Evidence map›Paper›PMID 42844281›Full record

Trial reportNature communications2026

Tislelizumab plus lenvatinib in advanced fumarate hydratase-deficient renal cell carcinoma: a single-arm, phase 2 trial with metabolic biomarker analysis.

Wen Kong, Yunze Xu, Guiqin Liu, Wenwen Lv, Zaoyu Wang, Dengfeng Cao, Feng Jiao, Jiong Hu, Xiaoyu Wu, Jiwei Huang and 9 more

Registry-linked trialAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Nature communications, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05877820 (A Prospective, Single Arm Clinical Study to Evaluate Efficacy and Safety of Lenvatinib Combined With Tislelizumab in the First Line Treatment of Patients With Locally Advanced or Metastastic Fumarate Hydratase Deficient Renal Cell Carcinoma), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05877820 phase2unknown statusnot on this map

A Prospective, Single Arm Clinical Study to Evaluate Efficacy and Safety of Lenvatinib Combined With Tislelizumab in the First Line Treatment of Patients With Locally Advanced or Metastastic Fumarate Hydratase Deficient Renal Cell Carcinoma

TypeinterventionalSponsorRenJi HospitalRan2023 to 2025Enrolled10ConditionsFumarate Hydratase Deficient Renal Cell CarcinomaArmsTislelizumab, Lenvatinib
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors.

Wen Kong *Department of Urology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.ORCID 0000-0002-2326-3220
Yunze Xu *Department of Urology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.ORCID 0009-0006-1984-3624
Guiqin Liu *Department of Radiology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.ORCID 0000-0003-4400-9472
Wenwen LvClinical Research Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.ORCID 0000-0002-3386-8813
Zaoyu WangDepartment of Pathology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Dengfeng CaoDepartment of Pathology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Feng JiaoDepartment of Medical Oncology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Jiong HuDepartment of Medical Oncology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Xiaoyu WuPediatric Translational Medicine Institute, Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Jiwei HuangDepartment of Urology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Yonghui ChenDepartment of Urology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Wei ZhaiDepartment of Urology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.ORCID 0000-0001-6274-6404
Xiaorong WuDepartment of Urology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Jiahua PanDepartment of Urology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.ORCID 0009-0000-2126-7335
Yiran HuangDepartment of Urology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Guangyu WuDepartment of Radiology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. danielrau@163.com.ORCID 0009-0009-1789-9108
Liang ZhengPediatric Translational Medicine Institute, Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China. lzheng@shsmu.edu.cn.ORCID 0000-0002-5346-4111
Wei XueDepartment of Urology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. uroxuewei@163.com.ORCID 0000-0001-9298-9941
Jin ZhangDepartment of Urology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. zhangjin@renji.com.ORCID 0009-0008-9046-1519

Funding

National Natural Science Foundation of China (National Science Foundation of China) 82371912
6 · The paper itself

Abstract

Fumarate hydratase-deficient renal cell carcinoma (FH-RCC) is a rare, aggressive kidney cancer with no established standard of care. This phase 2 trial (NCT05877820) assessed first-line tislelizumab plus lenvatinib in advanced FH-RCC (N = 20). The primary endpoint was objective response rate (ORR); secondary endpoints included progression-free survival (PFS), overall survival (OS), disease control rate (DCR), duration of response (DOR) and safety. After a median follow-up of 20.2 months, ORR was 95% (95% CI 75.1-99.9), and DCR was 100% (95% CI 83.2-100). Median PFS was 20.7 months (95% CI 17.8-NR), median DOR was 19.2 months (95% CI 16.3-NR) and 2-year OS rate was 89.7% (95% CI 77.2-100). Grade ≥3 treatment-related adverse events occurred in 45% of patients. Circulating succinyl-adenosine and succinic-cysteine tracked radiographic tumor burden in 80% of patients. Limitations include the single-center, single-arm design, and limited sample size. These results support tislelizumab plus lenvatinib as a potential first-line option for advanced FH-RCC, with favorable antitumor activity and manageable safety profile. Circulating succinate-modifying metabolites may complement response monitoring but require further validation.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Renal CellFumarate HydrataseKidney NeoplasmsPhenylurea CompoundsQuinolinesAdultAgedBiomarkers, TumorFemaleHumansMaleMiddle AgedProgression-Free SurvivalAntibodies, Monoclonal, HumanizedBiomarkers, TumorFumarate HydrataselenvatinibPhenylurea CompoundsQuinolines

Identifiers

PMID42844281
PMCPMC13645792

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.