Evidence map›Paper›PMID 40810951›Full record

Trial reportJAMA oncology2025

Sintilimab Plus Axitinib for Advanced Fumarate Hydratase-Deficient Renal Cell Carcinoma: A Phase 2 Nonrandomized Clinical Trial.

Xingming Zhang, Haoyang Liu, Jiayu Liang, Junjie Zhao, Yongquan Wang, Yuntian Chen, Deying Kang, Qian Chen, Yaowen Zhang, Xiaoxue Yin and 35 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in JAMA oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04387500 (Single-arm Phase II Clinical Trial to Evaluate the Initial Efficacy and Safety of Sintilimab Injection Combined With Inlyta in Fumarate Hydratase- Deficient Renal Cell Carcinoma), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

NCT04387500 phase2unknown statusnot on this map

Single-arm Phase II Clinical Trial to Evaluate the Initial Efficacy and Safety of Sintilimab Injection Combined With Inlyta in Fumarate Hydratase- Deficient Renal Cell Carcinoma

TypeinterventionalSponsorWest China HospitalRan2021 to 2026Enrolled41ConditionsCarcinoma, Renal Cell, Fumarate Hydratase Deficiency, ImmunotherapyArmsSintilimab injection plus Inlyta treatment
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Observational
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

45 authors.

Xingming ZhangDepartment of Urology, Institute of Urology, Sichuan Clinical Research Center for Kidney and Urologic Diseases, West China Hospital, Sichuan University, Chengdu, China.
Haoyang LiuDepartment of Urology, Institute of Urology, Sichuan Clinical Research Center for Kidney and Urologic Diseases, West China Hospital, Sichuan University, Chengdu, China.
Jiayu LiangDepartment of Urology, Institute of Urology, Sichuan Clinical Research Center for Kidney and Urologic Diseases, West China Hospital, Sichuan University, Chengdu, China.
Junjie ZhaoDepartment of Urology, Institute of Urology, Sichuan Clinical Research Center for Kidney and Urologic Diseases, West China Hospital, Sichuan University, Chengdu, China.
Yongquan WangDepartment of Urology, Southwest Hospital, Army Medical University, Chongqing, China.
Yuntian ChenDepartment of Radiology, West China Hospital, Sichuan University, Chengdu, China.
Deying KangDepartment of Clinical Research Management, West China Hospital, Sichuan University, Chengdu, China.
Qian ChenDepartment of Clinical Research Management, West China Hospital, Sichuan University, Chengdu, China.
Yaowen ZhangDepartment of Obstetrics and Gynecology, Key Laboratory of Birth Defects and Related Diseases of Women and Children, Ministry of Education, West China Second University Hospital, Sichuan University, Chengdu, China.
Xiaoxue YinDepartment of Pathology, West China Hospital, Sichuan University, Chengdu, China.
Yuhao ZengDepartment of Urology, Institute of Urology, Sichuan Clinical Research Center for Kidney and Urologic Diseases, West China Hospital, Sichuan University, Chengdu, China.
Zilin WangDepartment of Urology, Institute of Urology, Sichuan Clinical Research Center for Kidney and Urologic Diseases, West China Hospital, Sichuan University, Chengdu, China.
Xinan ShengKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Genitourinary Oncology, Peking University Cancer Hospital and Institute, Beijing, China.
Xin YaoDepartment of Medical Oncology, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Tianjin, China.
Kan GongDepartment of Urology, Peking University First Hospital, Beijing, China.
Xiaodong LiuThe First Affiliated Hospital of Kunming Medical University, Kunming, China.
Zhibin ChenDepartment of Urology, The First People's Hospital of Neijiang, Neijiang, China.
Mingxing QiuDepartment of Urology, Sichuan Provincial People's Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.
Wei ChenDepartment of Urology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.
Zongping WangDepartment of Urology, Zhejiang Cancer Hospital, Hangzhou, China.
Guangheng LuoDepartment of Urology, Guizhou Provincial People's Hospital, Guiyang, China.
Tingting ZhouDepartment of Urology, The General Hospital of Western Theater Command, Chengdu, China.
Nanshan YangResearch Institute, GloriousMed Clinical Laboratory, Shanghai, China.
Xiuyi PanDepartment of Pathology, West China Hospital, Sichuan University, Chengdu, China.
Ling NieDepartment of Pathology, West China Hospital, Sichuan University, Chengdu, China.
Mengni ZhangDepartment of Pathology, West China Hospital, Sichuan University, Chengdu, China.
Junru ChenDepartment of Urology, Institute of Urology, Sichuan Clinical Research Center for Kidney and Urologic Diseases, West China Hospital, Sichuan University, Chengdu, China.
Jinge ZhaoDepartment of Urology, Institute of Urology, Sichuan Clinical Research Center for Kidney and Urologic Diseases, West China Hospital, Sichuan University, Chengdu, China.
Xu HuDepartment of Urology, Institute of Urology, Sichuan Clinical Research Center for Kidney and Urologic Diseases, West China Hospital, Sichuan University, Chengdu, China.
Lijing XuDepartment of Urology, Institute of Urology, Sichuan Clinical Research Center for Kidney and Urologic Diseases, West China Hospital, Sichuan University, Chengdu, China.
Bo TangDepartment of Urology, Institute of Urology, Sichuan Clinical Research Center for Kidney and Urologic Diseases, West China Hospital, Sichuan University, Chengdu, China.
Jindong DaiDepartment of Urology, Institute of Urology, Sichuan Clinical Research Center for Kidney and Urologic Diseases, West China Hospital, Sichuan University, Chengdu, China.
Haolin LiuDepartment of Urology, Institute of Urology, Sichuan Clinical Research Center for Kidney and Urologic Diseases, West China Hospital, Sichuan University, Chengdu, China.
Yuchao NiDepartment of Urology, Institute of Urology, Sichuan Clinical Research Center for Kidney and Urologic Diseases, West China Hospital, Sichuan University, Chengdu, China.
Rui HuangDepartment of Nuclear Medicine, West China Hospital, Sichuan University, Chengdu, China.
Qiang WeiDepartment of Urology, Institute of Urology, Sichuan Clinical Research Center for Kidney and Urologic Diseases, West China Hospital, Sichuan University, Chengdu, China.
Xiang LiDepartment of Urology, Institute of Urology, Sichuan Clinical Research Center for Kidney and Urologic Diseases, West China Hospital, Sichuan University, Chengdu, China.
Qiying HeDepartment of Urology, Institute of Urology, Sichuan Clinical Research Center for Kidney and Urologic Diseases, West China Hospital, Sichuan University, Chengdu, China.
Jiyan LiuDepartment of Biotherapy, West China Hospital, Sichuan University, Chengdu, China.
Pengfei ShenDepartment of Urology, Institute of Urology, Sichuan Clinical Research Center for Kidney and Urologic Diseases, West China Hospital, Sichuan University, Chengdu, China.
Ni ChenDepartment of Pathology, West China Hospital, Sichuan University, Chengdu, China.
Zhenhua LiuDepartment of Urology, Institute of Urology, Sichuan Clinical Research Center for Kidney and Urologic Diseases, West China Hospital, Sichuan University, Chengdu, China.
Guangxi SunDepartment of Urology, Institute of Urology, Sichuan Clinical Research Center for Kidney and Urologic Diseases, West China Hospital, Sichuan University, Chengdu, China.
Jin YaoDepartment of Radiology, West China Hospital, Sichuan University, Chengdu, China.
Hao ZengDepartment of Urology, Institute of Urology, Sichuan Clinical Research Center for Kidney and Urologic Diseases, West China Hospital, Sichuan University, Chengdu, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Importance: Fumarate hydratase-deficient renal cell carcinoma (FH-deficient RCC) is a lethal kidney cancer that has limited therapeutic options. Objective: To evaluate the efficacy and safety of sintilimab plus axitinib for treatment of advanced FH-deficient RCC. Design, Setting, and Participants: This phase 2 multicenter, open-label, single-arm nonrandomized clinical trial enrolled patients with pathologically confirmed, treatment-naive, advanced FH-deficient RCC and an Eastern Cooperative Oncology Group Performance Status of 0 to 2 from July 1, 2021, to August 29, 2023, across 8 institutions in China. The data cutoff date was December 1, 2024. Intervention: Patients received sintilimab, 200 mg, intravenously every 3 weeks, combined with axitinib, 5 mg, orally twice daily, until disease progression, intolerable toxic effects, or withdrawal of consent. Main Outcomes and Measures: The primary end points were objective response rate (ORR) via Response Evaluation Criteria in Solid Tumors, version 1.1, and progression-free survival (PFS). Secondary end points included safety, overall survival, disease control rate (proportion of patients with complete or partial response or stable disease for ≥6 months), duration of response, and exploratory genomic-associated outcomes. Results: Of 52 patients screened for eligibility, 41 patients (median [range] age, 36 [18-75] years; 10 [24%] female) were enrolled. The median (range) duration of follow-up was 26.0 (0.7-41.6) months. Overall, ORR was 56% (23 patients; 95% CI, 40%-72%), with a median duration of response of not reached (NR; 95% CI, 23.3 months to NR). The disease control rate was 73% (30 patients). The median PFS was 19.8 months (95% CI, 10.9 months to NR). Patients with low somatic copy number alteration burden showed more favorable therapeutic outcomes. Thirteen patients (32%) experienced grade 3 or higher treatment-related adverse events, with the most frequent being hypertriglyceridemia in 3 (7%), rash in 2 (5%), and anemia in 2 (5%). Conclusions and Relevance: In this nonrandomized clinical trial, the combination of sintilimab and axitinib demonstrated encouraging ORR and PFS with manageable safety profile in patients with FH-deficient RCC. This combination therapy warrants further validation in a randomized clinical trial. Trial Registration: ClinicalTrials.gov Identifier: NCT04387500.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsAxitinibCarcinoma, Renal CellFumarate HydrataseKidney NeoplasmsAdultAgedFemaleHumansMaleMiddle AgedProgression-Free SurvivalAntibodies, Monoclonal, HumanizedAxitinibFumarate Hydratasesintilimab

Identifiers

PMID40810951
PMCPMC12355386

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.