NCT05738694 Neoadjuvant of Axitinib Plus PD-1 to Improve Disease Free Survival of Patients With Renal Cell Carcinoma
| NCT ID | NCT05738694 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | ZHOU FANGJIAN |
| Condition | Renal Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 298 participants |
| Start Date | 2023-04-19 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 298 participants in total. It began in 2023-04-19 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The study included 298 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.
Eligibility Criteria
Inclusion Criteria: 1. Voluntarily agree to participate in this study and sign the informed consent form; 2. Males or females between 18 years old and 80 years old; 3. Diagnosed as clear cell carcinoma or renal cell carcinoma predominantly composed of clear cell carcinoma through histopathological examination 4. CT or MRI clinical staging is T2G4 or T2 with sarcomatoid differentiation, T3-4, N1; 5. ECOG performance status: 0 or 1 point; 6. Sufficient heart, bone marrow, liver, and kidney functions: Cardiac function: Cardiac function class 0-2; Blood routine test: WBC≥3.5×10\^9/L, absolute neutrophil count ≥1.5×10\^9/L, PLT≥75.0×10\^9/L, HGB≥80g/L; Liver function: Total bilirubin ≤1.5×upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN; Renal function: GFR ≥ 45 ml/min. 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.
Contact & Investigator
Fangjian Zhou, Professor
PRINCIPAL INVESTIGATOR
Director of Dept. of Urology, Sun Yat-sen University Cancer Center
Frequently Asked Questions
Who can join the NCT05738694 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Renal Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05738694 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 298 participants.
Is NCT05738694 currently recruiting?
Yes, NCT05738694 is actively recruiting participants. Contact the research team at zhangzhl@sysucc.org.cn for enrollment information.
Where is the NCT05738694 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China, Guangzhou, China, Hefei, China and 4 additional locations.
Who is sponsoring the NCT05738694 clinical trial?
NCT05738694 is sponsored by ZHOU FANGJIAN. The principal investigator is Fangjian Zhou, Professor at Director of Dept. of Urology, Sun Yat-sen University Cancer Center. The trial plans to enroll 298 participants.