a study of ak104 plus axitinib in advanced/metastatic special pathological subtypes of renal cell carcinoma

Conditions: Renal Cell Carcinoma; First-line Treatment; Non Clear Cell Renal Cell Carcinoma; Sarcomatoid Renal Cell Carcinoma

Summary: this is a phase ib/ii, open-label, single arm trial to evaluate the efficacy and safety of ak104 in combination with axitinib as a first-line treatment for advanced/metastatic special pathological subtypes of renal cell carcinoma (ssrcc). subjects will receive ak104 plus axitinib until disease progression, development of unacceptable toxic effects, death, a decision by the physician or patient to withdraw from the trial. the primary endpoint is orr and pfs per recist v1.1 and imrecist as assessed by investigators.


Eligibility criteria:
inclusion criteria: 1. age≥18, ≤75; 2. histology characteristics accord with special pathological subtypes of rcc: papillary renal cell carcinoma, chromophobic cell carcinoma, tfe3 rearrangement renal cell carcinoma, fh-deficient renal cell carcinoma, collecting duct carcinoma, medullary carcinoma, sarcomatoid carcinoma (\>10%), unclassified renal cell carcinoma ; 3. metastatic renal cell carcinoma (tnm iv stage according to the 2009 tnm staging system). 4. patients who have not previously received systemic therapy, ecog (eastern cooperative oncology group)≤2; 5. expected survival \>3 months; 6. all patients signed informed consent. 7. blood routine indexes: neutrophils ≥1.5\*109, platelets ≥100\*109, hemoglobin ≥90g/l; 8. liver function: bilirubin ≤ normal upper limit 1.5 times, alt/ast≤ normal upper limit 2.5 times;serum creatinine ≤ 1.5 times of normal upper limit 9. the following diseases did not appear within 12 months: myocardial infarction, severe or unstable angina pectoris, asymptomatic heart failure, cardiovascular and cerebrovascular accident or transient ischemic attack, etc. exclusion criteria: 1. other malignancies previously or at the same time that are different from the primary site or histology of the tumor assessed in this study, except cervical carcinoma in situ, basal-cell carcinoma that has been fully treated, superficial bladder tumor (ta, tis, t1) or other malignancies that occurred before the enrollment and have been cured for more than 3 years; 2. renal decompensation requires hemodialysis or peritoneal dialysis; 3. arrhythmia need anti-arrhythmic treatment, symptomatic coronary artery disease or myocardial ischemia (myocardial infarction), nearly six months, or congestive heart failure than nyha ⅱ level; hypertension (systolic blood pressure \>160 mmhg or diastolic blood pressure \>100 mmhg) that has been treated with 2 or more antihypertensive treatments and still cannot be controlled; 4. severe active clinical infection; 5. patients with coagulation disorder or bleeding constitution; 6. major surgery or severe trauma was performed within 4 weeks before enrollment; 7. a history of allogeneic organ transplantation or bone marrow transplantation; 8. drug abuse and medical, psychological or social conditions that may interfere with patients' participation in research or affect the evaluation of results; 9. known or suspected allergy to the study drug; 10. those who received treatment other than this study within 4 weeks prior to and during the study period.