A Prospective, Multicenter, Single-arm Clinical Study of the Efficacy and Safety of Toripalimab in Combination With Axitinib for Postoperative Adjuvant Therapy for Non-clear Renal Cell Carcinoma With High-risk Recurrence Factors
Overview
- Phase
- Phase 2
- Intervention
- Toripalimab
- Conditions
- Non-clear Renal Cell Carcinoma
- Sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- DFS
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
The goal of this prospective, multicenter, single-arm clinical study is to evaluate the efficacy and safety of toripalimab in combination with axitinib for postoperative adjuvant therapy for non-clear renal cell carcinoma with high-risk recurrence factors.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18-75 years old
- •Participants with histologically confirmed non-clear renal cell carcinoma except clear cell RCC, chromophobe RCC and eosinophilic RCC, and must meet any of the following conditions:
- •histologically confirmed Papillary RCC, pT≥T1b and ISUP/WHO ≥3, N (any), M0;
- •Collecting duct carcinoma, SMARCB1-deficient renal medullary carcinoma, fumarate hydratase deficiency renal cell carcinoma (FH-RCC), pT (any), ISUP/WHO (any), N (any), M
- •Non-clear renal cell carcinoma except Organizational Credits Type a and b, including but not limited to TFE3/TFEB translocated RCC or unclassified RCC, pT (any), ISUP/WHO ≥ grade 3, N (any), M0;
- •Patients who have completely resected the primary tumor (partial or radical nephrectomy), and M1 NED patients who have completely resected solid, isolated soft tissue metastases.
- •Patients who have completely removed the renal tumor. The nephrectomy must be performed ≥ 3 weeks but ≤ 12 weeks before randomization. Partial nephrectomy and renal tumor enucleation are permitted;
- •Patients must have no clinical or radiographic evidence of macroscopic residual lesions or distant metastasis (M0) after surgery. M1 participants must have no evidence of disease (M1 NED);
- •ECOG performance status 0-1 ;
- •Patients must have not received systemic therapy for renal tumors;
Exclusion Criteria
- •Clear cell RCC, chromophobe RCC and eosinophilic RCC;
- •Previous 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.)
- •Previous drug therapy targeting VEGF, VEGFR, or mTOR;
- •Have participated in or are currently participating in an investigational drug trial within 4 weeks; major surgery performed within 4 weeks prior to randomization;
- •Receive traditional Chinese medicines or proprietary Chinese medicine, adrenocortical hormone or other immunosuppressant systemic therapy within 2 weeks before enrollment; People who \> 10 mg of prednisone or equivalent inhalers daily but have no active autoimmune disease may participate in this study;
- •Toxicity has not been relieved after previous antineoplastic therapy; Irreversible toxicities (e.g., hearing loss) that are reasonably expected not to be aggravated by the study drug may participate in this study;
- •Other malignancies that have progressed or require treatment in 5 years (excluding adequately treated basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, superficial bladder cancer, breast, cervix, or prostate carcinoma in situ);
- •History of central nervous system (CNS) metastases or CNS metastases on baseline imaging (MRI or CT) within 30 days prior to the first trial administration;
- •Hypertension that cannot be controlled by medications (blood pressure 150/100 mmHg despite optimal medical therapy)
- •Evidence of following cardiovascular disease within 6 months:
Arms & Interventions
study group
Drug: Toripalimab 240mg, intravenously every 3 weeks Drug: Axitinib 5 mg orraly twice daily
Intervention: Toripalimab
study group
Drug: Toripalimab 240mg, intravenously every 3 weeks Drug: Axitinib 5 mg orraly twice daily
Intervention: Axitinib
Outcomes
Primary Outcomes
DFS
Time Frame: 2 years
DFS is defined as time interval from the date of randomization to first date of recurrence/relapse (distant or local recurrence of \[RCC\] or occurrence of a secondary malignancy {occurrence of a second primary cancer other than RCC} or death). For participants with no DFS event, DFS was censored at date of last scan prior to time of analyses. Participants alive who did not have post-baseline disease assessments, DFS was censored at randomization. Participants who received further anti-tumor therapy prior to recurrence or occurrence of a secondary malignancy or death, DFS was censored on date of last scan prior to taking anti-tumor medication. Participants who missed 2 or more consecutive tumor scans immediately followed by an event were censored at date of last objective tumor assessment prior to missing/not readable scan.
Secondary Outcomes
- DRSS(3 years)
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(3 years)
- OS(3 years)