Neoadjuvant TherapyPhase 2NCT05172440
A Study on the Safety and Effectiveness of Tislelizumab Combined With Axitinib for Neoadjuvant Treatment of ccRCC
A Phase 2 study testing tislelizumab combined with axitinib in people with Neoadjuvant Therapy, run by Hongqian Guo at 1 site in China.
Trial summary
This trial is a single-center clinical trial to evaluate the tumor shrinkage and safety of tislelizumab combined with axitinib in Neoadjuvant therapy of T2-T3N0M0 renal clear cell carcinoma Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neoadjuvant Therapy
- What is being tested?
- tislelizumab combined with axitinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 9 Dec 2021to 1 Oct 2024
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years old
- Imaging is consistent with T2-T3N0M0 renal cell carcinoma
- Needle pathological biopsy is consistent with renal clear cell carcinoma
- The subject intends to undergo radical nephrectomy or partial nephrectomy or renal tumor enucleation
- ECOG 0-1 points
- Normal hematopoiesis and organ function
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- Hematopoietic function (no blood transfusion or blood products, no use of hematopoietic stimulating factors or other drugs to correct blood cells within 2 weeks before the first trial medication):
- Absolute neutrophil count (ANC) ≥1.5×109/L; Platelet ≥100×109/L; Hemoglobin ≥9.0g/dL or ≥5.6mmol/L.
- Kidney function:
- Serum creatinine ≤ 1.5 times ULN, or serum creatinine> 1.5×ULN, the creatinine clearance rate is 60 mL/min; liver function: Total bilirubin≤1.5×ULN or total bilirubin>1.5×ULN but direct bilirubin is normal; AST and ALT≤2.5×ULN;
- Coagulation:
- International normalized ratio (INR) or prothrombin time (PT)≤1.5×ULN, and the activated part Thromboplastin time (aPTT)≤1.5×ULN; Left ventricular ejection fraction (LVEF) ≥50%
- Able to sign informed consent
- During the entire study period and within 3 months after the last administration, the subjects and their spouses are willing to use efficient contraceptive measures and not to donate sperm;
- Understand and conduct visits, treatments, laboratory tests, and other research procedures as planned.
Who cannot join
- Previously received anti-tumor immunotherapy, including but not limited to cytokines (IL-2, IFN-α, etc.) and antibody drugs (anti-PD-1, PD-L1 or CTLA-4 antibodies, etc.);
- Have previously received drug treatments targeting VEGF, VEGFR or mTOR, including but not limited to sunitinib, axitinib, sorafenib, pezopanib, cabotinib, lenvatinib, Bevacizumab or Iverolimus, etc.;
- Participated in or currently participating in an experimental drug trial within 4 weeks before the first trial drug administration, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study; major surgery within 4 weeks before the first trial drug administration (Judgment by the investigator) or in the recovery period of surgery.
- Receive Chinese medicine or Chinese patent medicine preparations with anti-tumor indications within 2 weeks before the administration of the first trial. Adrenal cortex hormones (>10 mg prednisone or equivalent drugs per day) or other immunosuppressive system treatments are required within 2 weeks before the first trial administration; those with >10 mg prednisone or equivalent drugs per day Inhalers, but those without active autoimmune diseases can participate in this study;
- The toxicity has not been relieved after previous anti-tumor treatment, that is, it has not subsided to baseline, NCI-CTCAE 5.0 level 0~1 (except for hair loss), or the level specified in the inclusion/exclusion criteria. Irreversible toxicity (such as hearing loss) that is reasonably expected to not be aggravated by the study drug can participate in this study;
- There are other malignant tumors that have progressed or need to be treated in the 5 years before enrollment (excluding basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of breast, cervix or prostate);
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- There is a history of central nervous system (CNS) metastasis or the baseline imaging (MRI or CT) examination within 30 days before the first trial administration shows CNS metastasis;
- Hypertension with poor control (systolic blood pressure ≥150mmHg and/or diastolic blood pressure ≥100mmHg) with a single drug;
- The following cardiovascular events occurred in the 6 months before enrollment:
- Myocardial infarction
- Unstable angina
- Cardiovascular angioplasty or stent implantation
- Coronary artery/peripheral artery bypass grafting
- Grade III or IV congestive heart failure specified by the New York Heart Association
- Cerebrovascular accident or transient ischemic attack
- QT interval (QTc) ≥480 msec corrected by heart rate (Bazett's formula);
- A history of active bleeding or other severe bleeding within 30 days before enrollment, and a history of hemoptysis within 6 weeks before randomization;
- Deep vein thrombosis or pulmonary embolism occurred within 6 months before enrollment;
- Clinically significant gastrointestinal (GI) abnormalities, including:
- Malabsorption, total gastrectomy or any situation that may affect the absorption of oral drugs;
- Active ulcers that have been treated within the past 6 months;
- Active gastrointestinal bleeding (such as hematemesis, hematochezia or melena) within the past 3 months, and there is no evidence of recovery from endoscopic or colonoscopy;
- Suspected bleeding gastrointestinal metastatic lesions, inflammatory bowel disease, ulcerative colitis, gastrointestinal perforation or other gastrointestinal diseases that increase the risk of perforation;
- A history of organ transplantation may require long-term adrenal cortex hormone therapy. Thyroid, adrenal or pituitary hypofunction that can be controlled only by hormone replacement therapy, type I diabetes, psoriasis or vitiligo that does not require systemic treatment, etc., can participate in this study;
- Past or current (non-infectious) pneumonia/interstitial lung disease that requires adrenal cortex hormone therapy;
- There are active infections that require systemic treatment, human immunodeficiency virus (HIV) infection (known HIV antibody positive), active HBV or HCV infection (HBsAg positive, or HBcAb positive but HBsAg negative). Additional DNA quantification tests can participate in this study if the result does not exceed the upper limit of the normal value of the research center laboratory; previous HCV infections have negative HCV RNA test results during the screening period, can participate in this study);
- Live vaccines, including but not limited to mumps, rubella, measles, chickenpox/shingles (chickenpox), yellow fever, rabies, Bacille Calmette-Guerin (BCG) and typhoid vaccines within 30 days before enrollment, excluding inactivated viruses vaccine;
- There is a history of severe drug allergy, including but not limited to antibody drugs and small molecule targeted drugs;
- Known history of mental illness or drug abuse;
- There is an unhealed wound;
- Take it within 7 days before enrollment or expect to take it after enrollment, which is known as a strong CYP3A4/5 inhibitor and CYP3A4/5 inducer (including but not limited to carbamazepine, phenobarbital, phenytoin, rifabutin, Rifampicin and Hypericum perforatum, etc.) or drugs that may cause arrhythmia (including but not limited to terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol and bep) Lee, etc.);
- According to the judgment of the investigator, the subject has any medical history or current evidence of any disease, treatment or laboratory abnormality that may confuse the test results, interfere with the subject's participation in the entire trial, or do not meet the subject's best interest in participating in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Clinical Study on the Safety and Effectiveness of Tislelizumab Combined With Axitinib for Neoadjuvant Treatment of Clear Cell Renal Cell Carcinoma
This trial is a single-center clinical trial to evaluate the tumor shrinkage and safety of tislelizumab combined with axitinib in Neoadjuvant therapy of T2-T3N0M0 renal clear cell carcinoma
Read the detailed description
The goal of the study is to use axitinib combined with tislelizumab in the Neoadjuvant therapy of T2-T3 N0M0 renal clear cell carcinoma to shrink tumors or tumor thrombi, reduce the complexity of surgery, and achieve kidney Partial resection or enucleation of renal tumors instead of kidney Partial resection, or unresectable renal tumors can be changed to resectable and improve the patient's prognosis.
The primary endpoint is the tumor shrinkage effect of tislelizumab combined with axitinib in Neoadjuvant therapy of T2-T3N0M0 renal clear cell carcinoma.
The secondary end point is
- The safety and downgrading rate of tislelizumab combined with axitinib in Neoadjuvant therapy of T2-T3N0M0 renal clear cell carcinoma；
- Two-year disease-free survival (DFS) of tislelizumab combined with axitinib in Neoadjuvant therapy of T2-T3N0M0 renal clear cell carcinoma；
- Explore biomarkers in tumor tissue and blood that may be related to the efficacy of neoadjuvant therapy and the prognosis of subjects;
- Conditions
- Neoadjuvant Therapy
- Being tested
- tislelizumab combined with axitinib
- Keywords
- ccRCC, Neoadjuvant therapy, tislelizumab, axitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tislelizumab combined with axitinibDrug
Subjects received axitinib 5 mg bid, 12 weeks, and tislelizumab 200 mg on the first day of the first week, 4th week, 7th week, and 10th week, and intravenous infusion. With 21 days as a treatment cycle, 4 cycles of treatment, namely 12 weeks. Axitinib was discontinued for 12 weeks after the completion of treatment, and surgery was performed 7 days later.
| Study group | Role | What they receive |
|---|---|---|
| therapy group | Experimental | Subjects received axitinib 5 mg bid, 12 weeks, and tislelizumab 200 mg on the first day of the first week, 4th week, 7th week, and 10th week, and intravenous infusion. With 21 days as a treatment cycle, 4 cycles of treatment, namely 12 weeks. Axitinib was discontinued for 12 weeks after the completion of treatment, and surgery was performed 7 days later. Receives: Drug: tislelizumab combined with axitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate of tislelizumab combined with axitinib in neoadjuvant treatment of T2-T3N0M0 renal clear cell carcinoma
Objective response rate of tislelizumab combined with axitinib in neoadjuvant treatment of T2-T3N0M0 renal clear cell carcinoma
Measured: 7 days before surgery
Secondary outcomes (4)
The safety of tislelizumab combined with axitinib in neoadjuvant treatment of T2-T3N0M0 renal clear cell carcinoma
The safety of tislelizumab combined with axitinib in neoadjuvant treatment of T2-T3N0M0 renal clear cell carcinoma
Measured: Follow-up period
Two-year disease-free survival (DFS) of tislelizumab combined with axitinib in neoadjuvant treatment of T2-T3N0M0 renal clear cell carcinoma
Two-year disease-free survival (DFS) of tislelizumab combined with axitinib in neoadjuvant treatment of T2-T3N0M0 renal clear cell carcinoma
Measured: Three months to 2 years after surgery
Explore biomarkers in tumor tissue and blood that may be related to the efficacy of neoadjuvant therapy and the prognosis of subjects
The test content covers all exon regions of genes related to the prognosis, medication and development of kidney cancer, including homologous recombination repair (HRR) defect signaling pathways, WNT signal pathway , cell cycle pathway , MAPK signal pathway and chromosome remodeling signaling pathways
Measured: Three months to 2 years after surgery
The downgrading rate of tislelizumab combined with axitinib in neoadjuvant treatment of T2-T3N0M0 renal clear cell carcinoma
The downgrading rate of tislelizumab combined with axitinib in neoadjuvant treatment of T2-T3N0M0 renal clear cell carcinoma
Measured: Three months to 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start9 Dec 2021
- Primary completion20 Nov 2023 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoadjuvant TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hongqian Guo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hongqian Guo, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Investigators
- shun zhang, Dr., Principal investigator, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05172440
- Sponsor's protocol ID
- IUNU-RC-101
- Status last verified
- Sep 2021
- First submitted
- 4 Nov 2021
- Last updated
- 29 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Study on the Safety and Effectiveness of Tislelizumab Combined With Axitinib for Neoadjuvant Treatment of Clear Cell Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT05172440
- Acronym / sponsor ID
- IUNU-RC-101
- Conditions
- Neoadjuvant Therapy
- Keywords
- ccRCC, Neoadjuvant therapy, tislelizumab, axitinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hongqian GuoUniversity, hospital or other
- Study start
- 9 Dec 2021 (actual)
- Primary completion
- 20 Nov 2023 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 29 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is a single-center clinical trial to evaluate the tumor shrinkage and safety of tislelizumab combined with axitinib in Neoadjuvant therapy of T2-T3N0M0 renal clear cell carcinoma
Detailed description
The goal of the study is to use axitinib combined with tislelizumab in the Neoadjuvant therapy of T2-T3 N0M0 renal clear cell carcinoma to shrink tumors or tumor thrombi, reduce the complexity of surgery, and achieve kidney Partial resection or enucleation of renal tumors instead of kidney Partial resection, or unresectable renal tumors can be changed to resectable and improve the patient's prognosis.
The primary endpoint is the tumor shrinkage effect of tislelizumab combined with axitinib in Neoadjuvant therapy of T2-T3N0M0 renal clear cell carcinoma.
The secondary end point is
- The safety and downgrading rate of tislelizumab combined with axitinib in Neoadjuvant therapy of T2-T3N0M0 renal clear cell carcinoma；
- Two-year disease-free survival (DFS) of tislelizumab combined with axitinib in Neoadjuvant therapy of T2-T3N0M0 renal clear cell carcinoma；
- Explore biomarkers in tumor tissue and blood that may be related to the efficacy of neoadjuvant therapy and the prognosis of subjects;
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| therapy group | Experimental | Drug: tislelizumab combined with axitinibSubjects received axitinib 5 mg bid, 12 weeks, and tislelizumab 200 mg on the first day of the first week, 4th week, 7th week, and 10th week, and intravenous infusion. With 21 days as a treatment cycle, 4 cycles of treatment, namely 12 weeks. Axitinib was discontinued for 12 weeks after the completion of treatment, and surgery was performed 7 days later. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age 18-75 years old
- Imaging is consistent with T2-T3N0M0 renal cell carcinoma
- Needle pathological biopsy is consistent with renal clear cell carcinoma
- The subject intends to undergo radical nephrectomy or partial nephrectomy or renal tumor enucleation
- ECOG 0-1 points
Key exclusion criteria (32 listed)
- Previously received anti-tumor immunotherapy, including but not limited to cytokines (IL-2, IFN-α, etc.) and antibody drugs (anti-PD-1, PD-L1 or CTLA-4 antibodies, etc.);
- Have previously received drug treatments targeting VEGF, VEGFR or mTOR, including but not limited to sunitinib, axitinib, sorafenib, pezopanib, cabotinib, lenvatinib, Bevacizumab or Iverolimus, etc.;
- Participated in or currently participating in an experimental drug trial within 4 weeks before the first trial drug administration, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study; major surgery within 4 weeks before the first trial drug administration (Judgment by the investigator) or in the recovery period of surgery.
- Receive Chinese medicine or Chinese patent medicine preparations with anti-tumor indications within 2 weeks before the administration of the first trial. Adrenal cortex hormones (>10 mg prednisone or equivalent drugs per day) or other immunosuppressive system treatments are required within 2 weeks before the first trial administration; those with >10 mg prednisone or equivalent drugs per day Inhalers, but those without active autoimmune diseases can participate in this study;
- The toxicity has not been relieved after previous anti-tumor treatment, that is, it has not subsided to baseline, NCI-CTCAE 5.0 level 0~1 (except for hair loss), or the level specified in the inclusion/exclusion criteria. Irreversible toxicity (such as hearing loss) that is reasonably expected to not be aggravated by the study drug can participate in this study;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tislelizumab combined with axitinibSubjects received axitinib 5 mg bid, 12 weeks, and tislelizumab 200 mg on the first day of the first week, 4th week, 7th week, and 10th week, and intravenous infusion. With 21 days as a treatment cycle, 4 cycles of treatment, namely 12 weeks. Axitinib was discontinued for 12 weeks after the completion of treatment, and surgery was performed 7 days later. | Drug | therapy group |
Primary outcome
Objective response rate of tislelizumab combined with axitinib in neoadjuvant treatment of T2-T3N0M0 renal clear cell carcinoma
Time frame: 7 days before surgery
Objective response rate of tislelizumab combined with axitinib in neoadjuvant treatment of T2-T3N0M0 renal clear cell carcinoma
4 secondary outcomes
The safety of tislelizumab combined with axitinib in neoadjuvant treatment of T2-T3N0M0 renal clear cell carcinoma
Time frame: Follow-up period
Two-year disease-free survival (DFS) of tislelizumab combined with axitinib in neoadjuvant treatment of T2-T3N0M0 renal clear cell carcinoma
Time frame: Three months to 2 years after surgery
Explore biomarkers in tumor tissue and blood that may be related to the efficacy of neoadjuvant therapy and the prognosis of subjects
Time frame: Three months to 2 years after surgery
The downgrading rate of tislelizumab combined with axitinib in neoadjuvant treatment of T2-T3N0M0 renal clear cell carcinoma
Time frame: Three months to 2 years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
shun zhang, Dr. principal investigator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing tislelizumab combined with axitinib in people with Neoadjuvant Therapy, run by Hongqian Guo 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 15 inclusion and 32 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 29 Dec 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?
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?
Objective response rate of tislelizumab combined with axitinib in neoadjuvant treatment of T2-T3N0M0 renal clear cell carcinoma (time frame: 7 days before surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Dec 2021.