; 5. The last surgical treatment was more than 3 months,the last local ablation or radiotherapy was more than 4 weeks, and the last chemotherapy was more than 3 months;?Judged as disease progression after evaluation; 6. No anti-tumor or immunoenhancement therapy within 8 weeks before the start of study therapy and during the observation period; 7. With at least one measurable lesion for therapeutic evaluation; 8. Expected survival time is 6 months or longer; 9. The ECOG score is 0 or 1; BMI>=16; 10. Genomic instability: TMB>=10 or MSI-H; 11. Bone marrow functionplatelet counts>=90x10^9/L; hemoglobin >90g/LWBC counts>=3x10^9/L, hemoglobin >8.0g/dl, neutrophil counts >=1.5x10^9/L; Liver functionSerum creatinine =28g/L; Kidney function:serum creatinine =50 ml/min; 12. Adequate contraception before enrollment and throughout the study period up to 3 months after the last injection.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Allergic to synthetic peptides or GM-CSF; 3. No suitable neoantigens are screened through comprehensive bioinformatics analysis; 4. Participated in another clinical trial within 4 weeks prior to enrolling in the study, or intended to participate in another clinical trial throughout the study; 5. Received any gene therapy; 6. Uncontrolled active infection;?History of human immunodeficiency virus(HIV);Active HBV or HCV infection; 7. Grade 2-4 acute or systemic chronic graft-versus-host disease(GVHD);GVHD under treatment; 8. Undergoing long-term treatment with anticoagulants or serious medical problems; 9. Absolute neutrophils count<750/µL or platelets count<50,000/µL caused by a non-primary disease; 10. Uncontrolled brain metastasis with clinical symptoms;Having definite neurological/psychiatric disorder, or previously been diagnosed with epilepsy; 11. Other circumstances that the investigator considered not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective reponse rate;Duration of response;Over survival;Immunological index;Progress-free survival;One-year survival rate; | — |
Countries
China
Contacts
Public ContactWeiqi Nian; Qi Zhou
Chongqing Cancer Hospital
Outcome results
None listed