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Non-Clear Cell Renal Cell Carcinoma (nccRCC)Phase 3SerF-ADJNCT07904156

A Phase III Randomized Controlled Trial of Serplulimab Plus Fruquintinib as Adjuvant Therapy for High-Risk Non-Clear Cell Renal Cell Carcinoma

A Phase 3 study testing Serplulimab + Fruquintinib in people with Non-Clear Cell Renal Cell Carcinoma (nccRCC), run by Sun Yat-sen University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

People with non-clear cell renal cell carcinoma may remain at high risk of cancer recurrence even after surgery has removed all visible disease. This study will test whether treatment after surgery with serplulimab plus fruquintinib improves outcomes compared with observation alone. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Serplulimab + Fruquintinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
No sites listed yet
Study dates
21 Oct 2026to 30 Dec 2032
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 provides written informed consent and is willing and able to comply with study procedures.
  • Is 18 to 80 years of age, inclusive.
  • Has an Eastern Cooperative Oncology Group performance status of 0 or 1 and a life expectancy of at least 3 months.
  • Has histologically confirmed high-risk non-clear cell renal cell carcinoma, including papillary, unclassified, or genetically defined non-clear cell subtypes. High-risk disease is defined according to the AJCC 8th edition as newly diagnosed T2 disease with sarcomatoid differentiation; T2 grade 4 disease; T3NxM0, T4NxM0, or TxN1M0 disease; or recurrent or metastatic renal cell carcinoma (TxNxM1) that has undergone R0 resection.
  • Signs informed consent no more than 12 weeks after surgery.
  • Has no definite evidence of tumor on physical examination and baseline imaging of the brain, chest, abdomen, and pelvis (CT or MRI), or whole-body PET-CT.
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  • Has no definite evidence of bone metastasis on bone scan.
  • Has adequate organ function, defined as:
  • Hemoglobin ≥70 g/L; absolute neutrophil count ≥1.5 × 10^9/L; white blood cell count ≥3.0 × 10^9/L; and platelet count ≥80 × 10^9/L.
  • ALT and AST ≤2.5 × the upper limit of normal (ULN), or ≤5 × ULN in the circumstances specified in the protocol for liver or bone metastases; total bilirubin ≤1.5 × ULN.
  • Serum creatinine ≤2 × ULN or creatinine clearance ≥30 mL/min.
  • Activated partial thromboplastin time, international normalized ratio, and prothrombin time ≤1.5 × ULN.
  • If of childbearing potential, has a confirmed nonpregnant status before enrollment. All participants agree to use adequate contraception during treatment and for 6 months after treatment ends.

Who cannot join

  • Chromophobe renal cell carcinoma, collecting duct carcinoma, or renal medullary carcinoma.
  • Known hypersensitivity to either study drug, its active ingredient, or any excipient.
  • Prior treatment with an antitumor monoclonal antibody or another investigational drug, including prior anti-PD-1 or anti-PD-L1 therapy.
  • Inability to start study treatment within 12 weeks after surgery.
  • Prior treatment with fruquintinib or another antiangiogenic drug.
  • Use of immunosuppressive medication or systemic corticosteroids at a dose greater than 10 mg/day prednisone equivalent within 2 weeks before enrollment.
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  • Current or previous active autoimmune disease, except for the conditions expressly permitted by the protocol, including certain conditions requiring no systemic treatment during the preceding 2 years and stable endocrine conditions controlled with replacement therapy.
  • Uncontrolled cardiac symptoms or disease, congenital or acquired immunodeficiency, or uncontrolled hypertension despite medication.
  • Prior use of traditional Chinese medicine with an established anticancer indication before enrollment.
  • Gastrointestinal perforation within 4 weeks before enrollment; a serious arterial or venous thrombotic event within 6 months before enrollment; or active bleeding or a bleeding tendency.
  • Urine protein of 3+ or greater on dipstick testing, or 24-hour urine protein ≥2 g.
  • Suspected additional primary malignancy.
  • Interstitial lung disease, noninfectious pneumonitis, or an uncontrolled systemic illness.
  • Receipt of a live attenuated vaccine within 28 days before the first study-drug dose, or anticipated need for one during the study.
  • HIV infection or known AIDS; active hepatitis B (HBV DNA ≥500 IU/mL); active hepatitis C (detectable HCV RNA); or concurrent hepatitis B and C infection.
  • Severe infection within 4 weeks before the first study-drug dose; grade ≥2 active infection requiring systemic antibiotics within 2 weeks before the first dose; unexplained fever >38.5°C during screening or before the first dose, unless judged by the investigator to be tumor-related; or evidence of active tuberculosis within the preceding year.
  • Major surgery within 28 days before randomization, except for the procedures expressly permitted by the protocol.
  • Prior or planned allogeneic bone marrow or solid-organ transplantation.
  • Grade ≥2 peripheral neuropathy; active brain or meningeal metastases, carcinomatous meningitis, or spinal cord compression. The protocol permits previously treated brain metastases under specified stability and imaging conditions.
  • A condition that substantially impairs absorption of oral medication, such as inability to swallow, chronic diarrhea, or clinically significant bowel obstruction.
  • Pregnancy, breastfeeding, or plans to become pregnant during the study.
  • Any other serious physical or psychiatric illness or laboratory abnormality that may increase study risk, interfere with interpretation of results, or make participation unsuitable in the investigator's judgment.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Pei Dong, Doc contact

+8618684843267

dongpei@sysucc.org.cn

About this study

Official title: A Randomized, Controlled, Multicenter Phase III Study of Serplulimab Plus Fruquintinib Versus Observation as Adjuvant Treatment for Patients With High-Risk Non-Clear Cell Renal Cell Carcinoma

People with non-clear cell renal cell carcinoma may remain at high risk of cancer recurrence even after surgery has removed all visible disease. This study will test whether treatment after surgery with serplulimab plus fruquintinib improves outcomes compared with observation alone.

This is a multicenter, randomized, open-label Phase III study. Approximately 108 adults will be assigned in a 1:1 ratio to receive the drug combination or observation. Participants in both groups will undergo scheduled follow-up. The main measure is the proportion of participants who remain free of recurrence two years after randomization. The study will also assess recurrence-free survival over time, overall survival, safety, and exploratory biomarkers.

Read the detailed description

This prospective, multicenter, randomized Phase III study will evaluate serplulimab plus fruquintinib as adjuvant treatment for patients with high-risk non-clear cell renal cell carcinoma after surgical removal of all visible disease. The study hypothesis is that the combination will improve recurrence-free survival compared with observation.

Approximately 108 eligible participants will be randomized 1:1 to the combination-treatment group or the observation group. Treatment in the experimental group will begin within 12 weeks after surgery. The observation group will receive no study drug. Both groups will undergo scheduled clinical and imaging assessments, generally every 12 weeks, to monitor for recurrence and survival. The study will assess treatment safety and explore whether biomarkers measured in tumor tissue and blood are associated with outcomes.

Being tested
Serplulimab + Fruquintinib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Serplulimab + FruquintinibDrug

    Participants will start adjuvant treatment within 12 weeks after surgery. Serplulimab 300 mg will be administered by intravenous infusion every 3 weeks for up to 17 cycles. Fruquintinib 5 mg will be taken orally once daily for 14 days, followed by 7 days off, for a total of 12 weeks.

Study groups in NCT07904156
Study groupRoleWhat they receive
Serplulimab Plus FruquintinibExperimentalParticipants will start adjuvant treatment within 12 weeks after surgery. Serplulimab 300 mg will be administered by intravenous infusion every 3 weeks for up to 17 cycles. Fruquintinib 5 mg will be taken orally once daily for 14 days, followed by 7 days off, for a total of 12 weeks.
Receives: Drug: Serplulimab + Fruquintinib
ObservationNo interventionParticipants will receive no adjuvant study treatment after surgery. They will undergo scheduled clinical and imaging assessments every 12 weeks to monitor for disease recurrence and survival.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 2-Year Recurrence-Free Survival (RFS) Rate

    The Kaplan-Meier estimated percentage of randomized participants who are alive without documented local, regional, or distant recurrence 24 months after randomization.

    Measured: 2-year

Secondary outcomes (2)

  1. Overall Survival (OS)

    Time from randomization to death from any cause. Participants alive at their last known follow-up will be censored on that date.

    Measured: 2-year

  2. Incidence and Severity of Adverse Events

    Number and percentage of participants receiving study treatment who experience adverse events, summarized by severity.

    Measured: From the date of informed consent until 90 days after the last dose of serplulimab or 30 days after the last dose of fruquintinib, whichever is later, or until the initiation of new anticancer therapy, whichever occurs first; assessed up to 27 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2026
  2. Study start21 Oct 2026 (estimated)
  3. Primary completion30 Dec 2030 (estimated)
  4. Study completion30 Dec 2032 (estimated)

Resources

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
Model description
Participants will be randomized 1:1 to two parallel groups: adjuvant serplulimab plus fruquintinib or observation without study drug. This is a multicenter, open-label study. Both groups will follow the same scheduled assessment plan.
Masking
None (open label)
Enrolment
108 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07904156
Sponsor's protocol ID
SerF-ADJnRCC-01
Other IDs
2025-FXY-300-urology
Acronym
SerF-ADJ
Status last verified
Oct 2026
First submitted
19 Oct 2026
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be publicly shared due to patient privacy and confidentiality considerations, as well as ethical and regulatory restrictions. The study data will be securely maintained by the investigators and used in accordance with the approved study protocol and applicable regulations.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Serplulimab + Fruquintinib in people with Non-Clear Cell Renal Cell Carcinoma (nccRCC), run by Sun Yat-sen 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 22 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 29 Oct 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 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 Pei Dong, Doc (+8618684843267, dongpei@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

2-Year Recurrence-Free Survival (RFS) Rate (time frame: 2-year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07904156.

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 29 Oct 2026.

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