NCT04146831

Sintilimab in FH-deficient Renal Cell Carcinoma

Phase II Study of Sintilimab, a PD-1 Inhibitor, as Second-line Treatment in FH-deficient Renal Cell Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm phase II clinical trial to evaluate the initial efficacy and safety of Sintilimab, a PD-1 Inhibitor, as Second-line Treatment in FH-deficient Renal Cell Carcinoma.

Detailed description

Fumarate hydratase-deficient renal cell carcinoma (FH-deficient RCC) is a rare subtype of RCC characterized by germline/somatic mutation of the fumarate hydratase (FH) gene, and is an extremely aggressive tumor, with a propensity to disseminate early even in the setting of a small primary tumor. Loss-of-function mutation of FH results in the accumulation of fumarate, impairment of oxidative phosphorylation, alteration of the metabolic state, and stabilization of hypoxia-inducible factor (HIF)-1α, thus activating angiogenic and oxidative stress response pathways. Unlike the robust response of clear cell RCC (ccRCC) to antiangiogenic agents, blocking the antiangiogenic pathway does not lead to better outcomes in FH-deficient RCC. Anti-mTOR agents are also ineffective. Although the National Comprehensive Cancer Network (NCCN) guideline recommends the combination of bevacizumab plus erlotinib or everolimus for metastatic FH-deficient RCC, high-level evidence for standardized systematic therapy remains scarce. In the present study, the investigators plan to assess the efficacy and safety of immunotherapy with Sintilimab as second-line treatment in FH-deficient RCC, and to explore potential biomarkers related to the treatment efficacy by means of detection, including but not limited to the next-generation sequencing, flow cytometry, etc.

Conditions

• Renal Cell Carcinoma
• FH-deficient
• Sintilimab

Interventions

Type	Name	Description
DRUG	Sintilimab	Sintilimab: intravenous, 200mg, every 3 week. Course of treatment: Stop the treatment until clinical or radiographic progression occurs.

Timeline

• Start date: 2020-06-01
• Primary completion: 2022-06-01
• Completion: 2023-04-01
• First posted: 2019-10-31
• Last updated: 2020-05-12