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NCT04146831
Sintilimab in FH-deficient Renal Cell Carcinoma
Status unknown
Phase 2
Last updated 12 May 2020
What this trial tests
Phase 2 trial testing Sintilimab in Renal Cell Carcinoma in 37 participants. Status unknown.
Timeline
1 June 2020
Primary endpoint
1 June 2022
1 June 2022
1 April 2023
Quick facts
| Lead sponsor | West China Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 37 |
| Start date | 1 June 2020 |
| Primary completion | 1 June 2022 |
| Estimated completion | 1 April 2023 |
Drugs / interventions tested
- Sintilimab — full drug profile →
Conditions studied
- Renal Cell Carcinoma — all drugs for Renal Cell Carcinoma →
- FH-deficient — all drugs for FH-deficient →
- Sintilimab — all drugs for Sintilimab →
Sponsor
West China Hospital
Who can join
18 and older, any sex, with Renal Cell Carcinoma or FH-deficient. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
Targeting strategies in the treatment of fumarate hydratase deficient renal cell carcinoma.
Lindner AK, Tulchiner G, Seeber A, Siska PJ, et al · · 2022 · cited 27× · PMID 35912170 · DOI 10.3389/fonc.2022.906014 -
Clinical potential of PD-1/PD-L1 blockade therapy for renal cell carcinoma (RCC): a rapidly evolving strategy.
Jahangir M, Yazdani O, Yazdani O, Kahrizi MS, et al · · 2022 · cited 15× · PMID 36510217 · DOI 10.1186/s12935-022-02816-3 -
Hereditary Leiomyomatosis and Renal Cell Cancer: Recent Insights Into Mechanisms and Systemic Treatment.
Zhang C, Li L, Zhang Y, Zeng C. · · 2021 · cited 13× · PMID 34113573 · DOI 10.3389/fonc.2021.686556 -
Implications of Fumarate Hydratase Deficiency (FHD) and Cancer Risk: A Window into the Clinical and Oncological Implications of a Rare Disorder in Gynecology.
D'Indinosante M, Lardino S, Bruno M, Stabile G, et al · · 2025 · cited 2× · PMID 40002168 · DOI 10.3390/cancers17040573 -
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 -
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 NCT04146831
- Europe PMC full search
- ASCO Meeting Library
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Related trials
Other trials of Sintilimab
Trials testing the same drug.
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Other recruiting trials for Renal Cell Carcinoma
Currently open trials in the same condition.
- NCT07397611 — Pre-NEOSHIFT-RCC: Neoadjuvant HIF-Inhibitor Immunotherapy in RCC · Phase 2 · recruiting
- NCT07195682 — A First-in-Human Study of BMS-986506 in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC) · Phase 1 · recruiting
- NCT07285044 — The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Tr · Phase 2 · recruiting
- NCT07227402 — A Clinical Study of Belzutifan and Zanzalintinib in People With Recurrent Kidney Cancer Following Adjuvant Therapy (MK-6 · Phase 3 · recruiting
- NCT07123090 — A Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma · Phase 2 · recruiting
Other West China Hospital trials
Trials by the same sponsor.
- NCT07583654 — Safety, Tolerability, and Preliminary Antitumor Activity of Cationic Peptide-IL22BP mRNA in Advanced Solid Tumors · Phase 1 · not yet recruiting
- NCT07583914 — Safety, Tolerability, and Preliminary Antitumor Activity of Non-Cationic Peptide-CD47 siRNA in Advanced Solid Tumors · Phase 1 · not yet recruiting
- NCT07492914 — Neoadjuvant Sacituzumab Govitecan Plus Tagitanlimab for Resectable Head and Neck Squamous Cell Carcinoma · Phase 2 · recruiting
- NCT07507097 — Study on the Optimal Head Position for Patients With Severe Acute Ischemic Stroke · NA · not yet recruiting
- NCT07472933 — Vebotolimab Combined With Ptorlimab for EGFR-positive Refractory Advanced Biliary Tract Malignancies · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT04146831 (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 West China Hospital
- Last refreshed: 12 May 2020
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/NCT04146831.
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