Advanced malignant tumor
Conditions
Interventions
Single arm group:CDP1 combined with LDP
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Informed consent is required for this study, and a written informed consent is voluntarily signed; 2. Aged >= 18 years old; 3. Locally advanced or metastatic malignant tumor confirmed by histopathology, failed standard treatment, has no standard treatment plan or is not suitable for standard treatment at this stage; 4. The expected survival time is more than 3 months; 5. At least one measurable tumor lesion (solid tumors according to RECIST 1.1 criteria, see Appendix 1 for details) 6. ECOG physical fitness score 0-2 points; 7. No serious abnormal blood system, liver function, renal function and coagulation function: absolute neutrophil count >=1.5x10^9/L; hemoglobin >=9 g/dL; platelet count >=75x10^9/L ; Serum total bilirubin=50 mL/min (calculated according to Cockroft-Gault formula); Urine protein <=2+; or 24-hour urine protein quantification <=1g; prothrombin time (PT) <=1.5xULN: international normalized ratio (INR) <=1.5xULN; partially activated prothrombin time (APTT) <=1.5xULN; 8. Females of childbearing age should have negative blood or urine pregnancy test results within 7 days before taking the drug for the first time. Male subjects and female subjects of childbearing age must take adequate contraceptive measures from the time of signing the informed consent of the study to 3 months after the last study drug treatment, and there is no plan to donate sperm or eggs.
Exclusion criteria
Exclusion criteria: 1. Received chemotherapy, biological therapy, radiation therapy, endocrine therapy, small molecule targeted therapy and other anti-tumor therapy within 4 weeks before starting the study drug (except for oral nitrosoureas, mitomycin C and fluorouracil) Drugs): nitrosoureas or mitomycin C for 6 weeks; oral fluorouracil drugs, such as Sigiol, capecitabine, the interval between the last oral drug and the use of the study drug is at least 2 weeks; Received macromolecular antitumor drugs with longer half-life within 8 weeks before enrollment; 2. Previous use of anti-PD-L1 inhibitors; 3. Patients who have not seen clinical benefit during the previous treatment with PD-1 or anti-EGFR monoclonal antibody (definition of clinical benefit: during the previous treatment of similar drugs, no drug discontinuation due to allergic reactions or infusion reactions, PFS at least More than 3 months, and combined with the judgment of the investigator); 4. Less than 6 months from the last treatment of anti-PD-1 monoclonal antibody or anti-EGFR monoclonal antibody to enrollment; major organ surgery (excluding needle biopsy) or severe trauma within 4 weeks before the first dose; 5. Received major organ surgery (excluding needle biopsy) or suffered severe trauma within 4 weeks before the first administration; 6. The adverse reactions of previous anti-tumor therapy have not recovered to CTCAE 5.0 grade evaluation =3 have occurred in immunotherapy in the past; 9. Patients with active or previous autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, interstitial lung disease, etc.); 10. Patients who have received systemic corticosteroids (prednisone>10mg/day or equivalent dose of similar drugs) or other immunosuppressive therapy within 14 days before the first dose; except for the following cases: treatment with topical corticosteroids ( ophthalmic, intra-articular, intranasal, and inhaled steroids); short-term corticosteroids for prophylaxis; 11. Active malignant tumor within the past two years (except for tumors targeted by this study, cured stage IB or lower-grade cervical cancer, non-invasive basal cell or squamous cell skin cancer, complete remission ( CR)> 10 years of malignant melanoma, except for other malignant tumors with complete remission (CR)> 5 years); 12. Uncontrolled active hepatitis B (HBsAg positive and HBV DNA copy number > 103/mL or HBV DNA titer > 200 IU/mL); hepatitis C; syphilis infection (syphilis antibody positive) and HIV test positive patients . 13. History of serious cardiovascular disease: including ventricular arrhythmia requiring clinical intervention; acute coronary syndrome, congestive heart failure, stroke or other grade 3 or above cardiovascular events within 6 months; New York, USA Cardiac Association (NYHA) cardiac function class >= grade II or left ventricular ejecti
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Event;Dose Limited Toxicity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Duration of Response;Disease Control Rate;Progress Free Survial;Pharmacokinetics;Anti-Drug Antibody;Circulation immunity compound; | — |
Countries
China
Contacts
Public ContactWang Yongsheng
West China Hospital of Sichuan University
Outcome results
None listed