renal cancer
Conditions
Interventions
advanced/metastatic renal cancer:Nil
Sponsors
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Adult men and women, ages ranging from 18 to 75 years old; 2. Renal cell carcinoma confirmed by histology, or was unable to be operated on at the initial diagnosis or recurrence and metastasis after surgery; 3. In patients with renal cell carcinoma III-IV, at least one lesion can be measured by CT or MRI, or with clinically significant lesion that can be reliably monitored by researchers according to the RECIST v1.1; 4. Patients who have not received systemic antiangiogenic therapy before, including but not limited to: sunitinib, solafeni, pazopani, axitinib and bevacizumab, in advanced or metastatic state. Previous cytokine therapy (e.g. IL-2, interferon alpha), vaccine therapy, or cytotoxic treatment is permitted; 5. Patients with ECOG score less than or equal to 2; 6. According to the international model of metastatic renal cancer database, patients belong to the favorable, medium or poor risk group; 7. If the patients with brain metastasis have no symptoms, edema, without corticosteroids, radiotherapy / surgery or other active treatments, the inclusion conditions are met; 8. Patients with progress after radiotherapy. Systemic corticosteroids at palliative, local radiotherapy and immunosuppressive doses must be stopped at least 2 weeks before the first use of treprizumab, except that alternative organ therapy must be used (e.g. hydrocortisone and flutrexone); 9. The screening laboratory value must meet the following criteria (within 14 days before receiving the first trepril mAb): hemoglobin >=9.0 G/dl; neutrophils >=1500 cells/uL; platelets >=100x10^3/uL; total bilirubin 50ml / min (Cockcroft Gault equation) INR, APTT <=1.5 if urine protein is more than 1+, the urine protein should be collected for 24 hours, and the total amount should be 1 g or less; 10. Written informed consent signed and dated prior to any study specific procedures, sampling and analysis are required.
Exclusion criteria
Exclusion criteria: 1. Patients with any active autoimmune disease or a known history of autoimmune disease (with type I diabetes, hypothyroidism left due to the need for hormone replacement for autoimmune diseases, psoriasis without systemic treatment, or not expected to recur without external triggers, however, eligible to participate in this trial); 2. Patients with adrenal insufficiency; 3. Patients with HIV or HIV positive detection; 4. Hepatitis B virus surface antigen or hepatitis C virus RNA was detected positive, indicating active or chronic infection; 5. The patients had been targeted with anti PD-1, anti PD-L1, anti PD-L2, anti CD137, anti CTLA-4 antibody (or other co stimulation or checkpoint pathway for T cells) or TKI; 6. Within 4 weeks after the first study drug, any non-tumor vaccine treatment for infectious diseases, including seasonal (influenza) vaccine, was received; 7. Patients receiving cancer treatment must stop treatment at least 2 weeks before receiving the study drug. Besides local radiotherapy and corticosteroid replacement therapy, systemic hormone therapy and corticosteroid therapy should be stopped for at least 2 weeks. All adverse reactions to previous anti-cancer treatment, except for alopecia, must be at level 1 (CTCAE V5.0) or baseline before administration; 8. Patients with malignant tumor activity in the past 3 years, except locally cured cancers, such as basal cell or squamous cell skin cancer, superficial bladder cancer or prostate, cervical or breast in situ cancer; 9. Patients with hematopoiesis or organ function change meet the following criteria (evaluated within 14 days before the first administration): leukocyte is less than 2000/ µ L; polynuclear neutrophil is less than 1.5x10^9/l; platelet is less than 100x10^9/l; hemoglobin is less than 8.0 G/dl; alt/ast is greater than 3.0 ULN without liver metastasis, or 5 ULN in the case of liver metastasis; bilirubin is greater than 1.5 ULN (except for Gilbert syndrome: less than 3.0 mg/dl); creatinine clearance rate is 40 Ml / min or less (measured or calculated by Cockroft and Gault formula), or serum creatinine greater than 2.0 ULN; monoclonal antibody allergic to other active drugs or excipients; 10. Patients who have been treated with bone marrow stimulating factors such as CSF (colony stimulating factor) and EPO (erythropoietin) in the past 1 week; have received live vaccine treatment in the past 4 weeks; have received allogeneic hematopoietic stem cell transplantation or solid organ transplantation; have had major surgery (except diagnostic surgery) in the past 4 weeks; patients taking antibiotics and / or probiotics preparations in the past 8 weeks; 11. With history of drug abuse or psychodrug abuse; 12. Researchers believe that known or potential medical conditions (such as diseases related to diarrhea or acute diverticulitis) can cause risk to patients from taking the study drug, or obscure the interpretation of toxicity measurements or adverse events; 13. Researchers determined the history of uncontrolled epilepsy, central nervous system disorder or mental disorder with clinical significance, excluding informed consent or interfering with the compliance of oral drugs; 14. Unwilling to give written informed consent, participation or non-compliance with the study program during the study; 15. Deprived of his liberty or being corrected or bound by his act; 16. Using any other trial drug for treatment or participate in another clinical trial within 28
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Microbial diversity; | — |
Countries
China
Contacts
Public ContactWei Zhai
Shanghai Jiaotong University School of Medicine
Outcome results
None listed