Metastatic Non-Clear Cell Renal Cell CarcinomaPhase 2MANTIS-RCCNCT07816770
MANTIS-RCC: Toripalimab-Axitinib Induction in TLS-Positive Advanced Non-Clear Cell and Renal Medullary Carcinomas
A Phase 2 study testing Toripalimab, Axitinib and Deferred Cytoreductive Nephrectomy in people with Metastatic Non-Clear Cell Renal Cell Carcinoma and Metastatic Renal Medullary Carcinomas, run by Fudan University.
Trial summary
This Phase II study will evaluate toripalimab plus axitinib in adults with previously untreated, synchronous metastatic non-clear cell renal cell carcinoma and renal medullary carcinomas whose primary kidney tumor remains in place and whose baseline tumor biopsy contains a tertiary lymphoid structure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Non-Clear Cell Renal Cell Carcinoma, Metastatic Renal Medullary Carcinomas
- What is being tested?
- Toripalimab, Axitinib and Deferred Cytoreductive Nephrectomy
- 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
- 30 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2026to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older and able to provide written informed consent before any study-specific procedure.
- Newly diagnosed advanced renal cell carcinoma or renal medullary carcinoma with no prior systemic anticancer therapy for advanced disease and with the primary renal tumor still in place.
- Central pathology review of a core biopsy of the primary renal tumor confirms non-clear cell renal cell carcinoma and renal medullary carcinoma under the 2022 World Health Organization classification and finds no clear cell component. Eligible entities include papillary renal cell carcinoma, chromophobe renal cell carcinoma, TFE3-rearranged or TFEB-altered renal cell carcinoma, fumarate hydratase-deficient renal cell carcinoma, succinate dehydrogenase-deficient renal cell carcinoma, ALK-rearranged renal cell carcinoma, and renal cell carcinoma not otherwise specified or unclassified after adequate workup. Sarcomatoid or rhabdoid differentiation is recorded as a feature and is not an independent subtype.
- Clinical Stage IV disease according to the AJCC 8th edition, with synchronous distant metastasis documented by imaging or pathology.
- At least one RECIST version 1.1 measurable metastatic lesion outside the primary renal tumor: longest diameter at least 10 mm for a non-nodal lesion or short axis at least 15 mm for a lymph node.
- If deferred cytoreductive nephrectomy is anticipated, the investigator expects that at least one measurable metastatic lesion can remain for longitudinal observation; clinically necessary local treatment must not be delayed for research purposes.
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- Primary-tumor biopsy is adequate for clinical diagnosis, subtype confirmation, required immunohistochemistry or molecular testing, and central TLS assessment, and meets the protocol definition of TLS positivity.
- TLS positivity requires at least one organized lymphoid aggregate in or near viable tumor, with a recognizable CD20-positive B-cell zone adjacent to or surrounded by a CD3-positive T-cell area, and with organization exceeding scattered lymphocytes or a nonspecific small aggregate.
- Eastern Cooperative Oncology Group performance status of 0 or 1 and estimated life expectancy of at least 6 months.
- Adequate hematologic, hepatic, renal, thyroid, and coagulation function according to institutional laboratory requirements and the current prescribing information for the study drugs.
- Blood pressure is controlled with or without medication, and baseline proteinuria is acceptable for axitinib treatment in the investigator's judgment.
- Participants of reproductive potential agree to use effective contraception as required by the current prescribing information and institutional policy.
- Agreement to provide baseline tumor tissue, serial imaging, and protocol-required blood samples. Refusal of an optional early or progression biopsy or optional additional omics testing does not exclude participation.
Who cannot join
- Need for immediate surgery or local intervention for uncontrolled bleeding, infection, urinary obstruction, pain, renal failure, or another emergency that prevents safe completion of induction systemic therapy.
- Rapidly life-threatening metastatic disease requiring immediate radiotherapy, surgery, or another local treatment before study treatment.
- Active central nervous system metastases with unstable symptoms. Participants with locally treated, stable disease who are off corticosteroids or receiving a stable physiologic dose may be considered by the multidisciplinary team.
- Prior organ transplantation or active autoimmune disease requiring systemic immunosuppressive therapy. Physiologic hormone replacement or local therapy may be permitted.
- History of life-threatening immune-related toxicity from prior anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapy.
- Uncontrolled hypertension; clinically significant cardiovascular disease; recent major arterial or venous thrombosis; active bleeding; a lesion with high bleeding risk; or an uncorrectable coagulation abnormality.
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- Clinically significant proteinuria, uncontrolled thyroid dysfunction, severe hepatic or renal impairment, or another condition that makes toripalimab plus axitinib unacceptably risky.
- Active infection requiring systemic treatment. Known active hepatitis B, hepatitis C, or HIV infection is evaluated according to institutional infectious-disease policy and protocol-defined risk assessment.
- Pregnancy or breastfeeding.
- Another active malignancy within 5 years, except an adequately treated malignancy with very low recurrence risk, such as selected carcinoma in situ or basal or squamous cell skin cancer, as determined by the investigator.
- Severe hypersensitivity to either study drug or its excipients.
- Inability, in the investigator's judgment, to comply with visits, oral treatment, blood-pressure monitoring, or imaging follow-up.
- No reasonable possibility of entering the planned deferred cytoreductive nephrectomy pathway after induction, or a pathologic subtype for which the clinically preferred immediate treatment is clearly incompatible with the study intervention.
About this study
Official title: Microenvironment and Nephrectomy After Toripalimab-Axitinib Induction in TLS-Positive Advanced Non-Clear Cell Renal Carcinomas, Including SMARCB1-Deficient Renal Medullary Carcinoma: The MANTIS-RCC Phase II Study
This Phase II study will evaluate toripalimab plus axitinib in adults with previously untreated, synchronous metastatic non-clear cell renal cell carcinoma and renal medullary carcinomas whose primary kidney tumor remains in place and whose baseline tumor biopsy contains a tertiary lymphoid structure. All participants will receive toripalimab and axitinib for approximately 12 weeks. At Week 12, an independent multidisciplinary team will review treatment response, overall disease burden, fitness for surgery, technical resectability, and participant preference. Deferred cytoreductive nephrectomy will be performed only when it has an independent clinical indication; it is not mandatory and is not assigned at random. Participants who do not undergo surgery will remain in the study for clinical follow-up. The study will estimate the proportion of eligible surgical participants who remain free of progression or death 24 weeks after surgery and will evaluate whether the functional state of tertiary lymphoid structures in the treated primary tumor is associated with control of residual metastatic disease. Peripheral blood will be used to track T-cell and B-cell receptor clonotypes. Postoperative blood for this purpose will be collected only at 3 months, and disease progression.
Read the detailed description
MANTIS-RCC is an investigator-initiated, prospective, open-label, single-center, single-arm Phase II clinical and translational study. Candidate participants will undergo image-guided core biopsy of the intact primary renal tumor. Central pathology review will confirm non-clear cell renal cell carcinoma and renal medullary carcinoma, exclude any clear cell component, and confirm biopsy-detectable tertiary lymphoid structures using a prespecified morphologic and immunophenotypic definition.
Enrolled participants will receive toripalimab 240 mg by intravenous infusion every 3 weeks plus axitinib 5 mg orally twice daily for four planned cycles, corresponding to approximately 12 weeks of induction therapy. Imaging is required at baseline, Week 6, and Week 12. In the absence of progression or unacceptable toxicity, systemic therapy may continue after Week 12 and after surgery. Toripalimab may continue for up to approximately 2 years, and axitinib may continue until progression, unacceptable toxicity, withdrawal of consent, or an investigator decision that treatment should stop.
At Week 12, a multidisciplinary team that does not use the translational assay results will determine whether deferred cytoreductive nephrectomy is clinically appropriate. The decision will consider systemic disease control, performance status, operative risk, resectability of the primary tumor, metastatic burden, the clinical purpose of surgery, and participant preference. Surgery will not be performed solely to obtain research tissue. Participants with rapid progression, organ-threatening disease, unacceptable surgical risk, or a need to change systemic therapy will not undergo elective cytoreductive nephrectomy but will remain in the intention-to-treat clinical cohort.
The main postoperative analysis population will include participants who undergo protocol-defined deferred cytoreductive nephrectomy, have at least one measurable metastatic lesion that is not removed or locally treated at surgery, and are expected to resume the same systemic regimen. The surgery date is the landmark for postoperative time-to-event outcomes. Imaging obtained within 14 days before surgery provides the reference metastatic burden; imaging at 4 to 6 weeks after surgery confirms postoperative status but does not restart the progression-free survival clock.
The translational program integrates treated primary-tumor tissue, longitudinal imaging, and immune-repertoire measurements. The postoperative primary tumor will be used to construct a patient-level TLS Functional State Score. TCR sequencing is the primary repertoire analysis and BCR sequencing is supportive. Peripheral blood collected before surgery may include baseline, Week 3, Week 6, Week 12, and the day of surgery. After surgery, peripheral blood for TCR/BCR analysis will be collected only at Month 3, Month 6, and disease progression. The progression sample should be collected before a new systemic or local treatment when clinically feasible. The Month 3 samples will be used to characterize persistence of prespecified TLS-associated clonotypes; the progression sample will characterize loss, re-expansion, and newly detectable clonotypes.
The study is estimation-oriented. Thirty participants are planned. Enrollment may expand to a maximum of 40 only if an independent review confirms acceptable safety and feasibility and fewer than 20 participants are available for the postoperative residual-metastasis primary analysis, with ethics approval before expansion. The study does not test whether cytoreductive nephrectomy improves survival and does not include a TLS-negative comparison group or a randomized no-surgery control.
- Being tested
- Toripalimab, Axitinib, Deferred Cytoreductive Nephrectomy
- Keywords
- Non-clear cell renal cell carcinoma, metastatic renal cell carcinoma, tertiary lymphoid structures, toripalimab, axitinib, deferred cytoreductive nephrectomy, Metastatic Renal Medullary Carcinomas
- Medical subject headings
- Carcinoma, Renal Cell, Tertiary Lymphoid Structures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToripalimabDrug
Toripalimab 240 mg is administered by intravenous infusion on Day 1 of each 3-week cycle for four planned induction cycles. Dose reduction is not permitted. In participants without progression or unacceptable toxicity, treatment may resume or continue after Week 12 and after surgery for a total duration of up to approximately 2 years, according to the protocol and clinical judgment.
AxitinibDrug
Axitinib 5 mg is administered orally twice daily continuously during induction. Dose interruption and reduction to 3 mg twice daily and then 2 mg twice daily are permitted for toxicity. The drug is withheld before elective surgery and restarted after adequate wound healing. It may continue until progression, unacceptable toxicity, withdrawal, or investigator decision.
Deferred Cytoreductive NephrectomyProcedure or surgery
After Week 12 multidisciplinary review, radical or partial nephrectomy may be performed when clinically indicated and technically appropriate. The surgical approach is selected by the treating surgical team. The procedure is not mandatory, is not randomized, and is never performed solely to obtain research tissue.
| Study group | Role | What they receive |
|---|---|---|
| Toripalimab Plus Axitinib With Selective Deferred Cytoreductive Nephrectomy | Experimental | Participants receive toripalimab plus axitinib for approximately 12 weeks. At Week 12, an independent multidisciplinary team determines whether deferred cytoreductive nephrectomy is clinically appropriate. Surgery is performed only for participants with clinical benefit, controlled systemic disease, acceptable operative risk, a safely resectable primary tumor, and an independent clinical indication. Participants who do not undergo surgery continue clinically appropriate systemic therapy and study follow-up. Receives: Drug: Toripalimab; Drug: Axitinib; Procedure: Deferred Cytoreductive Nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-Week Progression-Free Survival Rate From Deferred Cytoreductive Nephrectomy
Percentage of participants in the postoperative residual-metastasis primary analysis population who are alive and have not had central RECIST version 1.1 progression by 24 weeks after surgery. Starting a new systemic treatment or receiving local treatment for progression or symptoms in a residual metastatic lesion is counted as an event in the primary strategy.
Measured: From the date of deferred cytoreductive nephrectomy through 24 weeks after surgery
Association Between the TLS Functional State Score and 24-Week Postoperative Progression-Free Survival
The patient-level TLS Functional State Score is derived from the treated primary renal tumor removed at surgery using prespecified pathology and multiplex immunofluorescence features. Association with 24-week postoperative progression-free survival is summarized as the odds ratio per 1-standard-deviation increase in the score, with a 95% confidence interval.
Measured: Tumor tissue collected at surgery; clinical outcome assessed through 24 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start20 Sep 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- 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 Metastatic Non-Clear Cell Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Model description
- All enrolled participants receive toripalimab plus axitinib. After approximately 12 weeks, an independent multidisciplinary team determines whether deferred cytoreductive nephrectomy is clinically indicated. The surgical and nonsurgical pathways are not randomized treatment arms; all participants remain in the same intention-to-treat cohort. The protocol plans 30 participants and permits expansion to a maximum of 40 only after prespecified independent safety and feasibility review and ethics approval.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ding-Wei Ye, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07816770
- Sponsor's protocol ID
- MANTIS-RCC-001
- Acronym
- MANTIS-RCC
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microenvironment and Nephrectomy After Toripalimab-Axitinib Induction in TLS-Positive Advanced Non-Clear Cell Renal Carcinomas, Including SMARCB1-Deficient Renal Medullary Carcinoma: The MANTIS-RCC Phase II Study
- ClinicalTrials.gov ID
- NCT07816770
- Acronym / sponsor ID
- MANTIS-RCC / MANTIS-RCC-001
- Keywords
- Non-clear cell renal cell carcinoma, metastatic renal cell carcinoma, tertiary lymphoid structures, toripalimab, axitinib, deferred cytoreductive nephrectomy, Metastatic Renal Medullary Carcinomas
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 20 Sep 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 14 Sep 2026 (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.
This Phase II study will evaluate toripalimab plus axitinib in adults with previously untreated, synchronous metastatic non-clear cell renal cell carcinoma and renal medullary carcinomas whose primary kidney tumor remains in place and whose baseline tumor biopsy contains a tertiary lymphoid structure. All participants will receive toripalimab and axitinib for approximately 12 weeks. At Week 12, an independent multidisciplinary team will review treatment response, overall disease burden, fitness for surgery, technical resectability, and participant preference. Deferred cytoreductive nephrectomy will be performed only when it has an independent clinical indication; it is not mandatory and is not assigned at random. Participants who do not undergo surgery will remain in the study for clinical follow-up. The study will estimate the proportion of eligible surgical participants who remain free of progression or death 24 weeks after surgery and will evaluate whether the functional state of tertiary lymphoid structures in the treated primary tumor is associated with control of residual metastatic disease. Peripheral blood will be used to track T-cell and B-cell receptor clonotypes. Postoperative blood for this purpose will be collected only at 3 months, and disease progression.
Detailed description
MANTIS-RCC is an investigator-initiated, prospective, open-label, single-center, single-arm Phase II clinical and translational study. Candidate participants will undergo image-guided core biopsy of the intact primary renal tumor. Central pathology review will confirm non-clear cell renal cell carcinoma and renal medullary carcinoma, exclude any clear cell component, and confirm biopsy-detectable tertiary lymphoid structures using a prespecified morphologic and immunophenotypic definition.
Enrolled participants will receive toripalimab 240 mg by intravenous infusion every 3 weeks plus axitinib 5 mg orally twice daily for four planned cycles, corresponding to approximately 12 weeks of induction therapy. Imaging is required at baseline, Week 6, and Week 12. In the absence of progression or unacceptable toxicity, systemic therapy may continue after Week 12 and after surgery. Toripalimab may continue for up to approximately 2 years, and axitinib may continue until progression, unacceptable toxicity, withdrawal of consent, or an investigator decision that treatment should stop.
At Week 12, a multidisciplinary team that does not use the translational assay results will determine whether deferred cytoreductive nephrectomy is clinically appropriate. The decision will consider systemic disease control, performance status, operative risk, resectability of the primary tumor, metastatic burden, the clinical purpose of surgery, and participant preference. Surgery will not be performed solely to obtain research tissue. Participants with rapid progression, organ-threatening disease, unacceptable surgical risk, or a need to change systemic therapy will not undergo elective cytoreductive nephrectomy but will remain in the intention-to-treat clinical cohort.
The main postoperative analysis population will include participants who undergo protocol-defined deferred cytoreductive nephrectomy, have at least one measurable metastatic lesion that is not removed or locally treated at surgery, and are expected to resume the same systemic regimen. The surgery date is the landmark for postoperative time-to-event outcomes. Imaging obtained within 14 days before surgery provides the reference metastatic burden; imaging at 4 to 6 weeks after surgery confirms postoperative status but does not restart the progression-free survival clock.
The translational program integrates treated primary-tumor tissue, longitudinal imaging, and immune-repertoire measurements. The postoperative primary tumor will be used to construct a patient-level TLS Functional State Score. TCR sequencing is the primary repertoire analysis and BCR sequencing is supportive. Peripheral blood collected before surgery may include baseline, Week 3, Week 6, Week 12, and the day of surgery. After surgery, peripheral blood for TCR/BCR analysis will be collected only at Month 3, Month 6, and disease progression. The progression sample should be collected before a new systemic or local treatment when clinically feasible. The Month 3 samples will be used to characterize persistence of prespecified TLS-associated clonotypes; the progression sample will characterize loss, re-expansion, and newly detectable clonotypes.
The study is estimation-oriented. Thirty participants are planned. Enrollment may expand to a maximum of 40 only if an independent review confirms acceptable safety and feasibility and fewer than 20 participants are available for the postoperative residual-metastasis primary analysis, with ethics approval before expansion. The study does not test whether cytoreductive nephrectomy improves survival and does not include a TLS-negative comparison group or a randomized no-surgery control.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled participants receive toripalimab plus axitinib. After approximately 12 weeks, an independent multidisciplinary team determines whether deferred cytoreductive nephrectomy is clinically indicated. The surgical and nonsurgical pathways are not randomized treatment arms; all participants remain in the same intention-to-treat cohort. The protocol plans 30 participants and permits expansion to a maximum of 40 only after prespecified independent safety and feasibility review and ethics approval.
| Arm | Type | Receives |
|---|---|---|
| Toripalimab Plus Axitinib With Selective Deferred Cytoreductive Nephrectomy | Experimental | Drug: Toripalimab, Drug: Axitinib, Procedure: Deferred Cytoreductive NephrectomyParticipants receive toripalimab plus axitinib for approximately 12 weeks. At Week 12, an independent multidisciplinary team determines whether deferred cytoreductive nephrectomy is clinically appropriate. Surgery is performed only for participants with clinical benefit, controlled systemic disease, acceptable operative risk, a safely resectable primary tumor, and an independent clinical indication. Participants who do not undergo surgery continue clinically appropriate systemic therapy and study follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age 18 years or older and able to provide written informed consent before any study-specific procedure.
- Newly diagnosed advanced renal cell carcinoma or renal medullary carcinoma with no prior systemic anticancer therapy for advanced disease and with the primary renal tumor still in place.
- Central pathology review of a core biopsy of the primary renal tumor confirms non-clear cell renal cell carcinoma and renal medullary carcinoma under the 2022 World Health Organization classification and finds no clear cell component. Eligible entities include papillary renal cell carcinoma, chromophobe renal cell carcinoma, TFE3-rearranged or TFEB-altered renal cell carcinoma, fumarate hydratase-deficient renal cell carcinoma, succinate dehydrogenase-deficient renal cell carcinoma, ALK-rearranged renal cell carcinoma, and renal cell carcinoma not otherwise specified or unclassified after adequate workup. Sarcomatoid or rhabdoid differentiation is recorded as a feature and is not an independent subtype.
- Clinical Stage IV disease according to the AJCC 8th edition, with synchronous distant metastasis documented by imaging or pathology.
- At least one RECIST version 1.1 measurable metastatic lesion outside the primary renal tumor: longest diameter at least 10 mm for a non-nodal lesion or short axis at least 15 mm for a lymph node.
Key exclusion criteria (13 listed)
- Need for immediate surgery or local intervention for uncontrolled bleeding, infection, urinary obstruction, pain, renal failure, or another emergency that prevents safe completion of induction systemic therapy.
- Rapidly life-threatening metastatic disease requiring immediate radiotherapy, surgery, or another local treatment before study treatment.
- Active central nervous system metastases with unstable symptoms. Participants with locally treated, stable disease who are off corticosteroids or receiving a stable physiologic dose may be considered by the multidisciplinary team.
- Prior organ transplantation or active autoimmune disease requiring systemic immunosuppressive therapy. Physiologic hormone replacement or local therapy may be permitted.
- History of life-threatening immune-related toxicity from prior anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapy.
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 |
|---|---|---|
| ToripalimabToripalimab 240 mg is administered by intravenous infusion on Day 1 of each 3-week cycle for four planned induction cycles. Dose reduction is not permitted. In participants without progression or unacceptable toxicity, treatment may resume or continue after Week 12 and after surgery for a total duration of up to approximately 2 years, according to the protocol and clinical judgment. | Drug | Toripalimab Plus Axitinib With Selective Deferred Cytoreductive Nephrectomy |
| AxitinibAxitinib 5 mg is administered orally twice daily continuously during induction. Dose interruption and reduction to 3 mg twice daily and then 2 mg twice daily are permitted for toxicity. The drug is withheld before elective surgery and restarted after adequate wound healing. It may continue until progression, unacceptable toxicity, withdrawal, or investigator decision. | Drug | Toripalimab Plus Axitinib With Selective Deferred Cytoreductive Nephrectomy |
| Deferred Cytoreductive NephrectomyAfter Week 12 multidisciplinary review, radical or partial nephrectomy may be performed when clinically indicated and technically appropriate. The surgical approach is selected by the treating surgical team. The procedure is not mandatory, is not randomized, and is never performed solely to obtain research tissue. | Procedure or surgery | Toripalimab Plus Axitinib With Selective Deferred Cytoreductive Nephrectomy |
Primary outcome
24-Week Progression-Free Survival Rate From Deferred Cytoreductive Nephrectomy
Time frame: From the date of deferred cytoreductive nephrectomy through 24 weeks after surgery
Percentage of participants in the postoperative residual-metastasis primary analysis population who are alive and have not had central RECIST version 1.1 progression by 24 weeks after surgery. Starting a new systemic treatment or receiving local treatment for progression or symptoms in a residual metastatic lesion is counted as an event in the primary strategy.
Association Between the TLS Functional State Score and 24-Week Postoperative Progression-Free Survival
Time frame: Tumor tissue collected at surgery; clinical outcome assessed through 24 weeks after surgery
The patient-level TLS Functional State Score is derived from the treated primary renal tumor removed at surgery using prespecified pathology and multiplex immunofluorescence features. Association with 24-week postoperative progression-free survival is summarized as the odds ratio per 1-standard-deviation increase in the score, with a 95% confidence interval.
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 14 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Toripalimab, Axitinib and Deferred Cytoreductive Nephrectomy in people with Metastatic Non-Clear Cell Renal Cell Carcinoma and Metastatic Renal Medullary Carcinomas, run by Fudan University.
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 13 inclusion and 13 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: opening soon, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
24-Week Progression-Free Survival Rate From Deferred Cytoreductive Nephrectomy (time frame: From the date of deferred cytoreductive nephrectomy through 24 weeks after surgery). The study lists 2 primary outcomes in all. 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 14 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.