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NCT05877820
A Study to Evaluate Efficacy and Safety of Lenvatinib Combined With Tislelizumab in Patients With FHRCC
Phase 2 trial testing Tislelizumab in Fumarate Hydratase Deficient Renal Cell Carcinoma in 10 participants. Status unknown.
30 June 2025
Quick facts
| Lead sponsor | RenJi Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 1 June 2023 |
| Primary completion | 30 June 2025 |
| Estimated completion | 31 December 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- Tislelizumab (TISLELIZUMAB) — full drug profile →
- Lenvatinib (LENVATINIB) — full drug profile →
Conditions studied
- Fumarate Hydratase Deficient Renal Cell Carcinoma — all drugs for Fumarate Hydratase Deficient Renal Cell Carcinoma →
Sponsor
RenJi Hospital
Who can join
Adults 18 to 80, any sex, with Fumarate Hydratase Deficient Renal Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
-
Programmed death receptor (PD-)1/PD-ligand (L)1 in urological cancers : the "all-around warrior" in immunotherapy.
Liu Q, Guan Y, Li S. · · 2024 · cited 50× · PMID 39223527 · DOI 10.1186/s12943-024-02095-8 -
Cabozantinib in combination with immune checkpoint inhibitors for renal cell carcinoma: a systematic review and meta-analysis.
Su J, Zhang J, Wu Y, Ni C, et al · · 2024 · cited 3× · PMID 38694912 · DOI 10.3389/fphar.2024.1322473 -
Recent progress in non-clear cell renal cell carcinoma: biology and therapeutic strategies.
Yildirim A, Moses MW, Gerke M, Jani Y, et al · · 2025 · cited 2× · PMID 40535735 · DOI 10.1177/17588359251345722 -
Targeting metabolic and epigenetic reprogramming in metastatic fumarate hydratase-deficient renal cell carcinoma.
Kührer N, Huebner-Resch I, Mayr R, Agaimy A, et al · · 2025 · cited 1× · PMID 40779213 · DOI 10.1007/s10585-025-10368-9 -
Case Report: A patient with metastatic fumarate hydratase-deficient renal cell carcinoma associated with leiomyomatosis: real-world clinical insights on systemic therapy and liver-directed SBRT.
Chong HJ, Murray A, Chong KJ. · · 2026 · PMID 41789002 · DOI 10.3389/fonc.2026.1729830 -
Tislelizumab plus lenvatinib as the first-line therapy in patients with advanced fumarate hydratase-deficient renal cell carcinoma: a single-arm, single-centre, phase 2 trial and metabolic biomarker analysis
Zhang J, Kong W, Xu Y, Liu G, et al · · 2026 · DOI 10.21203/rs.3.rs-8771803/v1 -
Complete response to fifth-line anti-PD-1 rechallenge in fumarate hydratase-mutated papillary renal cell carcinoma.
Portugal I, Clavijo-Salomon MA. · · 2024 · PMID 39496729 · DOI 10.1038/s41698-024-00750-3
Verify or expand the search:
- PubMed search for NCT05877820
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT07518706 — Neoadjuvant Tislelizumab-Lenvatinib vs Surgery Alone in Stage Ia HCC With Narrow Margin · Phase 2 · not yet recruiting
Other RenJi Hospital trials
Trials by the same sponsor.
- NCT07584733 — Biomarker-Enriched Kidney-Preserving Strategy With Disitamab Vedotin Plus Tislelizumab in HER2-Positive High-Risk Upper · Phase 2 · not yet recruiting
- NCT07537725 — EEG-TMS for Postoperative Delirium After Cardiac Surgery · NA · not yet recruiting
- NCT07527936 — A Study of BEN301 Injection in theTreatment of Autoimmune Diseases · EARLY_PHASE1 · not yet recruiting
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- NCT07449793 — Biochemical Response and Clinical Outcomes in Patients With PBC · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05877820 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by RenJi Hospital
- Last refreshed: 31 August 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05877820.
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