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Non Clear Cell Renal CarcinomaPhase 2NCT05220267

Anlotinib Plus Sintilimab as First-line Treatment for Advanced Non Clear Cell Renal Cell Carcinoma

A Phase 2 study testing Anlotinib plus Sintilimab in people with Non Clear Cell Renal Carcinoma, run by Sun Yat-sen University 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

The combination of immune checkpoint inhibitors (ICIs) plus angiogenesis inhibitors has demonstrated significant anti-tumor activity in certain cancer. The goal of this study was to evaluate the efficacy and safety of sintilimab (a human programmed death-1 ICI) plus anlotinib (a multi-target tyrosine kinase inhibitor… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Clear Cell Renal Carcinoma
What is being tested?
Anlotinib plus Sintilimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteChina
Study dates
28 Feb 2022to 30 Dec 2026
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

  • Subjects voluntarily joined the study and signed informed consent;
  • Aged > 18 years;
  • ECOG body status score is 0 or 1,Expected survival time is greater than 3 months.
  • Locally advanced or metastatic, histological confirmed, non-clear cell RCC of all subtypes. Patients must have advanced non-clear cell of one of the following subtypes: papillary, chromophobe, collecting duct carcinoma (CDC), renal medullary carcinoma (RMC), or unclassified.
  • Patients must have measurable lesions as defined by the RECIST 1.1 standard;
  • Adequate hematologic and end-organ function as defined by the following laboratory results obtained within 28 days prior to the first study treatment:
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  • Absolute neutrophil count (ANC) ≥1.5x 109/L
  • Lymphocyte count ≥ 500/uL.
  • Platelet count ≥ 80x109/L.
  • Hemoglobin ≥ 80 g/L (patients may be transfused to meet this criterion).
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN) with the following exceptions: Patients with documented liver/bone metastases should have AST and ALT ≤ 5 x ULN.
  • Serum bilirubin ≤ 1.5 x ULN.
  • Creatinine clearance ≥ 60 mL/min.
  • For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use highly effective forms of contraception and to continue its use 4 weeks after the last dose of anlotinib or sintilimab.
  • Signed informed consent form.
  • Ability and capacity to comply with study and follow-up procedures.

Who cannot join

  • Those who are known to be allergic to pharmaceutical ingredients.
  • Receive anti-tumor monoclonal antibody or other research drugs within 4 weeks before enrollment; have received other anti-PD-1 antibody therapy or other treatment for PD-1/PD-L1;
  • Previous use of anlotinib or other angiogenesis inhibitors
  • The patient has any active autoimmune disease or a history of autoimmune disease;
  • There are uncontrolled heart clinical symptoms or diseases;
  • Patients with congenital or acquired immune deficiency;
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  • Receive chemotherapy, targeted therapy, radiotherapy within 2 weeks before enrollment;
  • A history of gastrointestinal perforation or major surgery within 4 weeks before enrollment;
  • Overactive/venous thrombosis occurred within 6 months prior to enrollment, such as cardiovascular-cerebral vascular (including transient ischemic attack),deep vein thrombosis (except for patients who have recovered from venous catheterization due to previous chemotherapy)and pulmonary embolism;
  • Those with active bleeding or bleeding tendency;
  • Presence of a drug uncontrolled hypertension;
  • Urine routine indicates more than urinary protein 2+;
  • Correct QT interval > 470msec; if the patient has a prolonged QT interval, but the investigator's study evaluates that the prolongation is due to a cardiac pacemaker (and no other abnormalities in the heart), it is necessary to discuss with the sponsor's researcher to determine if the patient is Suitable for group study;
  • Patients suspected of having other primary cancers;
  • Those who are known to be allergic to pharmaceutical ingredients.
  • Patients with active or chronic hepatitis B (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening). Patients with past/resolved HBV infection (defined as having negative HBsAg test and a positive antibody to hepatitis B core antigen [anti-HBc] antibody test) are eligible. A negative HBA DNA test must be obtained in patients with positive hepatitis B core antibody prior to Cycle 1 Day 1.
  • Active hepatitis C infection. Patients positive hepatitis C antibody test are eligible if PCR is negative for hepatitis C viral DNA.
  • Pregnant or lactating women.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer Center, Sun Yat-sen University

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

The combination of immune checkpoint inhibitors (ICIs) plus angiogenesis inhibitors has demonstrated significant anti-tumor activity in certain cancer. The goal of this study was to evaluate the efficacy and safety of sintilimab (a human programmed death-1 ICI) plus anlotinib (a multi-target tyrosine kinase inhibitor, inhibiting tumor angiogenesis and proliferative signaling) in advanced non clear cell renal cell carcinoma.

Being tested
Anlotinib plus Sintilimab

What participants receive

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

  • Anlotinib plus SintilimabDrug

    Anlotinib was taken orally (12mg qd, d1-14, 21 days per cycle).Sintilimab was administered intravenously (200mg once every 3weeks).

Study groups in NCT05220267
Study groupRoleWhat they receive
Anlotinib plus SintilimabOtherAnlotinib was taken orally (12mg qd, d1-14, 21 days per cycle) .Sintilimab was administered intravenously (200mg once every 3weeks).
Receives: Drug: Anlotinib plus Sintilimab

What is being measured

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

  1. progression-free survival (PFS)

    Time from treatment until disease progression or death

    Measured: up to 2 years

Secondary outcomes (4)

  1. objective response rate (ORR)

    objective response rate (ORR) by RECIST1.1, the total proportion of patients with complete response (CR), partial response (PR)

    Measured: up to 2 years

  2. disease control rate (DCR)

    disease control rate (DCR)by RECIST1.1, the total proportion of patients with complete response (CR), partial response (PR) and Stable Disease(SD).

    Measured: up to 2 years

  3. overall survival (OS)

    Time from treatment until death from any cause

    Measured: up to 2 years

  4. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    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 Feb 2022
  2. Study start28 Feb 2022
  3. Primary completion13 Nov 2024
  4. Study completion30 Dec 2026 (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
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05220267
Sponsor's protocol ID
SL-B2021-245-02
Status last verified
Jul 2026
First submitted
24 Dec 2021
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 1. Bray F,Ferlay J,Soerjomatarm I,et al.Global cancer statistics 2018:GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries[J].CA Cancer J Clin,2018,68(6):394-424. 2. Choueiri T,Motzer R.Systemic therapy for metastatic renal-cell carcinoma[J].N Engl J Med,2017,376(4):354-366 3. ESCUDIER B,EISEN T,STADLER W M,et al.Sorafenib in advanced clear cell renal-cell carcinoma[J].N Engl J Med,2007,356(2):125-134 4. MOTZER R J,HUTSON T E,TOMCZAK P,et al.Overall survival and updated results for sunitinib compared with interferon alfa in patients with metastatic renal cell carcinoma[J].J Clin Oncol,2009,27(22):3584-3590 5. Armstrong AJ, Halabi S, Eisen T, et al. Everolimus versus sunitinib for patients with metastatic non-clear cell renal cell carcinoma (ASPEN): a multicentre, open-label, randomised phase 2 trial. Lancet Oncol. 2016;17(3):378-388. 6. Nizar M Tannir, Eric Jonasch, Laurence Albiges, et al. Everolimus Versus Sunitinib Prospective Evaluation in Metastatic Non-Clear Cell Renal Cell Carcinoma (ESPN): A Randomized Multicenter Phase 2 Trial[J]. European Urology, 2016, 69(5):866-874. 7. Motzer RJ, Barrios CH, Kim TM, et al.: Phase II randomized trial comparing sequential first-line everolimus and second-line sunitinib versus first-line sunitinib and secondline everolimus in patients with metastatic renal cell carcinoma. J Clin Oncol 2014; 32:2765-2772. 8. Zhou AP,Bai Y,Song Y,et al. Anlotinib Versus Sunitinib as First-Line Treatment for Metastatic Renal Cell Carcinoma:A Randomized PhaseⅡClinical Trial[J]. Oncologist,2019,24(8):e702-e708. DOI:10.1634/theoncologist.2018-0839. 9. CHOUEIRI T K,FISHMAN M N,ESCUDIER B,et al.Immunomodulatory activity of nivolumab in metastatic renal cell carcinoma[J].Clin Cancer Res,2016,22(22):5461-5471. 10. MCDERMOTT D F,SOSMAN J A,SZNOL M,et al.Atezolizumab,an antiprogrammed death-ligand 1 antibody,in metastatic renal cell carcinoma:long-term safety,clinical activity,and immune correlates from a phase Ⅰa study[J].J Clin Oncol,2016,34(8):833-842. 11. Rini, BI; Plimack, ER; Stus, V; et al.Pembrolizumab plus Axitinib versus Sunitinib for Advanced Renal-Cell Carcinoma.[J].N Engl J Med.2019,380(12):1116-1127 12. YASUDA S,SHO M,YAMATO I,et al.Simultaneous blockade of programmed death 1 and vascular endothelial growth factor receptor 2 (VEGFR2) induces synergistic anti-tumour effect in vivo[J].Clin Exp Immunol,2013,172:500-506

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Anlotinib plus Sintilimab in people with Non Clear Cell Renal 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 16 inclusion and 18 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 21 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?

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 NCT05220267, which also lists 1 linked publication.

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 21 Sep 2026.

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