Renal Cell CarcinomaPhase 3NCT05738694
Neoadjuvant of Axitinib Plus PD-1 to Improve Disease Free Survival of Patients With Renal Cell Carcinoma
A Phase 3 study testing Axitinib plus Toripalimab and nephrectomy in people with Renal Cell Carcinoma and Neoadjuvant, run by ZHOU FANGJIAN at 8 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Cell Carcinoma, Neoadjuvant
- What is being tested?
- Axitinib plus Toripalimab and nephrectomy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 298 participants
- Where
- 8 sitesChina
- Study dates
- 19 Apr 2023to 31 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily agree to participate in this study and sign the informed consent form;
- Males or females between 18 years old and 80 years old;
- Diagnosed as clear cell carcinoma or renal cell carcinoma predominantly composed of clear cell carcinoma through histopathological examination
- CT or MRI clinical staging is T2G4 or T2 with sarcomatoid differentiation, T3-4, N1;
- ECOG performance status: 0 or 1 point;
- 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.
Who cannot join
- With distant metastasis
- Severe liver and renal dysfunction, combined with other serious diseases;
- Serious cardiovascular disease, including any of the following: myocardial infarction or arteritis or venous thrombosis (such as pulmonary embolism) in the past 1 year;
- Severe/unstable angina pectoris; uncontrolled hypertension;
- Class III or IV heart failure by New York Heart Association (NYHA) Functional Classification;
- Ventricular arrhythmia requiring drug treatment.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
China8 sites, 8 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing
Sujun Han, Dr
- Recruiting
Peking University First Hospital
Beijing
Zhisong He, Dr
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou
Zhiling Zhang, Dr
- Recruiting
Anhui Provincial Hospital
Hefei
JUn Xiao, Dr
- Recruiting
Fudan University Cancer Hospital
Shanghai
Hailiang Zhang, Dr
- Recruiting
West China Hospital
Sichuan
Hao Zeng, Dr
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin
Yao Xin, Dr
- Recruiting
The First Affiliated Hospital of Zhengzhou Hospital
Zhengzhou
Xuepei Zhang, Dr
About this study
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
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.
Read the 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 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 and provide evidence-based medical evidence for clinical perioperative treatment of these patients.
- Conditions
- Renal Cell Carcinoma, Neoadjuvant
- Being tested
- Axitinib plus Toripalimab, nephrectomy
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axitinib plus ToripalimabDrug
Also called nephrectomy
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.
nephrectomyProcedure or surgery
nephrectomy
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant group | Experimental | Neoadjuvant group will be given the neoadjuvant combination of axitinib plus Toripalimab + nephrectomy Receives: Drug: Axitinib plus Toripalimab; Procedure: nephrectomy |
| Control group | Active comparator | The control group will be given nephrectomy alone. Receives: Procedure: nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease-free survival (DFS)
To evaluate the efficacy of the neoadjuvant combination of axitinib plus PD-1 in improving the 2-year disease-free survival (DFS) in RCC patients with high-risk for recurrent (T2G3-4 or T3-4, or N1). Disease-free survival (DFS) is defined as time from registration to disease progression or death.
Measured: 2 years
Secondary outcomes (5)
The cancer-specific survival (CSS)
cancer specific survival (CSS) is defined as the period between the date of randomization and the date of death from renal cancer.
Measured: 3 years
overall survival (OS)
overall survival (OS) is defined as the period between the date of randomization and the date of death from any cause
Measured: 3 years
objective response rate (ORR)
CR and PR rate as assessed by RECIST 1.1
Measured: 3 years
major pathological response (MPR)
MPR (≤10% viable malignant cells per local pathology assessment)
Measured: 3 years
adverse event management
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start19 Apr 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 298 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ZHOU FANGJIAN
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor-investigator, ZHOU FANGJIAN, Sun Yat-sen University
- Investigators
- Fangjian Zhou, Professor, Principal investigator, Director of Dept. of Urology, Sun Yat-sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05738694
- Sponsor's protocol ID
- 2021-FXY-518
- Status last verified
- Mar 2026
- First submitted
- 11 Jan 2023
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05738694
- Acronym / sponsor ID
- 2021-FXY-518
- Conditions
- Renal Cell Carcinoma, Neoadjuvant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 298 participants (estimated)
- Lead sponsor
- ZHOU FANGJIANUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 19 Apr 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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 and provide evidence-based medical evidence for clinical perioperative treatment of these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant group | Experimental | Drug: Axitinib plus Toripalimab, Procedure: nephrectomyNeoadjuvant group will be given the neoadjuvant combination of axitinib plus Toripalimab + nephrectomy |
| Control group | Active comparator | Procedure: nephrectomyThe control group will be given nephrectomy alone. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Voluntarily agree to participate in this study and sign the informed consent form;
- Males or females between 18 years old and 80 years old;
- Diagnosed as clear cell carcinoma or renal cell carcinoma predominantly composed of clear cell carcinoma through histopathological examination
- CT or MRI clinical staging is T2G4 or T2 with sarcomatoid differentiation, T3-4, N1;
- ECOG performance status: 0 or 1 point;
Key exclusion criteria (6 listed)
- With distant metastasis
- Severe liver and renal dysfunction, combined with other serious diseases;
- Serious cardiovascular disease, including any of the following: myocardial infarction or arteritis or venous thrombosis (such as pulmonary embolism) in the past 1 year;
- Severe/unstable angina pectoris; uncontrolled hypertension;
- Class III or IV heart failure by New York Heart Association (NYHA) Functional Classification;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Axitinib plus ToripalimabAlso: nephrectomyPreoperative 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. | Drug | Neoadjuvant group |
| nephrectomynephrectomy | Procedure or surgery | Control group, Neoadjuvant group |
Primary outcome
disease-free survival (DFS)
Time frame: 2 years
To evaluate the efficacy of the neoadjuvant combination of axitinib plus PD-1 in improving the 2-year disease-free survival (DFS) in RCC patients with high-risk for recurrent (T2G3-4 or T3-4, or N1). Disease-free survival (DFS) is defined as time from registration to disease progression or death.
5 secondary outcomes
The cancer-specific survival (CSS)
Time frame: 3 years
overall survival (OS)
Time frame: 3 years
objective response rate (ORR)
Time frame: 3 years
major pathological response (MPR)
Time frame: 3 years
adverse event management
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fangjian Zhou, Professor principal investigator
Director of Dept. of Urology, Sun Yat-sen University Cancer Center
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Axitinib plus Toripalimab and nephrectomy in people with Renal Cell Carcinoma and Neoadjuvant, run by ZHOU FANGJIAN at 8 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhiling Zhang, Professor (+86-020-87343860, zhangzhl@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease-free survival (DFS) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.