Non-Clear Cell Renal Cell CarcinomaPhase 2NCT07488533
Comparing the Combination of Sullumab and Fruquintinib in Postoperative Adjuvant Therapy for High Recurrence Risk Non Transparent Renal Cell Carcinoma
A Phase 2 study testing Serplulimab in combination with Fruquintinib in people with Non-Clear Cell Renal Cell Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
This study is testing a new treatment approach for people who have had surgery to remove a type of kidney cancer called non-clear cell renal cell carcinoma (non-ccRCC). This kind of kidney cancer is different from the most common type and tends to come back after surgery, especially in high-risk patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Clear Cell Renal Cell Carcinoma
- What is being tested?
- Serplulimab in combination with Fruquintinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to 31 Dec 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years, inclusive.
- Histologically confirmed diagnosis of non-clear cell renal cell carcinoma (non-ccRCC), including papillary, chromophobe, collecting duct, or other non-clear cell subtypes.
- Completed radical nephrectomy (open or laparoscopic) with no evidence of residual tumor by imaging or pathology.
- High-risk features defined as one or more of the following: pT3 or higher, regional lymph node involvement (N1), sarcomatoid differentiation, tumor necrosis, Fuhrman/ISUP nuclear grade ≥3, or positive surgical margin.
- ECOG performance status of 0 or 1.
- Adequate organ function: neutrophils ≥1.5 × 10⁹/L, platelets ≥100 × 10⁹/L, hemoglobin ≥9 g/dL; total bilirubin ≤1.5 × ULN; ALT/AST ≤2.5 × ULN; creatinine clearance ≥50 mL/min; INR ≤1.5.
- No prior adjuvant or neoadjuvant systemic anti-tumor therapy.
- Willing and able to provide written informed consent and comply with study procedures.
Who cannot join
- Pathological diagnosis of clear cell renal cell carcinoma or mixed histology with ≥20% clear cell component.
- Evidence of distant metastasis (M1) at baseline.
- History of active autoimmune disease (e.g., lupus, rheumatoid arthritis, inflammatory bowel disease) or current use of immunosuppressive agents.
- Uncontrolled hypertension (systolic >150 mmHg or diastolic >100 mmHg), significant cardiovascular disease, or uncontrolled heart failure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled, Multicenter Phase III Clinical Study Comparing the Combination of Sullimumab and Fruquintinib in Postoperative Adjuvant Therapy for High Recurrence Risk Non Transparent Renal Cell Carcinoma
This study is testing a new treatment approach for people who have had surgery to remove a type of kidney cancer called non-clear cell renal cell carcinoma (non-ccRCC). This kind of kidney cancer is different from the most common type and tends to come back after surgery, especially in high-risk patients.
After surgery, many patients are at risk of their cancer returning. Right now, there is no standard treatment to prevent this from happening. This study aims to find out if combining two medications-Serplulimab (a PD-1 inhibitor) and Fruquintinib (a targeted drug that blocks blood vessel growth in tumors)-can help reduce the chance of cancer coming back.
Read more
The study will include up to 40 adults aged 18 to 75 who have had surgery to remove the tumor and are at high risk of recurrence. All participants will receive both drugs as part of an adjuvant therapy, meaning it is given after surgery to lower the risk of cancer returning.
Serplulimab will be given by IV every three weeks. Fruquintinib will be taken orally daily, with a schedule of 3 weeks on and 1 week off.
Treatment will last up to 12 months. Participants will be closely monitored throughout the study with regular check-ups, blood tests, imaging scans (like CT or MRI), and safety assessments. The main goal is to see how long patients stay free of cancer (called "disease-free survival"). Other goals include checking how well the treatment works, how safe it is, and whether certain biomarkers (like PD-L1 levels or genetic changes in tumor DNA) can predict who benefits most.
All medical care related to the study-including visits, scans, lab tests, and the study drugs-will be provided at no cost to participants. Participants may also have access to advanced molecular testing through a partner laboratory.
This is a single-center, open-label study, meaning everyone involved knows which treatment is being used. There is no placebo group; all participants receive active treatment.
The study team believes this combination could offer a promising way to improve outcomes for people with high-risk non-ccRCC after surgery. If successful, it may lead to a new standard of care for this patient group.
Participation is voluntary. Patients can leave the study at any time without affecting future medical care. Risks include side effects from the drugs, such as fatigue, high blood pressure, diarrhea, or immune-related reactions. The research team will monitor these carefully and provide appropriate care.
This study is being conducted by researchers at a single hospital in China and supported by domestic pharmaceutical companies. It follows all national and international guidelines for ethical research involving human participants.
It is hoped that this study will help better understand how to prevent kidney cancer from returning and improve survival for patients.
- Conditions
- Non-Clear Cell Renal Cell Carcinoma
- Being tested
- Serplulimab in combination with Fruquintinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serplulimab in combination with FruquintinibDrug
Also called Serplulimab + Fruquintinib
This intervention consists of a combination of Serplulimab, a humanized anti-PD-1 monoclonal antibody, and Fruquintinib, a selective oral inhibitor of vascular endothelial growth factor receptors (VEGFRs). Serplulimab is administered intravenously at 3 mg/kg every 3 weeks. Fruquintinib is taken orally at 5 mg daily on a 3-week-on/1-week-off schedule. The regimen is given for up to 12 months following radical nephrectomy as adjuvant therapy in patients with high-risk non-clear cell renal cell carcinoma. The dual mechanism aims to enhance anti-tumor immunity by blocking immune checkpoint inhibition while simultaneously inhibiting tumor angiogenesis.
| Study group | Role | What they receive |
|---|---|---|
| Serplulimab + Fruquintinib Adjuvant Therapy | Experimental | Participants in this arm will receive adjuvant therapy with Serplulimab (3 mg/kg IV every 3 weeks) and Fruquintinib (5 mg orally daily, administered on a 3-week-on/1-week-off schedule) for up to 12 months following radical nephrectomy. The treatment aims to reduce the risk of cancer recurrence in high-risk non-clear cell renal cell carcinoma patients. Safety monitoring, imaging assessments, and biomarker analyses will be conducted throughout the study period. Receives: Drug: Serplulimab in combination with Fruquintinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
OS will be estimated using the Kaplan-Meier method and compared with historical controls.
Measured: From the date of radical nephrectomy until death from any cause, assessed up to 60 months.
Secondary outcomes (1)
DFS
Disease-Free Survival
Measured: From randomization until disease recurrence or death, assessed up to 60 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start1 Aug 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Clear Cell Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZHOU FANGJIAN, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07488533
- Sponsor's protocol ID
- 2025-FXY-300
- Status last verified
- Mar 2026
- First submitted
- 19 Jan 2026
- Last updated
- 23 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 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled, Multicenter Phase III Clinical Study Comparing the Combination of Sullimumab and Fruquintinib in Postoperative Adjuvant Therapy for High Recurrence Risk Non Transparent Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07488533
- Acronym / sponsor ID
- 2025-FXY-300
- Conditions
- Non-Clear Cell Renal Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 23 Mar 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 study is testing a new treatment approach for people who have had surgery to remove a type of kidney cancer called non-clear cell renal cell carcinoma (non-ccRCC). This kind of kidney cancer is different from the most common type and tends to come back after surgery, especially in high-risk patients.
After surgery, many patients are at risk of their cancer returning. Right now, there is no standard treatment to prevent this from happening. This study aims to find out if combining two medications-Serplulimab (a PD-1 inhibitor) and Fruquintinib (a targeted drug that blocks blood vessel growth in tumors)-can help reduce the chance of cancer coming back.
The study will include up to 40 adults aged 18 to 75 who have had surgery to remove the tumor and are at high risk of recurrence. All participants will receive both drugs as part of an adjuvant therapy, meaning it is given after surgery to lower the risk of cancer returning.
Serplulimab will be given by IV every three weeks. Fruquintinib will be taken orally daily, with a schedule of 3 weeks on and 1 week off.
Treatment will last up to 12 months. Participants will be closely monitored throughout the study with regular check-ups, blood tests, imaging scans (like CT or MRI), and safety assessments. The main goal is to see how long patients stay free of cancer (called "disease-free survival"). Other goals include checking how well the treatment works, how safe it is, and whether certain biomarkers (like PD-L1 levels or genetic changes in tumor DNA) can predict who benefits most.
All medical care related to the study-including visits, scans, lab tests, and the study drugs-will be provided at no cost to participants. Participants may also have access to advanced molecular testing through a partner laboratory.
This is a single-center, open-label study, meaning everyone involved knows which treatment is being used. There is no placebo group; all participants receive active treatment.
The study team believes this combination could offer a promising way to improve outcomes for people with high-risk non-ccRCC after surgery. If successful, it may lead to a new standard of care for this patient group.
Participation is voluntary. Patients can leave the study at any time without affecting future medical care. Risks include side effects from the drugs, such as fatigue, high blood pressure, diarrhea, or immune-related reactions. The research team will monitor these carefully and provide appropriate care.
This study is being conducted by researchers at a single hospital in China and supported by domestic pharmaceutical companies. It follows all national and international guidelines for ethical research involving human participants.
It is hoped that this study will help better understand how to prevent kidney cancer from returning and improve survival for patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Serplulimab + Fruquintinib Adjuvant Therapy | Experimental | Drug: Serplulimab in combination with FruquintinibParticipants in this arm will receive adjuvant therapy with Serplulimab (3 mg/kg IV every 3 weeks) and Fruquintinib (5 mg orally daily, administered on a 3-week-on/1-week-off schedule) for up to 12 months following radical nephrectomy. The treatment aims to reduce the risk of cancer recurrence in high-risk non-clear cell renal cell carcinoma patients. Safety monitoring, imaging assessments, and biomarker analyses will be conducted throughout the study period. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age between 18 and 75 years, inclusive.
- Histologically confirmed diagnosis of non-clear cell renal cell carcinoma (non-ccRCC), including papillary, chromophobe, collecting duct, or other non-clear cell subtypes.
- Completed radical nephrectomy (open or laparoscopic) with no evidence of residual tumor by imaging or pathology.
- High-risk features defined as one or more of the following: pT3 or higher, regional lymph node involvement (N1), sarcomatoid differentiation, tumor necrosis, Fuhrman/ISUP nuclear grade ≥3, or positive surgical margin.
- ECOG performance status of 0 or 1.
Key exclusion criteria (4 listed)
- Pathological diagnosis of clear cell renal cell carcinoma or mixed histology with ≥20% clear cell component.
- Evidence of distant metastasis (M1) at baseline.
- History of active autoimmune disease (e.g., lupus, rheumatoid arthritis, inflammatory bowel disease) or current use of immunosuppressive agents.
- Uncontrolled hypertension (systolic >150 mmHg or diastolic >100 mmHg), significant cardiovascular disease, or uncontrolled heart failure.
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 |
|---|---|---|
| Serplulimab in combination with FruquintinibAlso: Serplulimab + FruquintinibThis intervention consists of a combination of Serplulimab, a humanized anti-PD-1 monoclonal antibody, and Fruquintinib, a selective oral inhibitor of vascular endothelial growth factor receptors (VEGFRs). Serplulimab is administered intravenously at 3 mg/kg every 3 weeks. Fruquintinib is taken orally at 5 mg daily on a 3-week-on/1-week-off schedule. The regimen is given for up to 12 months following radical nephrectomy as adjuvant therapy in patients with high-risk non-clear cell renal cell carcinoma. The dual mechanism aims to enhance anti-tumor immunity by blocking immune checkpoint inhibition while simultaneously inhibiting tumor angiogenesis. | Drug | Serplulimab + Fruquintinib Adjuvant Therapy |
Primary outcome
Overall Survival (OS)
Time frame: From the date of radical nephrectomy until death from any cause, assessed up to 60 months.
OS will be estimated using the Kaplan-Meier method and compared with historical controls.
1 secondary outcome
DFS
Time frame: From randomization until disease recurrence or death, assessed up to 60 months.
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 23 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. 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 Serplulimab in combination with Fruquintinib in people with Non-Clear Cell Renal Cell Carcinoma, run by Sun Yat-sen University 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 8 inclusion and 4 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 23 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 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?
Overall Survival (OS) (time frame: From the date of radical nephrectomy until death from any cause, assessed up to 60 months.). 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 23 Mar 2026.