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Clinical trial

A Multicenter Randomized Controlled Clinical Study of Neoadjuvant Combination of Axitinib Plus PD-1 Monoclonal Antibody to Improve Disease Free Survival of Patients With Renal Cell Carcinoma

ID
Name
2021-FXY-518
Description
The study included 246 RCC patients who were at high risk for recurrence after nephrectomy (T2G3-4 or T3-4 or N1). They were randomly divided to receive axitinib plus PD-1 + surgery or surgery alone at a ratio of 1:1, so as to determine the efficacy of the neoadjuvant combination of axitinib plus PD-1.
Trial arms
Trial start
2023-04-19
Estimated PCD
2025-07-16
Trial end
2026-03-16
Status
Recruiting
Phase
Early phase I
Treatment
Axitinib plus Toripalimab
Preoperative treatment with axitinib will be given for 3 months, 5 mg twice daily, orally. Preoperative treatment with Toripalimab will be given for 4 cycles (3 weeks considered one cycle), 240 mg, Q3W.
Arms:
Neoadjuvant group
Other names:
nephrectomy
nephrectomy
nephrectomy
Arms:
Control group, Neoadjuvant group
Size
246
Primary endpoint
disease-free survival (DFS)
2 years
Eligibility criteria
Inclusion Criteria: 1. Males or females between 18 years old and 80 years old; 2. Histopathologically confirmed clear cell carcinoma; 3. Staged as T2G3-4 or T3-T4 or N1 Exclusion Criteria: 1. With distant metastasis 2. Severe liver and renal dysfunction, combined with other serious diseases; 3. Serious cardiovascular disease, including any of the following: myocardial infarction or arteritis or venous thrombosis (such as pulmonary embolism) in the past 1 year; 4. Severe/unstable angina pectoris; uncontrolled hypertension; 5. Class III or IV heart failure by New York Heart Association (NYHA) Functional Classification; 6. Ventricular arrhythmia requiring drug treatment.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 246, 'type': 'ESTIMATED'}}
Updated at
2023-05-09

1 organization

1 product

2 indications

Organization
Zhou Fangjian
Product
Axitinib plus Toripalimab
Indication
Renal Cell Carcinoma
Indication
Neoadjuvant