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Renal Cell Carcinoma (RCC)Phase 2NCT07172386

Preoperative Therapy of Super-selective Tumor Artery Embolization Combined With Toripalimab and Axitinib in Advanced RCC

A Phase 2 study testing Toripalimab and axitinib in people with Renal Cell Carcinoma (RCC), run by Tianjin Medical University Second Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a phase II study to determine the efficacy and safety of Super-selective tumor artery embolization combined with toripalimab and axitinib as treatment for patients with the advanced kidney cancer . Further evaluate whether the treatment plan is beneficial to the patient's operation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Cell Carcinoma (RCC)
What is being tested?
Toripalimab and axitinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
31 Jul 2025to 31 Jul 2027
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

  • Willing and able to provide written informed consent
  • Age ≥ 18 years
  • Patients with pathologically and radiographically confirmed renal cell carcinoma:
  • cT2N0M0 with Grade 4 or sarcomatoid feature;
  • cT3-4N0M0;
  • cTanyN1M0;
Show all 14Show fewer
  • M1 that can be returned to M0 through local therapy
  • Preoperative imaging evaluation can be performed radical excision or tumor reduction surgery
  • There are no suspected brain metastases
  • The presence of measurable lesions was assessed according to RECISTv1.1 criteria
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
  • Organ function level must meet the following requirements: Hematological indexes: neutrophil count >= 1.5x10^9/L, platelet count >= 100x10^9/L, hemoglobin >= 9.0 g/dl (can be maintained by blood transfusion); Liver function: total bilirubin <=1.5 ULN, alanine aminotransferase and aspartate aminotransferase <=1.5 ULN
  • Non-surgically sterilized or reproductive-age female patients must use a medically approved contraceptive method (such as an intrauterine device, oral contraceptives, or condoms) during the study treatment period and for 3 months after its completion; Female patients who are not surgically sterilized or are of childbearing potential must have a negative serum or urine HCG test within 7 days prior to study enrollment and must not be lactating. Male patients who are not surgically sterilized or are of childbearing potential must agree to use one medically approved contraceptive method with their spouse during the study treatment period and for 3 months after the study treatment period ends.
  • The subjects volunteered to join the study, signed informed consent, and had good compliance with follow-up

Who cannot join

  • Prior receipt of radiotherapy, chemotherapy, long-term or high-dose corticosteroid therapy, surgery, or molecular targeted therapy
  • Subjects with a history of or concurrent other malignancies (except those controllable and not affecting 2-year survival)
  • Prior treatment with other PD-1/PD-L1 therapies; Known history of allergy to macromolecular protein preparations or any known PD-1 component
  • Active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; Subjects with vitiligo or childhood asthma that has achieved complete remission without requiring any intervention in adulthood may be included; subjects requiring medical intervention with bronchodilators for asthma are excluded);
  • Subjects currently using immunosuppressive agents for immunosuppression purposes and continuing such use within 2 weeks prior to enrollment
  • Uncontrolled cardiac clinical symptoms or diseases, such as:
Show all 22Show fewer
  • New York Heart Association (NYHA) Class II or higher heart failure;
  • Unstable angina;
  • Myocardial infarction within the past year;
  • Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention
  • Coagulation abnormalities (PT > 16s, APTT > 43s, TT > 21s, Fbg > 2g/L) with bleeding tendency or currently receiving thrombolytic or anticoagulant therapy;
  • Active gastrointestinal bleeding within 3 months prior to first dose due to esophageal varices, active gastric or duodenal ulcer, ulcerative colitis, portal hypertension, or unresected tumors; or other conditions judged by the investigator to potentially cause gastrointestinal bleeding or perforation
  • History or current presence of major bleeding (≥30 mL within 3 months), hemoptysis (≥5 mL fresh blood within 4 weeks), or thromboembolic events (including stroke and/or transient ischemic attack) within 12 months
  • Active infection or unexplained fever >38.5°C occurring during screening or prior to first dose
  • History of abdominal fistula, gastrointestinal perforation, or abdominal abscess within 4 weeks prior to first dose
  • Objective evidence of past or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, or severe pulmonary impairment
  • Subjects with congenital or acquired immunodeficiency, such as HIV infection, or active hepatitis (transaminase levels not meeting inclusion criteria; for hepatitis B: HBV DNA ≥10⁴/ml; for hepatitis C: HCV RNA ≥10³/ml); chronic hepatitis B virus carriers with HBV DNA ≥2000 IU/ml (≥10⁴ copies/ml) must concurrently receive antiviral therapy during the study to be eligible for enrollment
  • Subjects currently participating in other clinical studies or those who completed a prior clinical study within the past month; subjects may receive other systemic antitumor therapies during the study period
  • Administration of live vaccines within 4 weeks prior to study drug initiation or during the study period
  • Known history of psychiatric drug abuse, alcoholism, or substance abuse;
  • Inability or refusal to bear out-of-pocket costs for examinations and treatments
  • The investigator deems the subject should be excluded from this study, such as when the investigator determines the subject has other factors that may necessitate premature termination of the study, including: other serious illnesses (including psychiatric disorders) requiring concomitant treatment, severe laboratory abnormalities, or family/social factors that may compromise subject safety or interfere with data/sample collection.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Shimiao Zhu, MD,PhD contact

+86 88328607

zhushimiao@tmu.edu.cn

China1 site, 1 recruiting

  • Tianjin Medical University Second Hospital

    Tianjin, Tianjin Municipality, 300211

    Changyi Quan, PhD, 13388067990, 345920147@qq.com

    Recruiting

Other trials in China

About this study

Official title: A Study on the Safety and Efficacy of Super-selective Tumour Arterial Embolisation in Combination With Toripalimab and Axitinib as a Preoperative Treatment for Advanced Renal Cell Carcinoma

This is a phase II study to determine the efficacy and safety of Super-selective tumor artery embolization combined with toripalimab and axitinib as treatment for patients with the advanced kidney cancer . Further evaluate whether the treatment plan is beneficial to the patient's operation. Patients will undergo super-selective embolization of the feeding arteries to the renal tumour one week prior to drug therapy, followed by toripalimab administered every three weeks for three to four consecutive cycles combined with axitinib administered for four consecutive cycles in the preoperative and patients need to continue taking the drug for a year after surgery

Read the detailed description

This is a phase II study to determine the efficacy and safety of Super-selective tumor artery embolization combined with toripalimab and axitinib as treatment for patients with the advanced kidney cancer . Further evaluate whether the treatment plan is beneficial to the patient's operation. Patients will undergo super-selective embolization of the feeding arteries to the renal tumour one week prior to drug therapy, followed by toripalimab administered every three weeks for three to four consecutive cycles combined with axitinib administered for four consecutive cycles in the preoperative and patients need to continue taking the drug for a year after surgery, The main objective of the study was to evaluate whether the treatment was beneficial to patients undergoing surgery.

Being tested
Toripalimab and axitinib
Keywords
Toripalimab, Axitinib, Super-selective renal artery embolization, Advanced Renal Cell Carcinoma
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.

  • Toripalimab and axitinibDrug

    Also called Super-selective tumor arterial embolization

    Patients will undergo super-selective embolization of the feeding arteries to the renal tumour one week prior to drug therapy, followed by toripalimab administered every three weeks for four consecutive cycles combined with axitinib administered for four consecutive cycles before surgery, and followed by 17 cycles' toripalimab for adjuvant therapy.

Study groups in NCT07172386
Study groupRoleWhat they receive
Embolization plus toripalimab and axitinibExperimentalPatients will undergo super-selective embolization of the feeding arteries to the renal tumour one week prior to drug therapy, followed by toripalimab administered every three weeks for four consecutive cycles combined with axitinib administered for four consecutive cycles in the preoperative and patients need to continue taking the drug for a year after surgery
Receives: Drug: Toripalimab and axitinib

What is being measured

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

  1. R0 Resection Rate

    The proportion of patients who achieve complete resection with no residual tumor cells detected at the surgical margin, serving as a primary outcome measure to assess the success of surgical intervention in the study.

    Measured: through study completion, an average of 3 year

  2. ORR

    According to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, the objective response rate (ORR) following preoperative treatment was assessed by the investigator.

    Measured: through study completion, an average of 3 year

  3. Preoperative Treatment Safety: Treatment-Related Side Effects

    Treatment-Related Side Effects

    Measured: Through treatment completion (before surgery), an average of 4 cycles (each cycle is 21 days)

Secondary outcomes (5)

  1. Perioperative Complications

    Intraoperative Blood Loss, Karnofsky Score, and Hospital Stay

    Measured: Throughout treatment until 30 days after surgery

  2. Progression free survival

    Progression free survival was assessed by imaging (enhanced CT, enhanced MRI or both ) after surgery every 12 weeks until 12 months.

    Measured: Every 12 weeks until 12 months after surgery

  3. Major Pathological Response

    Defined as ≤10% residual viable tumor cells in the resected tumor specimen (assessed by pathological examination after surgery). Serves as a secondary outcome to evaluate the effectiveness of preoperative therapy in reducing tumor burden at the pathological level.

    Measured: Within 14 days after surgical resection

  4. Patient-Reported Quality of Life

    EORTC QLQ-C30 and FKSI-15 Scores

    Measured: Through adjuvant treatment completion (after surgery), with assessments once every 3 weeks for a total of 17 cycles (each cycle is 21 days)

  5. Overall Survival (OS)

    Subjects will undergo survival follow-up until the earliest occurrence of the following events: subject death, loss to follow-up, withdrawal of informed consent, completion of 5 years of survival follow-up, or study termination.

    Measured: Follow-up is performed once every 3 months (±14 days)

Timeline

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

  1. First posted15 Sep 2025
  2. Study start31 Jul 2025
  3. Primary completion31 Jul 2026 (estimated)
  4. Study completion31 Jul 2027 (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
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07172386
Sponsor's protocol ID
SETAR
Status last verified
Sep 2025
First submitted
8 Sep 2025
Last updated
16 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • ournal/Source：Presented at: American Society of Clinical Oncology - Genitourinary Cancers Symposium (ASCO - GU) 2025 • Publication Year：2025 • Other Info：Abstract #477684

  • Muller A, Rouviere O. Renal artery embolization-indications, technical approaches and outcomes. Nat Rev Nephrol. 2015 May;11(5):288-301. doi: 10.1038/nrneph.2014.231. Epub 2014 Dec 23.

    PubMed 25536394

  • Rothrock NE, Jensen SE, Beaumont JL, Abernethy AP, Jacobsen PB, Syrjala K, Cella D. Development and initial validation of the NCCN/FACT symptom index for advanced kidney cancer. Value Health. 2013 Jul-Aug;16(5):789-96. doi: 10.1016/j.jval.2013.04.015. Epub 2013 Jun 19.

    PubMed 23947972

  • EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.

    PubMed 10109801

  • Powles T, Plimack ER, Soulieres D, Waddell T, Stus V, Gafanov R, Nosov D, Pouliot F, Melichar B, Vynnychenko I, Azevedo SJ, Borchiellini D, McDermott RS, Bedke J, Tamada S, Yin L, Chen M, Molife LR, Atkins MB, Rini BI. Pembrolizumab plus axitinib versus sunitinib monotherapy as first-line treatment of advanced renal cell carcinoma (KEYNOTE-426): extended follow-up from a randomised, open-label, phase 3 trial. Lancet Oncol. 2020 Dec;21(12):1563-1573. doi: 10.1016/S1470-2045(20)30436-8. Epub 2020 Oct 23.

    PubMed 33284113

  • Motzer RJ, Hutson TE, Cella D, Reeves J, Hawkins R, Guo J, Nathan P, Staehler M, de Souza P, Merchan JR, Boleti E, Fife K, Jin J, Jones R, Uemura H, De Giorgi U, Harmenberg U, Wang J, Sternberg CN, Deen K, McCann L, Hackshaw MD, Crescenzo R, Pandite LN, Choueiri TK. Pazopanib versus sunitinib in metastatic renal-cell carcinoma. N Engl J Med. 2013 Aug 22;369(8):722-31. doi: 10.1056/NEJMoa1303989.

    PubMed 23964934

  • Motzer RJ, Tannir NM, McDermott DF, Aren Frontera O, Melichar B, Choueiri TK, Plimack ER, Barthelemy P, Porta C, George S, Powles T, Donskov F, Neiman V, Kollmannsberger CK, Salman P, Gurney H, Hawkins R, Ravaud A, Grimm MO, Bracarda S, Barrios CH, Tomita Y, Castellano D, Rini BI, Chen AC, Mekan S, McHenry MB, Wind-Rotolo M, Doan J, Sharma P, Hammers HJ, Escudier B; CheckMate 214 Investigators. Nivolumab plus Ipilimumab versus Sunitinib in Advanced Renal-Cell Carcinoma. N Engl J Med. 2018 Apr 5;378(14):1277-1290. doi: 10.1056/NEJMoa1712126. Epub 2018 Mar 21.

    PubMed 29562145

  • Zhang Z, Xiong L, Wu Z, Liu H, Ning K, Peng Y, Yu C, Ding Y, Weng D, Xia J, Jiang L, Guo S, Han H, Zhou F, Dong P. Neoadjuvant combination of pazopanib or axitinib and programmed cell death protein-1-activated dendritic cell-cytokine-induced killer cells immunotherapy may facilitate surgery in patients with renal cell carcinoma. Transl Androl Urol. 2021 May;10(5):2091-2102. doi: 10.21037/tau-21-406.

    PubMed 34159090

  • Liu J, Blake SJ, Yong MC, Harjunpaa H, Ngiow SF, Takeda K, Young A, O'Donnell JS, Allen S, Smyth MJ, Teng MW. Improved Efficacy of Neoadjuvant Compared to Adjuvant Immunotherapy to Eradicate Metastatic Disease. Cancer Discov. 2016 Dec;6(12):1382-1399. doi: 10.1158/2159-8290.CD-16-0577. Epub 2016 Sep 23.

    PubMed 27663893

  • Gorin MA, Patel HD, Rowe SP, Hahn NM, Hammers HJ, Pons A, Trock BJ, Pierorazio PM, Nirschl TR, Salles DC, Stein JE, Lotan TL, Taube JM, Drake CG, Allaf ME. Neoadjuvant Nivolumab in Patients with High-risk Nonmetastatic Renal Cell Carcinoma. Eur Urol Oncol. 2022 Feb;5(1):113-117. doi: 10.1016/j.euo.2021.04.002. Epub 2021 May 26.

    PubMed 34049847

  • Chapin BF, Delacroix SE Jr, Culp SH, Nogueras Gonzalez GM, Tannir NM, Jonasch E, Tamboli P, Wood CG. Safety of presurgical targeted therapy in the setting of metastatic renal cell carcinoma. Eur Urol. 2011 Nov;60(5):964-71. doi: 10.1016/j.eururo.2011.05.032. Epub 2011 May 25.

    PubMed 21621907

  • Borregales LD, Adibi M, Thomas AZ, Wood CG, Karam JA. The role of neoadjuvant therapy in the management of locally advanced renal cell carcinoma. Ther Adv Urol. 2016 Apr;8(2):130-41. doi: 10.1177/1756287215612962. Epub 2015 Nov 20.

    PubMed 27034725

  • Motzer RJ, Ravaud A, Patard JJ, Pandha HS, George DJ, Patel A, Chang YH, Escudier B, Donskov F, Magheli A, Carteni G, Laguerre B, Tomczak P, Breza J, Gerletti P, Lechuga M, Lin X, Casey M, Serfass L, Pantuck AJ, Staehler M. Adjuvant Sunitinib for High-risk Renal Cell Carcinoma After Nephrectomy: Subgroup Analyses and Updated Overall Survival Results. Eur Urol. 2018 Jan;73(1):62-68. doi: 10.1016/j.eururo.2017.09.008. Epub 2017 Sep 28.

    PubMed 28967554

  • Gross-Goupil M, Kwon TG, Eto M, Ye D, Miyake H, Seo SI, Byun SS, Lee JL, Master V, Jin J, DeBenedetto R, Linke R, Casey M, Rosbrook B, Lechuga M, Valota O, Grande E, Quinn DI. Axitinib versus placebo as an adjuvant treatment of renal cell carcinoma: results from the phase III, randomized ATLAS trial. Ann Oncol. 2018 Dec 1;29(12):2371-2378. doi: 10.1093/annonc/mdy454.

    PubMed 30346481

  • Motzer RJ, Haas NB, Donskov F, Gross-Goupil M, Varlamov S, Kopyltsov E, Lee JL, Melichar B, Rini BI, Choueiri TK, Zemanova M, Wood LA, Reaume MN, Stenzl A, Chowdhury S, Lim HY, McDermott R, Michael A, Bao W, Carrasco-Alfonso MJ, Aimone P, Voi M, Doehn C, Russo P, Sternberg CN; PROTECT investigators. Randomized Phase III Trial of Adjuvant Pazopanib Versus Placebo After Nephrectomy in Patients With Localized or Locally Advanced Renal Cell Carcinoma. J Clin Oncol. 2017 Dec 10;35(35):3916-3923. doi: 10.1200/JCO.2017.73.5324. Epub 2017 Sep 13.

    PubMed 28902533

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Toripalimab and axitinib in people with Renal Cell Carcinoma (RCC), run by Tianjin Medical University Second 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 14 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: looking for participants now, as of the sponsor's last update on 16 Sep 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?

Contact Shimiao Zhu, MD,PhD (+86 88328607, zhushimiao@tmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

R0 Resection Rate (time frame: through study completion, an average of 3 year). The study lists 3 primary outcomes in all. 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 NCT07172386, which also lists 19 linked publications.

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 2025.

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