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Non-clear Cell Renal Cell CarcinomaPhase 2NCT05831891

Fruquintinib Plus Serplulimab as First-Line Therapy for Metastatic Non-Clear Cell Renal Cell Carcinoma

A Phase 2 study testing Fruquintinib combined with Serplulimab in people with Non-clear Cell Renal Cell Carcinoma, run by RenJi Hospital at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This multicenter, single-arm, phase II study (FRONTIER) evaluates the efficacy and safety of fruquintinib combined with serplulimab as first-line treatment in patients with metastatic or unresectable non-clear cell renal cell carcinoma (nccRCC). Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Non-clear Cell Renal Cell Carcinoma
What is being tested?
Fruquintinib combined with Serplulimab
Type of treatment
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 May 2023to 22 Oct 2030
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 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent
  • Age 18 to 85 years
  • Histologically or cytologically confirmed metastatic or unresectable nccRCC
  • At least one measurable lesion per RECIST v1.1
  • No prior systemic therapy for advanced disease
  • ECOG performance status 0-1
  • Adequate organ function
  • Life expectancy ≥3 months

Who cannot join

  • History of allergy to any component of serplulimab or fruquintinib.
  • History of or concurrent malignancy, excluding skin basal cell carcinoma, cervical carcinoma in situ, and papillary thyroid carcinoma, that has not been cured for more than 5 years or has active cancer.
  • Uncontrolled cardiac symptoms or diseases, including NYHA class II or higher heart failure, unstable angina, myocardial infarction within 1 year, or clinically significant atrial or ventricular arrhythmias requiring intervention.
  • Previous treatment with PD-1, PD-L1, or CTLA-4 antibodies; investigational drugs within 4 weeks before the first dose; enrollment in another interventional clinical trial; systemic corticosteroids (>10 mg/day prednisone equivalent) or other immunosuppressive drugs within 2 weeks before the first dose, subject to protocol-specified exceptions; antitumor or live vaccines within 4 weeks; or major surgery or serious trauma within 4 weeks.
  • Toxicity from previous anticancer therapy not recovered to CTCAE grade 1 or lower, excluding alopecia and residual neurotoxicity related to previous platinum therapy, or otherwise not meeting the eligibility criteria.
  • Serious infection (CTCAE grade >2) within 4 weeks before the first dose, including severe pneumonia, sepsis requiring hospitalization, infection-related complications, active pulmonary inflammation on baseline imaging, symptoms or signs of infection, or need for oral or intravenous antibiotics.
Show all 15Show fewer
  • Active autoimmune disease or history of autoimmune disease, subject to the protocol-specified exceptions for stable thyroid replacement, type 1 diabetes on stable insulin, vitiligo, and childhood asthma or allergy in remission.
  • History of immunodeficiency, including HIV infection, other acquired or congenital immunodeficiency, organ transplantation, or allogeneic bone marrow transplantation.
  • History of interstitial lung disease, excluding radiation pneumonitis not treated with steroids, or history of noninfectious pneumonia.
  • Evidence of active tuberculosis infection, active tuberculosis within 1 year before screening, or inadequately treated tuberculosis more than 1 year before screening.
  • Active hepatitis B or hepatitis C as defined in the protocol; eligible patients with controlled hepatitis B must receive protocol-specified antiviral therapy.
  • Known history of psychotropic substance abuse, alcoholism, or drug use.
  • Pregnant or lactating women.
  • Other factors that, in the investigator's judgment, could require withdrawal or compromise patient safety or data collection, including serious concomitant illness, significant laboratory abnormalities, or family or social factors.
  • Severe active bleeding, active peptic ulcers, unhealed gastrointestinal perforations, or gastrointestinal fistulas.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Renji Hospital

    Shanghai, Shanghai Municipality, 200123

Other trials in China

About this study

Official title: A Multicenter, Single-Arm, Phase II Study Evaluating the Efficacy and Safety of Fruquintinib Combined With Serplulimab as First-Line Treatment in Patients With Metastatic or Unresectable Non-Clear Cell Renal Cell Carcinoma

This multicenter, single-arm, phase II study (FRONTIER) evaluates the efficacy and safety of fruquintinib combined with serplulimab as first-line treatment in patients with metastatic or unresectable non-clear cell renal cell carcinoma (nccRCC). Given the biological heterogeneity and lack of established standard therapies in nccRCC, this study aims to characterize clinical outcomes and explore potential biomarkers associated with treatment benefit.

Read the detailed description

This is a prospective, multicenter, single-arm phase II study conducted in patients with metastatic or unresectable nccRCC across participating centers in China.

The study consists of a safety run-in phase followed by a cohort expansion phase. Six patients were initially enrolled in the safety run-in stage. As no dose-limiting toxicities or treatment-related deaths were observed during the predefined observation period, the study proceeded to full enrollment. A total of 40 patients were enrolled and received fruquintinib (5 mg orally once daily, 2 weeks on/1 week off) in combination with serplulimab (4.5 mg/kg intravenously every 3 weeks) as first-line systemic therapy.

Tumor assessments were performed at baseline and every 6 weeks during treatment according to RECIST version 1.1 until disease progression, death, or study discontinuation. Investigator assessment is used for the primary progression-free survival endpoint. Objective response rate, disease control rate, and duration of response are assessed by blinded independent central review.

In addition to evaluating clinical efficacy and safety, prespecified exploratory translational analyses are conducted using pretreatment tumor samples. Multiplex immunofluorescence is used to characterize the composition and spatial organization of the pretreatment tumor immune microenvironment.

Being tested
Fruquintinib combined with Serplulimab
Keywords
Fruquintinib, Serplulimab, combination therapy, first-line, non-clear cell renal cell carcinoma

What participants receive

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

  • Fruquintinib combined with SerplulimabDrug

    Also called Elunate, HLX10

    Fruquintinib 5 mg once daily, 2 weeks on/1 week off, and serplulimab 4.5 mg/kg by intravenous infusion on day 1 every 3 weeks.

Study groups in NCT05831891
Study groupRoleWhat they receive
Fruquintinib combine with SerplulimabExperimentalPatients receive fruquintinib 5 mg once daily, 2 weeks on/1 week off, combined with serplulimab 4.5 mg/kg by intravenous infusion on day 1 every 3 weeks.
Receives: Drug: Fruquintinib combined with Serplulimab

What is being measured

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

  1. Investigator-assessed progression-free survival (PFS)

    Time from treatment initiation to the first documentation of disease progression according to RECIST version 1.1, as assessed by the investigator, or death from any cause, whichever occurs first.

    Measured: Up to 2 years

Secondary outcomes (4)

  1. Objective response rate (ORR) by blinded independent central review

    Proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST version 1.1, as assessed by blinded independent central review

    Measured: Up to 2 years

  2. Disease control rate (DCR) by blinded independent central review

    Proportion of patients achieving CR, PR, or stable disease according to RECIST version 1.1, as assessed by blinded independent central review.

    Measured: Up to 2 years

  3. Adverse Event

    Incidence and severity of adverse events and treatment-related adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.

    Measured: Up to 2 years

  4. Overall Survival (OS)

    Time from treatment initiation to death from any cause

    Measured: Up to 5 years

Timeline

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

  1. First posted26 Apr 2023
  2. Study start1 May 2023
  3. Primary completion22 Oct 2027 (estimated)
  4. Study completion22 Oct 2030 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Intervention: * Fruquintinib 5 mg orally once daily (2 weeks on / 1 week off) * Serplulimab 4.5 mg/kg intravenously every 3 weeks
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05831891
Sponsor's protocol ID
FRONTIER
Status last verified
Sep 2026
First submitted
16 Apr 2023
Last updated
16 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fruquintinib combined with Serplulimab in people with Non-clear Cell Renal Cell Carcinoma, 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 8 inclusion and 15 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 16 Sep 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?

Investigator-assessed progression-free survival (PFS) (time frame: Up to 2 years). 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 NCT05831891.

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 16 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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