Overview

Toripalimab Combined With Axitinib as Neoadjuvant Therapy for Advanced/Metastatic Non-clear Cell Renal Cell Carcinoma

Status:
Not yet recruiting
Trial end date:
2022-06-01
Target enrollment:
0
Participant gender:
All
Summary
This is a single-arm phase II clinical trial to evaluate the initial efficacy and safety of toripalimab combined with axitinib as neoadjuvant therapy for advanced/metastatic non-clear cell renal cell carcinoma
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
West China Hospital
Treatments:
Axitinib
Criteria
Inclusion Criteria:

- 1) age ≥18,<75; 2) histopathological evidence of renal cell carcinoma , histological
type is non-clear cell renal cell carcinoma, and meet one of the following conditions
:(1) clinical T stage ≥2, or lymph node positive, or nuclear grading ≥3; (2) confirmed
by imaging or pathology that distant metastasis has occurred; 3) sections with
formalin-fixed paraffin blocks or at least 10 um of tissue tumor biopsy samples for
biomarker exploration studies; 4) ECOG score ≤1; 5) life expectancy above 6 months; 6)
sign informed consent, and be able to follow the visit and related procedures
stipulated in the program; 7) agree to collect tumor tissue, blood and other specimens
required by this study and apply them to relevant studies; 8)important organs and bone
marrow functions meet the following requirements: absolute neutrophil count (ANC)
≥1.5×109/L, platelet (PLT) ≥100×109/L, hemoglobin (HGB) ≥9g/dL;Liver function: serum
total bilirubin (TBIL) ≤1.5 times normal upper limit (ULN), alanine aminotransferase
(ALT) and/or aspartate aminotransferase (AST) ≤2.5 times ULN, serum albumin (ALB) ≥
2.8g /dL. Renal function: serum creatinine (Cr) ≤1.5×ULN, or creatinine clearance ≥40
mL/min; 9) cardiac function met the following conditions: baseline electrocardiogram
(ECG) had no evidence of PR prolongation or AV block;

Exclusion Criteria:

- 1) patients with other malignant tumors with different primary sites or histology from
the tumor evaluated in this study within 2 years of personal history, except those
with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or cervical
carcinoma in situ under good control; 2) major surgery or severe trauma within 4 weeks
before enrollment; 3) immunosuppressive drugs were used within 4 weeks prior to the
first dose of study therapy, excluding local glucocorticoids, inhaled or otherwise, or
systemic glucocorticoids at physiological doses (i.e., no more than 10mg/ d prednisone
or equivalent doses of other glucocorticoids); 4) known or suspected active autoimmune
diseases (congenital or acquired), such as interstitial pneumonia, uveitis, enteritis,
hepatitis, pituitary inflammation, vasculitis, nephritis, thyroiditis, etc. Patients
with type 1 diabetes with good insulin control can also be enrolled.

5) known allogeneic organ transplantation (except corneal transplantation) or
allogeneic hematopoietic stem cell transplantation; 6) allergic to any component of
monoclonal antibody; 7) suffering from other uncontrolled serious diseases, including
but not limited to: A) severe infection in the active phase or clinically poorly
controlled; B) HIV infection (HIV antibody positive); C) acute or chronic active
hepatitis b (HBsAg positive and HBV DNA>1*103/ml) or acute or chronic active hepatitis
c (HCV antibody positive and HCV RNA>15IU/ml); D) active tuberculosis, etc.; 8) class
iii-iv congestive heart failure (New York heart association classification), poorly
controlled and clinically significant arrhythmia; 9) uncontrolled arterial
hypertension (systolic blood pressure ≥160mmHg or diastolic blood pressure ≥100mmHg);
10) had any arterial thrombosis, embolism or ischemia, such as myocardial infarction,
unstable angina, cerebrovascular accident or transient ischemic attack, etc. within 6
months before the selected treatment; 11) diseases requiring the use of warfarin
(coumarin) for anticoagulant treatment; 12) uncontrolled hypercalcemia (more than 1.5
mmol/L of calcium or calcium greater than 12 mg/dL or adjusted serum calcium greater
than ULN), or symptomatic hypercalcemia requiring continued bisphosphate treatment;
13) accompanied by other malignant tumors (except those that have been cured, such as
cervical carcinoma in situ, non-melanoma skin cancer, etc.); 14) other acute or
chronic diseases, psychiatric disorders, or laboratory abnormalities that may result
in increased risk associated with study participation or study drug administration, or
interference with the interpretation of study results, and ineligibility to
participate in the study as determined by the investigator; 15) pregnant or lactating
women.