AzTrials
AzTrials

Renal Cell CarcinomaPhase 2SAARCCNCT04958473

A Study of Sintilimab in Combination With Axitinib in Advanced Renal Cell Cancer

A Phase 2 study testing Sintilimab and Axitinib in people with Renal Cell Carcinoma and Clear Cell Renal Cell Carcinoma, run by Tianjin Medical University Second Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

In patients with recurrent or metastatic renal cell carcinoma, a preliminary evaluation of the safety and efficacy of sintilimab combined with axitinib in patients with advanced renal cell carcinoma was conducted.Progression-free survival (PFS), overall survival (OS), disease control rate (DCR) and disease remission… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Sintilimab and Axitinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
1 Aug 2021to 1 Aug 2025
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Signed written informed consent before performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up
  • Diagnosis of locally advanced or metastatic RCC that is predominantly clear cell histology
  • Must have measurable disease
  • Subject has received no prior systemic therapy
  • A woman is eligible to participate in the study if she is of Non-childbearing potential, has a negative serum pregnancy test within 7 days of the first dose of study treatment, not lactating, and agrees to use adequate contraception during the study until at least 120 days after the last dose of investigational product
  • Eastern Cooperative Oncology Group performance status 0 or 1
  • Adequate organ function as defined in the protocol
  • Left ventricular ejection fraction >= lower limit of normal as assessed by echocardiogram or multigated acquisition scan

Who cannot join

  • Subject has an active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents
  • Subject is currently participating or has participated in a study of an investigational agent or using an investigational device within 30 days of the first dose of study treatment
  • Subject is expected to require any other form of systemic or localized antineoplastic therapy while on study
  • Subject is on any systemic steroid therapy, within one week before the planned date for first dose of study treatment. Subject is on any other form of immunosuppressive medication
  • Unable to swallow and retain orally administered medication
  • Active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or other -Gastrointestinal conditions with increased risk of perforation; history of abdominal fistula, GI perforation, or intra-abdominal abscess within 4 weeks before beginning study treatment
Show all 17Show fewer
  • Known history of HIV infection or a known history of or is positive for Hepatitis B or Hepatitis C
  • Presence of active infection requiring systemic therapy
  • Corrected QT interval duration prolongation
  • History of any one or more of the following cardiac conditions within the past 6 months: Cardiac angioplasty or stenting; Myocardial infarction; Unstable angina; ----History of Class III or IV congestive heart failure according to New York Heart Association classification
  • History of cerebrovascular accident within the past 6 months
  • Poorly controlled hypertension
  • History of untreated deep venous thrombosis
  • Presence of any non-healing wound, fracture, or ulcer, or presence of symptomatic peripheral vascular disease
  • Evidence of bleeding diathesis or coagulopathy
  • Any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures
  • Has taken any prohibited medications that are listed in the protocol within 14 days of the first dose of study treatment. Subject has received or will receive a live vaccine within 30 days before the first administration of study treatment

Trial locations and contacts

1 site in 1 country.

BIN HUO, MD contact

+86 22 88326610

huobin_doctor@icloud.com

China1 site

  • Tianjin Medical Unversity Second Hospital

    Tianjin, Tianjin Municipality, 300211

    BIN HUO, MD, +86 22 88326610, huobin_doctor@icloud.com

Other trials in China

About this study

Official title: A Single-center, Non-randomized Controlled, Single-arm, Phase II Clinical Trial of Sintilimab in Combination With Axitinib in the Treatment of Advanced Renal Cell Carcinoma

In patients with recurrent or metastatic renal cell carcinoma, a preliminary evaluation of the safety and efficacy of sintilimab combined with axitinib in patients with advanced renal cell carcinoma was conducted.Progression-free survival (PFS), overall survival (OS), disease control rate (DCR) and disease remission rate (ORR) were evaluated.

Read the detailed description

Patients with recurrent or metastatic renal cell carcinoma received axitinib tablets (5mg bid po) combined with sintilimab (200mg d1) on a 3-week (21-day) as a one-cycle regimen.6 months of continuous administration (i.e., 8 cycles of sintilimab) or until tumor progression or unacceptable toxicity or death or subject withdraws informed consent;If the drug has been discontinued or the tumor has progressed, and there are no intolerable side effects, the drug can be continued according to the judgment of the researchers and the will of the subjects. Drug safety was evaluated before each cycle.The first efficacy was evaluated after 2 cycles.The efficacy was then evaluated every 2 cycles.

Being tested
Sintilimab, Axitinib
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.

  • SintilimabDrug

    Also called Tyvyt, IBI 308

    PD-1 inhibitor，Sintilimab 200mg IV, every 3 weeks.

  • AxitinibDrug

    Also called Inlyta

    Tyrosine kinase inhibitor，licensed for use in treatment of renal cell carcinoma. Oral treatment Axitinib given 5 mg PO BID.

Study groups in NCT04958473
Study groupRoleWhat they receive
Patients with advanced RCCExperimentalPatients with a diagnosis of kidney cancer (renal cell carcinoma, advanced or metastatic, previously treated or untreated)
Receives: Drug: Sintilimab; Drug: Axitinib

What is being measured

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

  1. Overall response rate (ORR)

    To be assessed by RECIST 1.1

    Measured: Up to 12 months

Secondary outcomes (4)

  1. Progression free survival (PFS)

    Progression Free Survival (PFS) is the time from randomization to date of first documentation of objective progression of disease assessed by BICR (by RECIST version 1.1) or death due to any cause.

    Measured: From randomization up to 3 years.

  2. Overall Survival (OS)

    OS is the time from date of randomization to date of death due to any cause.

    Measured: Every 3 months up to 3 years.

  3. Disease Control Rate (DCR)

    DC is defined as complete response (CR), partial response (PR), or stable disease (SD) according to the RECIST v.1.1 recorded from randomization until disease progression assessed by BICR or death due to any cause.

    Measured: Every 6 weeks up to 18 months from patient enrollment in the study, then every 12 weeks up to 3 years from randomization

  4. Incidence of treatment-related adverse events

    To be assessed by CTCAE v4.03.

    Measured: Up to 3 years.

Timeline

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

  1. First posted12 Jul 2021
  2. Study start1 Aug 2021 (estimated)
  3. Primary completion1 Aug 2022 (estimated)
  4. Study completion1 Aug 2025 (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
NCT04958473
Sponsor's protocol ID
SAARCC
Acronym
SAARCC
Status last verified
Jul 2021
First submitted
23 Jun 2021
Last updated
12 Jul 2021
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 Sintilimab and Axitinib in people with Renal Cell Carcinoma and Clear Cell Renal Cell Carcinoma, 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 8 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 12 Jul 2021. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact BIN HUO, MD (+86 22 88326610, huobin_doctor@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (ORR) (time frame: Up to 12 months). 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 NCT04958473.

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 12 Jul 2021; AzTrials last refreshed its copy on 7 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in