Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-01-01 @ 8:39 AM
Study NCT ID:
NCT06584435
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-19
First Post:
2024-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Toripalimab in Adjuvant Therapy After Resection of High-risk Renal Cancer
Sponsor:
Tianjin Medical University Second Hospital
Organization:
Study Overview
Official Title:
A Single-arm Study of Toripalimab in Adjuvant Therapy After Resection of High-risk Renal Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TUORA
Brief Summary:
The goal of this clinical trial is to learn if the drug toripalimab (an anti-PD-1 antibody) works to prevent cancer recurrence in patients with high-risk renal cell carcinoma after they have had surgery to remove the kidney (nephrectomy). The study will also learn about the safety of toripalimab in this setting.The main questions the study aims to answer are:
1. Does treatment with toripalimab after nephrectomy increase the time patients live without their cancer returning (disease-free survival) compared to what would be expected without this treatment?
2. What medical problems (side effects) do participants have when receiving toripalimab? This is a single-arm study, meaning all participants in the trial will receive the study drug, toripalimab.. Researchers will monitor participants over time to see if the outcomes with toripalizumab are better than what is historically known for similar patients who only had surgery.
Participants in this study will:
1. Receive toripalimab by intravenous (IV) infusion once every 3 weeks for up to about one year ( 17 doses).
2. Visit the clinic regularly for check-ups, which will include:
Imaging scans (like CT or MRI) of the chest, abdomen, and pelvis every 12 weeks to check for cancer recurrence.
Blood and urine tests to monitor safety. Questionnaires about their quality of life and symptoms. Be followed for a long period after treatment ends to track overall survival and long-term health.
1. Does treatment with toripalimab after nephrectomy increase the time patients live without their cancer returning (disease-free survival) compared to what would be expected without this treatment?
2. What medical problems (side effects) do participants have when receiving toripalimab? This is a single-arm study, meaning all participants in the trial will receive the study drug, toripalimab.. Researchers will monitor participants over time to see if the outcomes with toripalizumab are better than what is historically known for similar patients who only had surgery.
Participants in this study will:
1. Receive toripalimab by intravenous (IV) infusion once every 3 weeks for up to about one year ( 17 doses).
2. Visit the clinic regularly for check-ups, which will include:
Imaging scans (like CT or MRI) of the chest, abdomen, and pelvis every 12 weeks to check for cancer recurrence.
Blood and urine tests to monitor safety. Questionnaires about their quality of life and symptoms. Be followed for a long period after treatment ends to track overall survival and long-term health.
Detailed Description:
1. Study Background and Rationale Renal cell carcinoma (RCC) carries a substantial risk of recurrence post-nephrectomy, particularly in patients with intermediate-high risk, high risk, or M1 no evidence of disease (NED) status following metastasectomy. The phase III KEYNOTE-564 clinical trial demonstrated that adjuvant therapy with pembrolizumab, an anti-PD-1 antibody, significantly improved disease-free survival (DFS) compared to placebo in this patient population, establishing a new therapeutic standard. Building upon this landmark finding, the present study aims to investigate the efficacy and safety of toripalimab, another anti-PD-1 monoclonal antibody, within a similar clinical context. This single-arm, phase II trial seeks to evaluate whether toripalimab can provide comparable clinical benefits, including reduced recurrence risk and improved survival outcomes, for patients with high-risk RCC following complete surgical resection, while thoroughly assessing its safety profile.
2. Study Objectives
Primary Objectives:
To evaluate the efficacy of adjuvant toripalimab as measured by investigator-assessed Disease-Free Survival (DFS) and Overall Survival (OS).
Secondary Objectives:
To assess the safety and tolerability profile of adjuvant toripalimab and patient-reported outcomes (PROs) using quality of life questionnaires..
3. Trial Design and Methodology This is a single-center, prospective, single-arm, Phase II clinical trial. The design leverages the positive signal observed in the KEYNOTE-564 trial to explore the potential of a similar immunotherapeutic agent, toripalimab, in a real-world setting at a major academic center. The study will enroll patients who have undergone nephrectomy and are within the 4 to 12-week postoperative window. Treatment involves intravenous administration of toripalimab at a fixed dose of 240 mg every three weeks, for a planned treatment duration of approximately one year (17 cycles), mirroring the treatment schedule found effective in the precedent trial. Treatment will continue until disease recurrence, unacceptable toxicity, or other protocol-defined discontinuation criteria are met. The single-arm design is chosen to efficiently characterize the activity and safety of toripalimab in this specific adjuvant setting, with outcomes referenced against historical controls and the results of prior pivotal studies.
4. Study Procedures and Assessments
The assessment schedule is structured to closely monitor for efficacy and safety signals, consistent with the standards set by recent practice-changing trials. Key procedures include:
Screening Period (Within 4 weeks prior to treatment initiation):
* Informed consent process.
* Confirmation of diagnosis and high-risk status via central pathology review .
* Tumor imaging via CT or MRI of the chest, abdomen, and pelvis to confirm no evidence of disease post-surgery.
* Collection of archival tumor tissue from nephrectomy/metastasectomy.
* Physical examination, vital signs, ECOG performance status assessment.
* Clinical laboratory tests: hematology, serum chemistry, thyroid function, coagulation profile, urinalysis.
* Viral serology testing (HBV, HCV, HIV).
* Pregnancy test for women of childbearing potential (WOCBP).
* Baseline quality of life assessments (EORTC QLQ-C30 and FKSI-15).
Treatment Period (Each cycle is 3 weeks):
* Pre-dose assessments (Day 1 of each cycle): Vital signs, directed physical exam, assessment of adverse events (AEs) and concomitant medications.
* Toripalimab administration: IV infusion on Day 1 of each cycle.
* Laboratory tests: Hematology and serum chemistry at every cycle; urinalysis and thyroid function tests periodically as specified in the protocol.
* Tumor imaging: CT/MRI scans of chest, abdomen, and pelvis will be performed every 12 weeks (± 7 days) from the date of treatment to assess for disease recurrence.
* Quality of Life (QoL) assessments: EORTC QLQ-C30 and FKSI-15 questionnaires will be administered at predefined cycles and at the end of treatment.
Post-Treatment Follow-up Period:
* Safety Follow-up Visit: Occurs 30 days (± 7 days) after the last dose of toripalimab for ongoing AE monitoring.
* Efficacy Follow-up: After treatment discontinuation (without disease recurrence), patients will continue tumor imaging assessments every 12 weeks (Year 1-3), then every 24 weeks (Years 4+) until disease recurrence, start of new anticancer therapy, or study end.
* Survival Follow-up: Overall survival status will be assessed via telephone or clinic visit every 12 weeks (± 7 days) until death, withdrawal of consent, or the end of the study.
5. Endpoints The endpoints are selected to align with the established efficacy parameters in adjuvant RCC immunotherapy trials, facilitating a meaningful evaluation of toripalimab's benefit-risk profile.
Primary Endpoint:
* Disease-Free Survival (DFS) , defined as the time from randomization to the first documented local or distant recurrence or death from any cause.
* Overall Survival (OS): Defined as the time from randomization to death from any cause.
Secondary Endpoints: Include incidence and severity of adverse events (AEs/SAEs) graded by CTCAE v5.0, and changes from baseline in PRO scores.
6. Statistical Considerations The sample size is planned to be 40-100 participants. The analysis will be primarily descriptive for this single-arm study. Efficacy analyses (DFS, OS) will be performed on the Full Analysis Set (FAS) using Kaplan-Meier methodology. Safety analyses will be conducted on the Safety Set (SS). The results will be contextualized with reference to existing data from the adjuvant RCC treatment landscape, including findings from the KEYNOTE-564 trial.
2. Study Objectives
Primary Objectives:
To evaluate the efficacy of adjuvant toripalimab as measured by investigator-assessed Disease-Free Survival (DFS) and Overall Survival (OS).
Secondary Objectives:
To assess the safety and tolerability profile of adjuvant toripalimab and patient-reported outcomes (PROs) using quality of life questionnaires..
3. Trial Design and Methodology This is a single-center, prospective, single-arm, Phase II clinical trial. The design leverages the positive signal observed in the KEYNOTE-564 trial to explore the potential of a similar immunotherapeutic agent, toripalimab, in a real-world setting at a major academic center. The study will enroll patients who have undergone nephrectomy and are within the 4 to 12-week postoperative window. Treatment involves intravenous administration of toripalimab at a fixed dose of 240 mg every three weeks, for a planned treatment duration of approximately one year (17 cycles), mirroring the treatment schedule found effective in the precedent trial. Treatment will continue until disease recurrence, unacceptable toxicity, or other protocol-defined discontinuation criteria are met. The single-arm design is chosen to efficiently characterize the activity and safety of toripalimab in this specific adjuvant setting, with outcomes referenced against historical controls and the results of prior pivotal studies.
4. Study Procedures and Assessments
The assessment schedule is structured to closely monitor for efficacy and safety signals, consistent with the standards set by recent practice-changing trials. Key procedures include:
Screening Period (Within 4 weeks prior to treatment initiation):
* Informed consent process.
* Confirmation of diagnosis and high-risk status via central pathology review .
* Tumor imaging via CT or MRI of the chest, abdomen, and pelvis to confirm no evidence of disease post-surgery.
* Collection of archival tumor tissue from nephrectomy/metastasectomy.
* Physical examination, vital signs, ECOG performance status assessment.
* Clinical laboratory tests: hematology, serum chemistry, thyroid function, coagulation profile, urinalysis.
* Viral serology testing (HBV, HCV, HIV).
* Pregnancy test for women of childbearing potential (WOCBP).
* Baseline quality of life assessments (EORTC QLQ-C30 and FKSI-15).
Treatment Period (Each cycle is 3 weeks):
* Pre-dose assessments (Day 1 of each cycle): Vital signs, directed physical exam, assessment of adverse events (AEs) and concomitant medications.
* Toripalimab administration: IV infusion on Day 1 of each cycle.
* Laboratory tests: Hematology and serum chemistry at every cycle; urinalysis and thyroid function tests periodically as specified in the protocol.
* Tumor imaging: CT/MRI scans of chest, abdomen, and pelvis will be performed every 12 weeks (± 7 days) from the date of treatment to assess for disease recurrence.
* Quality of Life (QoL) assessments: EORTC QLQ-C30 and FKSI-15 questionnaires will be administered at predefined cycles and at the end of treatment.
Post-Treatment Follow-up Period:
* Safety Follow-up Visit: Occurs 30 days (± 7 days) after the last dose of toripalimab for ongoing AE monitoring.
* Efficacy Follow-up: After treatment discontinuation (without disease recurrence), patients will continue tumor imaging assessments every 12 weeks (Year 1-3), then every 24 weeks (Years 4+) until disease recurrence, start of new anticancer therapy, or study end.
* Survival Follow-up: Overall survival status will be assessed via telephone or clinic visit every 12 weeks (± 7 days) until death, withdrawal of consent, or the end of the study.
5. Endpoints The endpoints are selected to align with the established efficacy parameters in adjuvant RCC immunotherapy trials, facilitating a meaningful evaluation of toripalimab's benefit-risk profile.
Primary Endpoint:
* Disease-Free Survival (DFS) , defined as the time from randomization to the first documented local or distant recurrence or death from any cause.
* Overall Survival (OS): Defined as the time from randomization to death from any cause.
Secondary Endpoints: Include incidence and severity of adverse events (AEs/SAEs) graded by CTCAE v5.0, and changes from baseline in PRO scores.
6. Statistical Considerations The sample size is planned to be 40-100 participants. The analysis will be primarily descriptive for this single-arm study. Efficacy analyses (DFS, OS) will be performed on the Full Analysis Set (FAS) using Kaplan-Meier methodology. Safety analyses will be conducted on the Safety Set (SS). The results will be contextualized with reference to existing data from the adjuvant RCC treatment landscape, including findings from the KEYNOTE-564 trial.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: