Neoadjuvant Therapy of Non-metastatic Locally Advanced Renal Cell CarcinomaPhase 2NCT04118855
Toripalimab Combined With Axitinib as Neoadjuvant Therapy in Patients With Non-metastatic Locally Advanced Nonmetastatic Clear Cell Renal Cell Carcinoma
A Phase 2 study testing Toripalimab and Axitinib in people with Neoadjuvant Therapy of Non-metastatic Locally Advanced Renal Cell Carcinoma, run by RenJi Hospital at 1 site in China.
Trial summary
This study is design to prospectively investigate the safety and efficacy of Toripalimab combined with Axitinib in downsizing tumors in patients with nonmetastatic biopsy-proven clear cell renal cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neoadjuvant Therapy of Non-metastatic Locally Advanced Renal Cell Carcinoma
- What is being tested?
- Toripalimab and Axitinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2020to 31 Mar 2023
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-metastatic biopsy-proven clear cell renal cell carcinoma (T2-T3N0-1M0)
- Schedule to undergo either partial or radical nephrectomy as part of treatment plan
- ECOG performance status of 0 or 1
- Adequate organ and marrow function defined by study-specified laboratory tests
- Agree to comply with scheduled visits, treatment plans, lab tests and other study procedures
- Do not have any other cancers in the 5 yr preceding diagnosis of their renal cancer
Who cannot join
- Patients who have received other systems for anti-tumor treatment
- Patients who have previously received targeted or immunotherapy
- Need for urgent or emergent nephrectomy to relieve symptoms
- Current use of immunosuppressive agents
- Pregnant or breastfeeding women
- History of autoimmune disease or syndrome
Trial locations and contacts
1 site in 1 country.
China1 site
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, 200127
About this study
Official title: Phase II Study of Toripalimab Combined With Axitinib as Neoadjuvant Therapy in Patients With Non-metastatic Locally Advanced Nonmetastatic Clear Cell Renal Cell Carcinoma
This study is design to prospectively investigate the safety and efficacy of Toripalimab combined with Axitinib in downsizing tumors in patients with nonmetastatic biopsy-proven clear cell renal cell carcinoma. Toripalimab is new antibody that may help activate the immune system by blocking the function of an inhibitory molecule, Programmed cell death-1 (PD-1). This is a single-institution, single-arm phase 2 clinical trial.
Read the detailed description
This study is design to prospectively investigate the safety and efficacy of Toripalimab combined with Axitinib in downsizing tumors in patients with nonmetastatic biopsy-proven clear cell renal cell carcinoma. Toripalimab is new antibody that may help activate the immune system by blocking the function of an inhibitory molecule, Programmed cell death-1 (PD-1). This is a single-institution, single-arm phase 2 clinical trial. Patients will receive axitinib 5 mg bid combined with Toripalimab 3mg/KG q3w for up to 12 wk. Patients then will receive partial or radical nephrectomy after neoadjuvant therapy.
- Being tested
- Toripalimab, Axitinib
- Keywords
- neoadjuvant therapy, Toripalimab, axitinib, nephrectomy, partial nephrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToripalimabDrug
Also called anti-PD-1 monoclonal antibody
240mg, IV (in the vein) on on day 1 of 3-week, 6-week and 9-week for a total of 3 doses prior to partial nephrectomy or radical nephrectomy
AxitinibDrug
5 mg by mouth twice each day for 12 weeks prior to nephrectomy
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant arm | Experimental | Patients will receive axitinib 5 mg bid combined with Toripalimab 3mg/KG q3w for up to 12 wk. Receives: Drug: Toripalimab; Drug: Axitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Tumor Response Rate
Number of patients achieving a complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors
Measured: 3 month
Secondary outcomes (4)
Safety assessed by adverse events
Safety as assessed by number of participants experiencing adverse events
Measured: through study completion, an average of 4 months
Perioperative complication rate
Perioperativecomplications judged by Clavien-Dindo classification
Measured: from perioperative to 90 days after surgery
Quality of Life questionnaire
Quality of Life as assessed by the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI) -15 questionnaire
Measured: Baseline, 3 weeks, 12 weeks and after surgery
Tumor complexity changing by total R.E.N.A.L. score
R.E.N.A.L. Nephrometry Score) to quantify the anatomical characteristics of renal R.E.N.A.L. score consists of 5 anatomical features, and sum them up.
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start1 Mar 2020
- Primary completion28 Feb 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neoadjuvant Therapy of Non-metastatic Locally Advanced Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- 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
- Model description
- Before surgery, patients will receive axitinib 5 mg bid combined with Toripalimab 3mg/KG q3w for up to 12 wk.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04118855
- Sponsor's protocol ID
- Neo-RCC
- Status last verified
- Apr 2023
- First submitted
- 4 Oct 2019
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Huang J, Wang Y, Xu F, Wang Z, Wu G, Kong W, Cheoklong NG, Tricard T, Wu X, Zhai W, Zhang W, Zhang J, Zhang D, Chen S, Lian Y, Chen Y, Zhang J, Huang Y, Xue W. Neoadjuvant toripalimab combined with axitinib in patients with locally advanced clear cell renal cell carcinoma: a single-arm, phase II trial. J Immunother Cancer. 2024 Jun 11;12(6):e008475. doi: 10.1136/jitc-2023-008475.
PubMed 38862251
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Toripalimab Combined With Axitinib as Neoadjuvant Therapy in Patients With Non-metastatic Locally Advanced Nonmetastatic Clear Cell Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT04118855
- Acronym / sponsor ID
- Neo-RCC
- Keywords
- neoadjuvant therapy, Toripalimab, axitinib, nephrectomy, partial nephrectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 8 Oct 2019 (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 study is design to prospectively investigate the safety and efficacy of Toripalimab combined with Axitinib in downsizing tumors in patients with nonmetastatic biopsy-proven clear cell renal cell carcinoma. Toripalimab is new antibody that may help activate the immune system by blocking the function of an inhibitory molecule, Programmed cell death-1 (PD-1). This is a single-institution, single-arm phase 2 clinical trial.
Detailed description
This study is design to prospectively investigate the safety and efficacy of Toripalimab combined with Axitinib in downsizing tumors in patients with nonmetastatic biopsy-proven clear cell renal cell carcinoma. Toripalimab is new antibody that may help activate the immune system by blocking the function of an inhibitory molecule, Programmed cell death-1 (PD-1). This is a single-institution, single-arm phase 2 clinical trial. Patients will receive axitinib 5 mg bid combined with Toripalimab 3mg/KG q3w for up to 12 wk. Patients then will receive partial or radical nephrectomy after neoadjuvant therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Before surgery, patients will receive axitinib 5 mg bid combined with Toripalimab 3mg/KG q3w for up to 12 wk.
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant arm | Experimental | Drug: Toripalimab, Drug: AxitinibPatients will receive axitinib 5 mg bid combined with Toripalimab 3mg/KG q3w for up to 12 wk. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Non-metastatic biopsy-proven clear cell renal cell carcinoma (T2-T3N0-1M0)
- Schedule to undergo either partial or radical nephrectomy as part of treatment plan
- ECOG performance status of 0 or 1
- Adequate organ and marrow function defined by study-specified laboratory tests
- Agree to comply with scheduled visits, treatment plans, lab tests and other study procedures
Key exclusion criteria (6 listed)
- Patients who have received other systems for anti-tumor treatment
- Patients who have previously received targeted or immunotherapy
- Need for urgent or emergent nephrectomy to relieve symptoms
- Current use of immunosuppressive agents
- Pregnant or breastfeeding women
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 |
|---|---|---|
| ToripalimabAlso: anti-PD-1 monoclonal antibody240mg, IV (in the vein) on on day 1 of 3-week, 6-week and 9-week for a total of 3 doses prior to partial nephrectomy or radical nephrectomy | Drug | Neoadjuvant arm |
| Axitinib5 mg by mouth twice each day for 12 weeks prior to nephrectomy | Drug | Neoadjuvant arm |
Primary outcome
Objective Tumor Response Rate
Time frame: 3 month
Number of patients achieving a complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors
4 secondary outcomes
Safety assessed by adverse events
Time frame: through study completion, an average of 4 months
Perioperative complication rate
Time frame: from perioperative to 90 days after surgery
Quality of Life questionnaire
Time frame: Baseline, 3 weeks, 12 weeks and after surgery
Tumor complexity changing by total R.E.N.A.L. score
Time frame: Baseline, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Derived from this study: PubMed 38862251Huang J, Wang Y, Xu F, Wang Z, Wu G, Kong W, Cheoklong NG, Tricard T, Wu X, Zhai W, Zhang W, Zhang J, Zhang D, Chen S, Lian Y, Chen Y, Zhang J, Huang Y, Xue W. Neoadjuvant toripalimab combined with axitinib in patients with locally advanced clear cell renal cell carcinoma: a single-arm, phase II trial. J Immunother Cancer. 2024 Jun 11;12(6):e008475. doi: 10.1136/jitc-2023-008475.
Related trials for Neoadjuvant Therapy of Non-metastatic Locally Advanced Renal Cell Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2
Neoadjuvant Zanzalintinib Plus Nivolumab in Patients With Locally Advanced and/or Inoperable Clear Cell Renal Cell Carcinoma With or Without Non-measurable Metastasis
Locally Advanced Renal Cell Carcinoma
Active, not recruitingPhase 2
Neoadjuvant Cabozantinib in Treating Patients With Locally Advanced Kidney Cancer
Clear Cell Renal Cell Carcinoma, Renal Cell Carcinoma
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Toripalimab and Axitinib in people with Neoadjuvant Therapy of Non-metastatic Locally Advanced Renal Cell Carcinoma, run by RenJi 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 4 Apr 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Tumor Response Rate (time frame: 3 month). 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 NCT04118855, 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 4 Apr 2023.