Neoadjuvant of Axitinib Plus PD-1 to Improve Disease Free Survival of Patients With Renal Cell Carcinoma

• Status: Not yet recruiting
• Trial end date: 2026-03-16
• Target enrollment: 0
• Participant gender: All

Summary

The study included 110 RCC patients who were at high risk for recurrence after nephrectomy (T2G3-4 or T3-4 or N1) or oligometastasis who were scheduled to receive radical topical therapy (M1 NEG). 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ZHOU FANGJIAN
• Collaborator: Pfizer
• Treatments: Axitinib

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 or M1 NEG (less than 5 metastases, planned to receive radical Treatment of metastases within 12 weeks after surgery).

Exclusion Criteria:

1. Brain, liver or bone metastases;

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.