Evidence map›Paper›PMID 40658469›Full record

Trial reportThe oncologist2025

Combination therapy for platinum-resistant ovarian cancer: a novel at-home regimen with envafolimab, lenvatinib, and etoposide.

Bo Ding, Tianxiang Yu, Shiya Zheng, Jingyun Xu, Feng Ji, Hao Lin, Xiang Zhao, Shanhu Qiu, Yang Shen

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

Trial report in The oncologist, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05422183 (An Open, Single-arm Clinical Study of Envafolimab, Lenvatinib Combined With VP-16 in the Treatment of Platinum-resistant Recurrent Epithelial Ovarian Cancer,Primary Fallopian Tube Cancer and Primary Peritoneal Carcinoma), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

NCT05422183 phase2unknown statusnot on this map

An Open, Single-arm Clinical Study of Envafolimab, Lenvatinib Combined With VP-16 in the Treatment of Platinum-resistant Recurrent Epithelial Ovarian Cancer,Primary Fallopian Tube Cancer and Primary Peritoneal Carcinoma

TypeinterventionalSponsorZhongda HospitalRan2022 to 2023Enrolled20ConditionsOvarian Cancer, EpithelialArmsEnvafolimab, Lenvatinib, VP-16
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
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

9 authors.

Bo DingDepartment of Obstetrics and Gynecology, Zhongda Hospital, School of Medicine, Southeast University, Nanjing 210009, China.
Tianxiang YuDepartment of Obstetrics and Gynecology, Zhongda Hospital, School of Medicine, Southeast University, Nanjing 210009, China.
Shiya ZhengDepartment of Oncology, Zhongda Hospital, School of Medicine, Southeast University, Nanjing 210009, China.
Jingyun XuDepartment of Obstetrics and Gynecology, Zhongda Hospital, School of Medicine, Southeast University, Nanjing 210009, China.
Feng JiNanjing Key Laboratory of Intelligent Obstetrics and Gynecology Medicine, Zhongda Hospital, School of Medicine, Southeast University, Nanjing 210009, China.
Hao LinNanjing Key Laboratory of Intelligent Obstetrics and Gynecology Medicine, Zhongda Hospital, School of Medicine, Southeast University, Nanjing 210009, China.
Xiang ZhaoState Key Laboratory of Neurology and Oncology Drug Development, Jiangsu Simcere Diagnostics Co., Ltd, Nanjing Simcere Medical Laboratory Science Co., Ltd, Nanjing 210042, China.
Shanhu QiuDepartment of General Practice, Zhongda Hospital, Institute of Diabetes, School of Medicine, Southeast University, Nanjing 210009, China.
Yang ShenDepartment of Obstetrics and Gynecology, Zhongda Hospital, School of Medicine, Southeast University, Nanjing 210009, China.ORCID 0000-0002-3313-5062

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEffective and tolerable treatment for patients with platinum-resistant recurrent ovarian cancer remains a great challenge in clinical practice. This study aimed to evaluate the efficacy and safety of envafolimab, the first subcutaneously administered programmed death ligand 1 (PD-L1) inhibitor, combined with lenvatinib and etoposide in patients with platinum-resistant recurrent ovarian cancer.

methodsThis was an open-label, single-arm, phase 2 trial (ENLEN-OC-001). Patients with platinum-resistant recurrent ovarian cancer were eligible for inclusion who were administered envafolimab subcutaneously on day 1 and lenvatinib and etoposide orally on days 1-14, with 21 days as a cycle. After 6-10 cycles, envafolimab and lenvatinib were taken as maintenance therapy until intolerable toxicity, disease progression, withdrawal of consent, or finishing 24 months of treatment. The primary endpoint was objective response rate (ORR), and the secondary endpoints included disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety.

resultsOf the screened 28 patients, 21 were included, with 18 being assessed for the efficacy and safety. The ORR was 44.4% (95% CI 21.5%-69.2%), and the DCR was 83.3% (95% CI 58.6%-96.4%). The median PFS was 10.2 months (95% CI 5.6-not applicable [NA]), and the median OS was 21.3 months (95% CI 6.8-NA). The most common grade 3/4 adverse events were leukopenia (27.8%) and thrombocytopenia (16.7%). No serious adverse events or treatment-related deaths were reported. No changes were observed in the depression, anxiety, and quality of life following treatment.

conclusionEnvafolimab combined with lenvatinib and etoposide showed promising efficacy and tolerable safety for patients with platinum-resistant recurrent ovarian cancer. CLINICALTRIALS.GOV IDENTIFIER: NCT05422183.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsEtoposideOvarian NeoplasmsPhenylurea CompoundsPlatinum CompoundsQuinolinesAdultAgedDrug Resistance, NeoplasmFemaleHumansMiddle AgedNeoplasm Recurrence, LocalEtoposidelenvatinibPhenylurea CompoundsPlatinum CompoundsQuinolinesat-home regimencombination therapyovarian cancerplatinum-resistant

Identifiers

PMID40658469
PMCPMC12404298

What OpenQuestion holds

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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.