A Study of AK104 Plus Axitinib in Advanced/Metastatic Special Pathological Subtypes of Renal Cell Carcinoma

Launched by HAO ZENG · Apr 10, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment combination for patients with advanced types of kidney cancer known as renal cell carcinoma (RCC). Specifically, it is looking at the effectiveness and safety of two medications, AK104 and axitinib, when used together as the first treatment option for patients with certain special subtypes of RCC. Participants in the trial will receive these medications until their disease progresses, they experience unacceptable side effects, or they decide to leave the study. The main goals are to see how well the treatment works and how long patients can live without their cancer worsening.

To join this trial, participants need to be between 18 and 75 years old and have a specific type of metastatic renal cell carcinoma that has not been treated before. They should also be in relatively good health, without severe heart or infection issues, and have a life expectancy of at least three months. Throughout the trial, patients will be monitored closely by healthcare professionals. This study is currently recruiting new participants, so if you or someone you know is interested, it could be an opportunity to access a new treatment.

Gender

ALL

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.