Toripalimab: Toripalimab is a newly developed recombinant humanized (with a degree of 97%) anti-PD-1 monoclonal antibody (Chinese patent authorization number CN104250302B, PCT patent publication number (WO2014/206107A1)), belonging to the human IgG4/Kappa subtype. A point mutation of proline (S228P) has been introduced at the serine protein site 228 in the IgG4 hinge region to increase antibody stability and reduce possible IgG4 Fab chain substitutions. It can specifically bind to PD-1 and effectively block the interaction between PD-1 and its ligands PD-L1 (i.e. B7-H1) and PD-L2 (i.e. B7-DC), thereby activating cytotoxic T lymphocytes, increasing lymphocyte proliferation, and cytokine secretion, especially IFN - γ. To achieve the goal of using the immune system to kill tumors.
Study summary
This is a prospective cohort study aimed at clarifying the predictive value of MRD for postoperative DFS and OS in high-risk recurrent renal cell carcinoma patients who have undergone radical nephrectomy and received adjuvant treatment with Toripalimab. Further differentiating patients who need adjuvant immunotherapy.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
1. There must be a histological diagnosis of renal cell carcinoma, with or without sarcomatoid features of clear cell components.
2. On the day of signing the informed consent form, both males and females must be at least 18 years old.
3. The participants provide written informed consent for the trial before enrollment.
4. Have high risk or M1 NED renal cell carcinoma as defined by the following pathological tumor-node-metastasis and Fuhrman grading status.
1. High risk RCC
* pT4, Any Gr. N0, M0
* pT Any stage, Any Gr., N+, M0
2. M1 NED RCC (participants who present not only with the primary kidney tumor but also solid, isolated, soft tissue metastases that can be completely resected at the time of nephrectomy)
5. No previous systemic treatment for advanced RCC (except nephrectomy or pyelectomy) has been performed.
6. Radical nephrectomy (and complete resection of metastatic lesions in M1 NED participants) was performed with a negative surgical margin.
7. It must be evaluated by the investigator as tumor-free and verified by imaging such as CT or MRI. No suspicious brain metastases.
8. Have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
9. Non-surgical sterilization or female participants of childbearing potential who are required to use a medically approved contraceptive method (such as an IUD, contraceptive pill or condom) during the study treatment period and for 3 months after the end of the study treatment period; Serum or urine HCG tests must be negative for women of non-surgical sterilization or childbearing age within 7 days prior to study enrollment; And must be non-lactation period; Non-surgical sterilization or male patients of childbearing age who consent to use a medically approved contraceptive method with their spouse during the study treatment period and for 3 months after the end of the study treatment period.
10. Vital organ function meets the following requirements (excluding use of any blood components and cell growth factors within 14 days) : normal bone marrow reserve function; Absolute neutrophil count (ANC)≥1500/µL, Platelets≥100 000/µL, Hemoglobin ≥5.6 mmol/L (9g/dL); Normal renal function or serum creatinine ≤1.5 mg/d and/or creatinine clearance ≥30 mL/min for participants with creatinine levels \>1.5×institutional ULN; Normal liver function or Total bilirubin ≤1.5xULN, or direct bilirubin≤ULN for participants with total bilirubin levels \>1.5×ULN; AST (SGOT) and ALT (SGPT) ≤2.5×ULN; International normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN.
Primary outcome measure(s)
Effect on the disease-free survival in the trial patients. — Imaging (CT, MRI) was evaluated at 12 weeks after the first dose of Toripalimab and every 12 weeks. Until the tumor recurred or could not tolerate the side effects or the drug for 1 year. The sample size was calculated based on the objective response rate reported in the previous literature, and the target assumption was that the recurrence rate was 30% at 2 years and that adjuvant therapy with Toripalimab would prevent 50% of relapses.
Trial sites (1)
Facility
City
Region
Status
Changyi Quan
Tianjin
Tianjin Municipality
Recruiting
More Tianjin Medical University Second Hospital trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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