cancer of unknown primary
Conditions
Interventions
treatment group:Sintilimab + bevacizumab +albumin-bound paclitaxel +carboplatin
Sponsors
The first Affiliated Hospital of Wenzhou Medicine University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent prior to the implementation of any trial-related procedures; 2. Male or female, age =18; 3. It is confirmed by pathological examination as metastatic, but the malignant tumor at the primary site cannot be determined after detailed examination and evaluation; 4. The patient has not received any anti-tumor therapy in the past, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc.; 5. ECOG score 0-1; 6. For adequate organ function, subjects must meet the following laboratory criteria: 1) In the past 14 days without the use of granulocyte colony-stimulating factor, the absolute value of neutrophil (ANC) was =1.2x109/L. 2) Platelet =75×109/L. 3) Hemoglobin =9g/dL in the case of no blood transfusion or use of erythropoietin in the past 7 days; 4) Total bilirubin =1.5× upper limit of normal (ULN); 5) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are =2.5×ULN 6) Serum creatinine =1.5×ULN and creatinine clearance (calculated by Cockcroft-Gault formula) =50 ml/min; 7) Good coagulation function, defined as International standardized ratio (INR) or prothrombin time (PT) =1.5 times ULN; 8) Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range.If baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled; 9) The myocardial enzyme profile is within the normal range (if the researchers comprehensively judge that the simple laboratory abnormality is not clinically significant, it is also allowed to be included) 7. For female subjects of reproductive age, a urine or serum pregnancy test should be performed negative within 3 days prior to receiving the first study drug administration (day 1 of cycle 1).If the urine pregnancy test results cannot be confirmed as negative, a blood pregnancy test is requested.Women of non-reproductive age were defined as at least one year after menopause or having undergone surgical sterilization or hysterectomy; 8. If there is a risk of conception, all subjects (male or female) are required to use contraception with an annual failure rate of less than 1% for the entire duration of treatment up to 120 days after the last study drug administration (or 180 days after the last chemotherapy drug administration).
Exclusion criteria
Exclusion criteria: 1. Is currently participating in an interventional clinical study treatment, or has received another investigational drug or used investigational devices in the 4 weeks prior to initial dosing; 2. Previous treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs that target another stimulus or synergistically inhibit T cell receptors (e.g. CTLA-4, OX-40, CD137); 3. There is active bleeding or abnormal coagulation function with bleeding tendency 4. History of hereditary bleeding tendency or thrombosis 5. Use adequate doses of anticoagulants or thrombolytic agents;Note: Prophylactic use of low-dose anticoagulants is permitted: prophylactic use of low-dose warfarin (=1mg/d), low-dose heparin (= 12,000 U/d) or low-dose aspirin (=100mg/d) is permitted under the precondition of INR =1.5. 6. Was receiving systemic glucocorticoid therapy (excluding topical glucocorticoids by nasal, inhalation, or other route) or any other form of immunosuppressive therapy within 7 days prior to the initial administration of the study;Physiological doses of glucocorticoids (=10 mg/ day of prednisone or equivalent) are permitted; 7. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 8. Patients who are known to be allergic to the active ingredients or excipients of sintilimab, bevacizumab, albumin-paclitaxel, carboplatin of the drugs in this study; 9. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive); 10. Received live vaccine within 30 days prior to the first dose (cycle 1, day 1); 11. Pregnant or lactating women; 12. Other situations deemed unsuitable for inclusion by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival,PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival 2 ,PFS 2;Objective Response Rate,ORR;Disease control rate,DCR;duration of response,DOR;Tumor remission depth;overall survival,OS; | — |
Countries
China
Contacts
Public ContactLI wenfeng
The first Affiliated Hospital of Wenzhou Medicine University
Outcome results
None listed