solid tumor
Conditions
Interventions
Treatment until disease progression or intolerable toxicity, subject withdraws ICF (up to 2 years)
Sponsors
Affiliated Hospital of Jiangnan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Age >=18 years, regardless of gender; (2) Enrolled patients must be eligible for advanced solid tumors with pre-existing recurrence or metastasis; (3) Prior progression on standard first-line systemic therapy; (4) Eastern Cooperative Oncology Group (ECOG) score of 0-3 and expected survival >3 months; (5) Have at least one measurable lesion according to the criteria for evaluating efficacy in solid tumors (RECIST 1. 1); (6) No history of immunologic disease; (7) Basically normal hematological parameters: white blood cell count>=4×109/L; absolute neutrophil count >=1.5×109/L; platelets>=100×109/L; hemoglobin >=90 g/L; (8) Renal function is basically normal: serum creatinine = 60 mL/min; (9) Substantially normal liver function: serum total bilirubin <=1.5 × ULN (<=3.0 × ULN if liver metastases are present); azelotransferase (AST) and alanine transaminase (ALT) <= 2.5 × ULN (<=5.0 × ULN if liver metastases are present); (10) Female patients must have a negative urine pregnancy test prior to study entry (not applicable to patients with bilateral oophorectomy and/or hysterectomy or postmenopausal patients); (11) Signed written informed consent and be able to comply with the protocol during the study.
Exclusion criteria
Exclusion criteria: (1) Patients with any active autoimmune disease or history of autoimmune disease (e.g., the following, but not limited to: autoimmune hepatitis, interstitial pneumonitis, uveitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, nephritis, and hyperthyroidism; patients with vitiligo; patients with asthma that has resolved completely in childhood and does not require any intervention in adulthood; patients with asthma that requires bronchodilator therapy; and patients with asthma that requires medical intervention. patients with asthma requiring medical intervention with bronchodilators could not be included) (2) Participation in another interventional clinical trial within 30 days prior to screening; (3) Patients who are on immunosuppressive, or systemic hormone therapy for immunosuppression (dose >10 mg/day prednisone or other equipotent hormone) and continue to do so within 2 weeks prior to enrollment; (4) Presence of poorly controlled co-morbidities (e.g., heart failure, diabetes mellitus, hypertension, thyroid disease, psychiatric disorders, etc.); (5) Known infectious diseases such as HIV infection or active viral hepatitis; (6) Hypersensitivity to the drugs used in this regimen or their components; (7) Grade =2 peripheral neuropathy or hearing loss according to the criteria of the Common Terminology for Adverse Events (NCI CTCAE V5.0); (8) Pregnant (confirmed by blood or urine HCG testing) or lactating women, or subjects of childbearing potential who are unwilling or unable to use effective contraception (for both male and female subjects) until at least 6 months after the last trial treatment; (9) Persons who, in the opinion of the Investigator, are not suitable for participation in this study; (10) Unwilling to participate in the study or unable to sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival;overall survival;9/12-month overall survival rate;Disease control rates;Quality of Life;Safety; | — |
Countries
China
Contacts
Public ContactJianfeng Huang
Affiliated Hospital of Jiangnan University
Outcome results
None listed