Fumarate Hydratase Deficient Renal Cell Carcinoma
Conditions
Keywords
PD-1 checkpoint inhibitor, FHRCC
Brief summary
FHRCC is a rare kind of renal cell carcinoma with a morbidity of 1/2000000 per year.Although several combination therapies demonstrated possible efficacy in this population. No standard treatment has been approved. The purpose of this study is to evaluate the efficacy and safety of Lenvatinib in combination with tislelizumab in the first line treatment of patients with locally advanced/metastatic FHRCC.
Interventions
BIOLOGICALTislelizumab
Intravenous infusion
DRUGLenvatinib
Oral tablet
Sponsors
RenJi Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Fully understand and voluntarily sign the informed consent form and agree to receive treatment, examination and follow-up as required by the study protocol; 2. Age ≥ 18, \< 80 years, male or female; 3. ECOG score ≤2; 4. unresectable or recurrent metastatic FH-deficient renal cell carcinoma not previously treated with systemic antitumor therapy, as confirmed by histology. Prior cytokine therapy is allowed; 5. At least 1 measurable tumor lesion according to RECIST 1.1 criteria. The lesion that has received prior radiotherapy and progressed again is allowed as a target lesion; 6. agree to provide blood and urine samples and previous archived or fresh tumor tissue samples. 7. Demonstrates adequate organ function. 8. Female subjects of childbearing potential must have a negative serum pregnancy test result within 7 days prior to the first dose. participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 180 days after the last dose of study drug.
Exclusion criteria
1. Prior treatment with agents targeting VEGF, VEGFR, or mTOR, including but not limited to sunitinib, axitinib, pazopanib, sorafenib, cabozantinib, lenvatinib, bevacizumab, anlotinib, or everolimus; 2. Prior treatment with anti-PD-1, PD-L1 or CTLA-4 antibodies; 3. Participants who are using other investigational agents or who had received investigational drugs \<=4 weeks prior to study treatment start; 4. Received major surgery or is recovering from surgery (as judged by the investigator) within 4 weeks; 5. Received Chinese herbal or proprietary Chinese medicine preparation with an antitumor indication within 2 weeks; 6. Requirement of adrenocorticosteroids (\>10 mg prednisone or equivalent daily) or other immunosuppressive systemic therapy within 2 week; inhalation of \>10 mg prednisone or equivalent daily, but without active autoimmune disease may participate in this study; 7. History of organ transplantation or conditions requiring long-term adrenocorticosteroid or immunosuppressive therapy 8. Hypothyroidism, adrenal or pituitary gland function that can be controlled with hormone replacement therapy, type I diabetes mellitus, psoriasis or vitiligo that do not require systemic therapy may be enrolled in the study; 9. Didn't recover from prior antineoplastic therapy, grade 0 to 1 as defined by NCI-CTCAE 5.0 (except alopecia), or levels specified in the inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Up to approximately 24 months | ORR was determined per RECIST 1.1 and was defined as the percentage of participants in the analysis population who had a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Up to approximately 24 months | PFS was defined as the time from enrollment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. |
| Overall Survival (OS) | Up to approximately 24 months | OS was defined as the time from enrollment to death due to any cause. |
| Disease Control Rate (DCR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Up to approximately 24 months | DCR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions), Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters), or Stable Disease (SD) per RECIST 1.1 for ≥6 months. |
| Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Up to approximately 24 months | DOR was defined as the time from first documented evidence of a Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1 until progressive disease (PD) or death due to any cause, whichever occurred first. |
| Overall Survival (OS) Rate at Month 12 in All Participants | Month 12 | The OS rate was determined for all participants at Month 12 and was defined as the time from enrollment to death due to any cause. |
| Overall Survival (OS) Rate at Month 24 in All Participants | Month 24 | The OS rate was determined for all participants at Month 24 and was defined as the time from enrollment to death due to any cause. |
| Number of Participants Who Experienced an Adverse Event (AE) | Up to approximately 24 months | An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. |
Countries
China
Outcome results
None listed