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Renal Cell Carcinoma (RCC)Phase 2NCT07047001

Vorolanib Monotherapy or in Combination With Toripalimab as Adjuvant Therapy for Patients With Intermediate-high Risk of Recurrence in Renal Cell Carcinoma

A Phase 2 study testing Vorolanib Tablets and Vorolanib + Toripalimab in people with Renal Cell Carcinoma (RCC) and Adjuvant, run by Dong Wen 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

While the 5-year survival rate for localized renal cell carcinoma (RCC) approaches 80%-95%, patients with high-risk non-metastatic disease face a substantial 30%-40% risk of recurrence/metastasis within 5 years. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Cell Carcinoma (RCC), Adjuvant
What is being tested?
Vorolanib Tablets and Vorolanib + Toripalimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
24 Apr 2025to 30 Jun 2032
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

  • Has histologically confirmed diagnosis of localized and locally advanced stage renal cell carcinoma (RCC), with moderate to high recurrence risk
  • Has intermediate-high risk, high risk, or M1 no evidence of disease (NED) RCC as defined by the following pathological tumor-node-metastasis and Fuhrman grading status:
  • Intermediate-high risk RCC: pT1b-T2, Grade 4 or sarcomatoid, N0, M0; pT3, Any Grade, N0, M0;
  • High risk RCC: pT4, Any Grade N0, M0; pT Any stage, Any Grade, N+, M0 M1 NED RCC participants who present not only with the primary kidney tumor but also solid, isolated, soft tissue metastases that can be completely resected at one of the following: the time of nephrectomy (synchronous) or, ≤1 year from nephrectomy (metachronous)
  • Have adequate tissue for PD-L1 testing 0Has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1
  • Expected survival ≥ 12 months;
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  • Participants of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study treatment through 120 days after the last dose of study treatment
  • Has adequate organ function
  • Be able to understand and willing to sign the informed consent form

Who cannot join

  • Patients with advanced/metastatic renal cell carcinoma (RCC) or non-clear cell renal cell carcinoma (nccRCC).
  • Prior exposure to any anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibodies, or other agents specifically targeting T-cell co-stimulation checkpoints, or small molecule anti-angiogenic drugs.
  • Subjects who underwent major surgery or chemotherapy within 4 weeks prior to the first dose administration, or those with postoperative duration >12 weeks who received major surgery/chemotherapy within 4 weeks before first dosing.
  • Subjects with hypersensitivity to study drugs.
  • Active hemorrhage, ulceration, intestinal perforation, bowel obstruction, or uncontrolled hypertension (defined as BP >140/90 mmHg or unstable during screening).
  • Uncontrolled adrenal insufficiency.
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  • Congenital/acquired immunodeficiency (e.g., HIV infection) or active hepatitis:
  • HBV: HBsAg+ with HBV DNA ≥2000 IU/mL (≥10⁴ copies/mL) HCV: Anti-HCV+ with viral load >ULN
  • Active autoimmune diseases (including but not limited to autoimmune hepatitis, interstitial lung disease, uveitis, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism) or history of autoimmune diseases. Exceptions: Vitiligo or childhood asthma fully resolved without intervention in adulthood.
  • Symptomatic visceral metastases with imminent life-threatening complications (e.g., uncontrolled exudation [pleural/pericardial/abdominal], lymphangitic carcinomatosis, or >30% liver involvement).
  • Severe infections requiring IV antibiotics/antifungals/antivirals within 4 weeks prior to first dose, or unexplained fever >38.5°C during screening.
  • History of other malignancies within 5 years.
  • Systemic corticosteroids or immunosuppressants within 14 days before first study drug administration.
  • Documented active tuberculosis (Mycobacterium tuberculosis).
  • Concurrent use of experimental agents or standard antineoplastic therapies.
  • Active infections.
  • High bleeding risk.
  • Comorbidities (e.g., cardiopulmonary insufficiency) precluding radical nephrectomy/partial nephrectomy under general anesthesia.
  • Pregnant/lactating women.
  • Other conditions affecting trial conduct or interpretation (e.g., severe psychiatric disorders).

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510120

Other trials in China

About this study

Official title: The Efficacy and Safety of Vorolanib Monotherapy or in Combination With Toripalimab for Postoperative Adjuvant Treatment of Renal Cell Carcinoma Patients With Intermediate-high Risk Recurrence Factors: A Multicenter, Randomized, Double-arm, Phase II Exploratory Study

While the 5-year survival rate for localized renal cell carcinoma (RCC) approaches 80%-95%, patients with high-risk non-metastatic disease face a substantial 30%-40% risk of recurrence/metastasis within 5 years. Emerging evidence demonstrates that combining anti-angiogenic agents with immune checkpoint inhibitors significantly extends progression-free survival (PFS) in first-line advanced/metastatic RCC settings. To address the unmet need for adjuvant strategies in intermediate/high-risk localized RCC, we propose a synergistic approach leveraging targeted therapy and immunotherapy. This dual-modality regimen may delay resistance mechanisms while enhancing disease-free survival (DFS) and overall survival (OS).

Vorolanib, a next-generation vascular endothelial growth factor receptor (VEGFR)-targeted tyrosine kinase inhibitor (TKI), exhibits unique pharmacodynamic properties that warrant investigation in adjuvant paradigms. This study evaluates two experimental arms: (1) Vorolanib combined with toripalimab, a PD-1 inhibitor. (2) Vorolanib monotherapy. This study aims to evaluate the efficacy and safety of vorolanib combined with toripalimab or vorolanib monotherapy in postoperative adjuvant therapy for intermediate/high-risk non-metastatic locally advanced renal cell carcinoma (RCC), while also investigating the correlation between postoperative minimal residual disease (MRD)-positive status and recurrence risk.

Being tested
Vorolanib Tablets, Vorolanib + Toripalimab
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.

  • Vorolanib TabletsDrug

    Also called CM082

    200mg PO QD

  • Vorolanib + ToripalimabDrug

    Also called Toripalimab: JS001, Vorolanib:CM082

    Vorolanib: 100mg PO QD

    Toripalimab: 240mg IV infusion Q3W

Study groups in NCT07047001
Study groupRoleWhat they receive
monotherpyExperimentalParticipants only received vorolanib as an adjuvant treatment.
Receives: Drug: Vorolanib Tablets
combination therapyExperimentalParticipants received vorolanib combined with toripalimab as adjuvant therapy.
Receives: Drug: Vorolanib + Toripalimab

What is being measured

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

  1. 2-y DFS

    The proportion of patients who did not experience local recurrence/transfer or died for any reason within 2 years among all patients, per RECIST or irRECIST

    Measured: From enrollment to the recurrence or metastasis or death(based on the first occurrence) at 2 years

Secondary outcomes (5)

  1. DFS

    The period from the date of enrollment until local recurrence or distant metastasis occurs, or until death due to any cause, shall be measured from the earlier of the two events, per RECIST 1.1 and irRECIST

    Measured: From date of enrollment until the date of local recurrence or distant metastasis occurs, or date of death from any cause ,whichever came first,assessed up to 100 months

  2. OS

    The period from the date of enrollment until the date of death due to any cause

    Measured: From date of enrollment to death due to any cause,assessed up to 120 months

  3. Safety and tolerability

    The proportion of patients experiencing adverse events among the total patients, per CTCEA v5.0

    Measured: 1 year

  4. The correlation between MRD positivity and recurrence

    The correlation between postoperative MRD (Minimal Residual Disease) positive status and postoperative recurrence

    Measured: up to 2 years

  5. Correlation between molecular characteristics and therapeutic efficacy

    Calculate the MRD positive rate of the patients.All of the patients were divided into negative group and positive group based on the MRD status.Evaluate the RFS of the two groups separately, and the evaluation index was the hazard ratio（HR）value.

    Measured: up to 2 years

Timeline

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

  1. First posted2 Jul 2025
  2. Study start24 Apr 2025
  3. Primary completion30 Jun 2029 (estimated)
  4. Study completion30 Jun 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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07047001
Sponsor's protocol ID
SYSKY-2025-146-01
Status last verified
Jun 2025
First submitted
5 Jun 2025
Last updated
9 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vorolanib Tablets and Vorolanib + Toripalimab in people with Renal Cell Carcinoma (RCC) and Adjuvant, run by Dong Wen 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 9 inclusion and 20 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 9 Jul 2025. 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?

2-y DFS (time frame: From enrollment to the recurrence or metastasis or death(based on the first occurrence) at 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 NCT07047001.

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 9 Jul 2025.

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