Clinical trial NCT05738694: Neoadjuvant of Axitinib Plus PD-1 to Improve Disease Free Survival of Patients With Renal Cell Carcinoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Renal Cell Carcinoma
Neoadjuvant
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2023-02-22
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Given the good results of TKI plus PD-1 in our previous cases and its good effect on advanced RCC, we plan to eliminate tumor micrometastases and improve anti-tumor immunity with the neoadjuvant combination of axitinib plus PD-1, so as to improve patient outcomes. 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 and provide evidence-based medical evidence for clinical perioperative treatment of these patients.

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.

Primary outcomes:
measure: disease-free survival (DFS)
timeFrame: 2 years
Secondary outcomes:
measure: The cancer-specific survival (CSS)
timeFrame: 3 years
measure: overall survival (OS)
timeFrame: 3 years
measure: objective response rate (ORR)
timeFrame: 3 years
measure: major pathological response (MPR)
timeFrame: 3 years
measure: adverse event management
timeFrame: 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
city: Beijing
country: China
facility: Peking University First Hospital
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
city: Hefei
country: China
facility: Anhui Provincial Hospital
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
city: Sichuan
country: China
facility: West China Hospital
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou Hospital
Study officials:
affiliation: Director of Dept. of Urology, Sun Yat-sen University Cancer Center
name: Fangjian Zhou, Professor
role: PRINCIPAL_INVESTIGATOR
References: