locally advanced or metastatic renal cell carcinoma
Conditions
Interventions
treatment group:Camrelizumab combined with Apatinib
Sponsors
Sun Yat-Sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or female patient greater than 18 years of age; 2. Subjects should have Eastern Cooperative Oncology Group (ECOG) status 0-1; 3. Subjects must have histologically confirmed unresectable, locally advanced (defined as disease not eligible for curative surgery or radiation therapy) or metastatic RCC with a clear-cell carcinoma component; 4. Disease had progression or intolerance after previous treatment with TKI; 5. At least 1 site of measurable disease by the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST version 1.1) guidelines; 6. He life expectancy is more than or equal to 12 weeks; 7. Functions of major organs: No significant abnormalities are found in liver, kidney, bone marrow, heart and other important organs; 8. Women of childbearing age must confirm non-pregnancy prior to enrollment. All enrolled subjects (male and female) must take adequate barrier methods for birth control during the entire treatment period and within 4 weeks after the end of treatment; 9. The subject must be capable of understanding and voluntarily signing the informed consent. The informed consent must be signed prior to any tests.
Exclusion criteria
Exclusion criteria: 1. Women in pregnancy or lactation; 2. History of severe hypersensitivity reaction to the active ingredients and/or any excipients of the study drug; 3. Known active central nervous system (CNS) metastases and/or carcinomatous meningitis; 4. Other malignant tumors which have not been cured before 5 years; 5. Those who received strong CYP3A4 inhibitor treatment within one week before enrollment, or who received strong CYP3A4 inducer treatment within 2 weeks before participating in the study;6.People with high blood pressure who cannot be well controlled by single antihypertensive drugs; 7. Had arterial/venous thrombotic events within 6 months before enrollment; 8. Uncontrolled clinical symptoms or diseases of the heart; 9. Previously received first-line or above systematic treatment for metastatic renal cancer: targeted drug/immune/cytokine therapy, and the efficacy evaluation has been conducted; 10. A serious infection occurred within 4 weeks before the first use of study drug(>2 Grade); 11. A documented history of clinically severe autoimmune disease, or a syndrome that requires systemic or immunosuppressive agents; 12. HIV positive, or other immune deficiencies; patient who need to take large doses of hormones for a long time; 13. Have a history of interstitial lung disease and a history of non-infectious pneumonia; 14. Untreated active hepatitis; 15. History of psychotropic substance abuse, alcohol and drug abuse; 16. Any condition that is not stable or may jeopardize the safety of the subject and his/her compliance with the study; or other factors that the investigators believe that the subject is not suitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease control rate;Overall survival;Duration of response; | — |
Countries
China
Contacts
Public ContactFangjian Zhou, Pei Dong, Xiuyu Cai
Sun Yat-Sen University Cancer Center
Outcome results
None listed