Immune Checkpoint InhibitorsPhase 2NCT06279403
Upfront Immune Checkpoint Inhibitors With Deferred Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma
A Phase 2 study testing Toripalimab, Cytoreductive Nephrectomy and Axitinib in people with Immune Checkpoint Inhibitors and Cytoreductive Nephrectomy, run by RenJi Hospital at 1 site in China.
Trial summary
Study Objective: To determine the efficacy of upfront immune checkpoint inhibitors combined with deferred cytoreductive nephrectomy in treating metastatic renal cell carcinoma. Primary Endpoint: Pathological Major Response (MPR), defined as the percentage of residual tumor ≦10% in the primary tumor after nephrectomy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Immune Checkpoint Inhibitors, Cytoreductive Nephrectomy, Clear Cell Renal Cell Cancer (ccRCC)
- What is being tested?
- Toripalimab, Cytoreductive Nephrectomy and Axitinib
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 30 Jun 2028
- Phase
- Phase 2
- 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
- Willingness to participate in the study and provision of written informed consent.
- Male or female participants aged ≥18 years and <80 years. Histologically confirmed clear cell renal cell carcinoma or renal cell carcinoma with a predominant clear cell component.
- Clinical staging by CT or MRI demonstrating either any T, N1, M0 disease or any T, any N, M1 disease, together with at least one of the following: an IMDC score ≤3; or ≤5 metastatic lesions involving ≤3 organs.
- A primary renal tumor, whether unilateral or bilateral, considered resectable. ECOG performance status of 0 or 1. No clinically significant abnormalities in cardiac, bone marrow, hepatic, or renal function.
- Willingness and ability to comply with study assessments and follow-up procedures.
Who cannot join
- Non-clear cell carcinoma. Severe liver or kidney dysfunction, or other severe diseases. Immune deficiency, organ transplantation, or autoimmune diseases. Severe central nervous system diseases. Other malignant tumors within the past 5 years, except for cured basal cell carcinoma of the skin and cervical carcinoma in situ.
- Unable to comply with regular follow-up visits due to psychological, social, family, or geographical reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Upfront Toripalimab Plus Axitinib Combined With Deferred Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma
Study Objective: To determine the efficacy of upfront immune checkpoint inhibitors combined with deferred cytoreductive nephrectomy in treating metastatic renal cell carcinoma.
Primary Endpoint: Pathological Major Response (MPR), defined as the percentage of residual tumor ≦10% in the primary tumor after nephrectomy.
Read more
Study Design:
Population: Participants meeting the diagnostic criteria with biopsy-proven clear cell renal cell carcinoma. Clinical staging by CT or MRI demonstrating either any T, N1, M0 disease or any T, any N, M1 disease, together with at least one of the following: an IMDC score ≤3; or ≤5 metastatic lesions involving ≤3 organs.
Patient Grouping: Non-randomized.
Interventions: Eligible participants will receive upfront treatment with a combination of Axitinib and Toripalimab for 4 cycles. After 2 cycles of treatment, radiological assessment will be conducted using RECIST 1.1 criteria. If disease progression is observed, the clinical trial will be terminated, and second-line treatment will be initiated according to guidelines. If disease progression is not observed, treatment will continue for 2 additional cycles followed by repeat radiological assessment before undergoing surgery.
- Conditions
- Immune Checkpoint Inhibitors, Cytoreductive Nephrectomy, Clear Cell Renal Cell Cancer (ccRCC)
- Being tested
- Toripalimab, Cytoreductive Nephrectomy, Axitinib
- 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.
ToripalimabDrug
Preoperative Treatment with Toripalimab: Administer 240mg of Toripalimab via intravenous infusion every 3 weeks for a total of 4 cycles.
Cytoreductive NephrectomyProcedure or surgery
Radical Nephrectomy: Complete resection of the tumor and affected kidney within the renal fascia.
Partial Nephrectomy: Complete resection of the tumor while preserving maximal kidney function.
Lymph Node Dissection: For patients with evident enlargement of retroperitoneal lymph nodes preoperatively, perform lymph node dissection at the renal hilum, along the ipsilateral major vessels, and anterior to the ipsilateral major vessels. Lymph node dissection is not required for patients without evident enlargement of retroperitoneal lymph nodes preoperatively.
AxitinibDrug
Preoperative Treatment with Axitinib: Administer 5mg of axitinib orally twice daily for a duration of 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Experimental arm Receives: Drug: Toripalimab; Procedure: Cytoreductive Nephrectomy; Drug: Axitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Major Response (MPR)
The percentage of residual tumor in the primary tumor after surgery, with MPR defined as ≦10% of residual tumor.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Mar 2024
- Primary completion30 Jun 2026
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune Checkpoint InhibitorsStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06279403
- Sponsor's protocol ID
- IIT-2023-0277
- Status last verified
- Oct 2026
- First submitted
- 29 Jan 2024
- Last updated
- 27 Oct 2026
- Results posted
- No
- 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 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upfront Toripalimab Plus Axitinib Combined With Deferred Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06279403
- Acronym / sponsor ID
- IIT-2023-0277
- Conditions
- Immune Checkpoint Inhibitors, Cytoreductive Nephrectomy, Clear Cell Renal Cell Cancer (ccRCC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 21 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 28 Feb 2024 (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.
Study Objective: To determine the efficacy of upfront immune checkpoint inhibitors combined with deferred cytoreductive nephrectomy in treating metastatic renal cell carcinoma.
Primary Endpoint: Pathological Major Response (MPR), defined as the percentage of residual tumor ≦10% in the primary tumor after nephrectomy.
Study Design:
Population: Participants meeting the diagnostic criteria with biopsy-proven clear cell renal cell carcinoma. Clinical staging by CT or MRI demonstrating either any T, N1, M0 disease or any T, any N, M1 disease, together with at least one of the following: an IMDC score ≤3; or ≤5 metastatic lesions involving ≤3 organs.
Patient Grouping: Non-randomized.
Interventions: Eligible participants will receive upfront treatment with a combination of Axitinib and Toripalimab for 4 cycles. After 2 cycles of treatment, radiological assessment will be conducted using RECIST 1.1 criteria. If disease progression is observed, the clinical trial will be terminated, and second-line treatment will be initiated according to guidelines. If disease progression is not observed, treatment will continue for 2 additional cycles followed by repeat radiological assessment before undergoing surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Toripalimab, Procedure: Cytoreductive Nephrectomy, Drug: AxitinibExperimental arm |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Willingness to participate in the study and provision of written informed consent.
- Male or female participants aged ≥18 years and <80 years. Histologically confirmed clear cell renal cell carcinoma or renal cell carcinoma with a predominant clear cell component.
- Clinical staging by CT or MRI demonstrating either any T, N1, M0 disease or any T, any N, M1 disease, together with at least one of the following: an IMDC score ≤3; or ≤5 metastatic lesions involving ≤3 organs.
- A primary renal tumor, whether unilateral or bilateral, considered resectable. ECOG performance status of 0 or 1. No clinically significant abnormalities in cardiac, bone marrow, hepatic, or renal function.
- Willingness and ability to comply with study assessments and follow-up procedures.
Key exclusion criteria (2 listed)
- Non-clear cell carcinoma. Severe liver or kidney dysfunction, or other severe diseases. Immune deficiency, organ transplantation, or autoimmune diseases. Severe central nervous system diseases. Other malignant tumors within the past 5 years, except for cured basal cell carcinoma of the skin and cervical carcinoma in situ.
- Unable to comply with regular follow-up visits due to psychological, social, family, or geographical reasons.
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 |
|---|---|---|
| ToripalimabPreoperative Treatment with Toripalimab: Administer 240mg of Toripalimab via intravenous infusion every 3 weeks for a total of 4 cycles. | Drug | Experimental |
| Cytoreductive NephrectomyRadical Nephrectomy: Complete resection of the tumor and affected kidney within the renal fascia. Partial Nephrectomy: Complete resection of the tumor while preserving maximal kidney function. Lymph Node Dissection: For patients with evident enlargement of retroperitoneal lymph nodes preoperatively, perform lymph node dissection at the renal hilum, along the ipsilateral major vessels, and anterior to the ipsilateral major vessels. Lymph node dissection is not required for patients without evident enlargement of retroperitoneal lymph nodes preoperatively. | Procedure or surgery | Experimental |
| AxitinibPreoperative Treatment with Axitinib: Administer 5mg of axitinib orally twice daily for a duration of 3 months. | Drug | Experimental |
Primary outcome
Pathological Major Response (MPR)
Time frame: through study completion, an average of 1 year
The percentage of residual tumor in the primary tumor after surgery, with MPR defined as ≦10% of residual tumor.
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 27 Oct 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Toripalimab, Cytoreductive Nephrectomy and Axitinib in people with Immune Checkpoint Inhibitors and Cytoreductive Nephrectomy, run by RenJi Hospital at 1 site 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 5 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Major Response (MPR) (time frame: through study completion, an average of 1 year). 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 27 Oct 2026.