Evidence map›Paper›PMID 32832493›Full record

ArticleHepatobiliary surgery and nutrition2020

Pembrolizumab combined with lenvatinib as non-first-line therapy in patients with refractory biliary tract carcinoma.

Jianzhen Lin, Xu Yang, Junyu Long, Songhui Zhao, Jinzhu Mao, Dongxu Wang, Yi Bai, Jin Bian, Lei Zhang, Xiaobo Yang and 13 more

4 registry-linked trialsOpen access · diamondAbstract read
In one paragraph

Article in Hepatobiliary surgery and nutrition, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 98 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
98citing papers in PubMed, 3 pooled it
20.4field-weighted citation impact, top 1% of its field
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.

NCT03892577 unknown statusnot on this map

Real-world Study for Targeted Therapy and Immunotherapy in Patients With Advanced Hepatobiliary Tumors: a Multi-centers, Open-assess Observational Study.

Typeobservational_patient_registrySponsorPeking Union Medical College HospitalRan2017 to 2025Enrolled3,000ConditionsObjective Response Rate, Progression-free Survival, Overall Survival, Disease Control RateArmsPrecision oncology including targeted therapy and immunotherapy
NCT03895970 phase2completednot on this map

Lenvatinib Combined Pembrolizumab as a Second-line Treatment in Advanced Hepatobiliary Tumors: a Single-center, Single-arm, Non-randomized Clinical Study

TypeinterventionalSponsorPeking Union Medical College HospitalRan2019 to 2021Enrolled32ConditionsLiver Neoplasm Malignant Primary, Cholangiocarcinoma, Combinational Immunotherapy, BiomarkerArmsLenvatinib plus Pembrolizumab
NCT04720131 phase2completednot on this mapstarted 2021, after this paper: background citation

Camrelizumab Combined With Apatinib and Capecitabine for Patients With Advanced Biliary Tract Cancer: a Phase 2, Single-arm, Prospective Study.

TypeinterventionalSponsorBeijing Friendship HospitalRan2021 to 2023Enrolled28ConditionsBiliary Tract Cancer, Anti-PD-1 Therapy, Targeted Molecular Therapy, CapecitabineArmsCamrelizumab, apatinib, Capecitabine
NCT06648057 recruitingnot on this mapstarted 2024, after this paper: background citation

Investigation of Predictive Biomarkers in Patients With Advanced Biliary Tract Cancer Treated With Lenvatinib Plus Pembrolizumab

TypeobservationalSponsorCHA UniversityRan2024 to 2026Enrolled100ConditionsBiliary Tract Cancer, CholangiocarcinomaArmslenvatinib plus pembrolizumab
3 · Its place in the literature

Who cites it

98 citing papers in PubMed, 3 syntheses or guidelines pooled it, 154 citations in OpenAlex.

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  20. Lenvatinib inhibits cholangiocarcinoma progression by targeting the FGF19/PI3K/AKT signaling pathway.Apoptosis : an international journal on programmed cell death · 2025
    Article

38 more citing papers are in PubMed but not listed here.

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

23 authors at 4 institutions in 1 country.

Jianzhen LinDepartment of Liver Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College (CAMS & PUMC), Beijing 100730, China.
Xu YangDepartment of Liver Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College (CAMS & PUMC), Beijing 100730, China.
Junyu LongDepartment of Liver Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College (CAMS & PUMC), Beijing 100730, China.
Songhui ZhaoOrigiMed, Shanghai 200135, China.
Jinzhu MaoDepartment of Liver Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College (CAMS & PUMC), Beijing 100730, China.
Dongxu WangDepartment of Liver Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College (CAMS & PUMC), Beijing 100730, China.
Yi BaiDepartment of Liver Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College (CAMS & PUMC), Beijing 100730, China.
Jin BianDepartment of Liver Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College (CAMS & PUMC), Beijing 100730, China.
Lei ZhangDepartment of Liver Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College (CAMS & PUMC), Beijing 100730, China.
Xiaobo YangDepartment of Liver Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College (CAMS & PUMC), Beijing 100730, China.
Anqiang WangDepartment of Gastrointestinal Surgery, Peking University Cancer Hospital & Institute, Beijing 100142, China.
Fucun XieDepartment of Liver Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College (CAMS & PUMC), Beijing 100730, China.
Weiwei ShiOrigiMed, Shanghai 200135, China.
Huayu YangDepartment of Liver Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College (CAMS & PUMC), Beijing 100730, China.
Jie PanDepartment of Radiology, Peking Union Medical College Hospital, Beijing 100730, China.
Ke HuCenter of Radiotherapy, Peking Union Medical College Hospital, Beijing 100730, China.
Mei GuanDepartment of Medical Oncology, Peking Union Medical College Hospital, Beijing 100730, China.
Lin ZhaoDepartment of Medical Oncology, Peking Union Medical College Hospital, Beijing 100730, China.
Li HuoDepartment of Nuclear Medicine, Peking Union Medical College Hospital, Beijing 100730, China.
Yilei MaoDepartment of Liver Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College (CAMS & PUMC), Beijing 100730, China.
Xinting SangDepartment of Liver Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College (CAMS & PUMC), Beijing 100730, China.
Kai WangOrigiMed, Shanghai 200135, China.
Haitao ZhaoDepartment of Liver Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College (CAMS & PUMC), Beijing 100730, China.
Peking Union Medical College Hospital · CNChinese Academy of Medical Sciences & Peking Union Medical College · CNUnimed Medical Institute · CNPeking University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA therapeutic strategy involving combined treatment with lenvatinib plus pembrolizumab (LEP) has demonstrated a relatively high antitumor response in several solid tumors; however, the efficacy and safety of LEP in patients with refractory bile tract carcinoma (BTC) remains unknown.

methodsThis is a single-arm study for a preliminary assessment of the efficacy and tolerability of LEP in patients who experienced progression from prior systemic treatments. Pre-treatment tumor tissues were collected to retrospectively evaluate the expression status of PDL1.

resultsThirty-two patients received second-line and above treatment with LEP. Overall, the objective response rate (ORR) was 25%, the disease control rate (DCR) was 78.1%, and the clinical benefit rate (CBR) was 40.5%. The median progression-free survival (PFS) was 4.9 months (95% CI: 4.7-5.2 months), and the median overall survival (OS) was 11.0 months (95% CI: 9.6-12.3 months). For tolerability, no grade 5 serious adverse events (AEs) were reported. All patients had any-grade AEs, and 59.3% of the patients experienced grade 3 AEs, while only 1 patient experienced a grade 4 AE of stomach bleeding. Fatigue was the most common AE, followed by hypertension and elevated aminotransferase levels. Retrospective analysis for PDL1 expression revealed that PDL1 positive tumor cells were associated with improved clinical benefits and survival outcomes.

conclusionsLEP is a promising alternative as a non-first-line therapeutic regimen for patients with refractory BTC. Furthermore, well-designed prospective clinical trials with a control arm are still needed to obtain more evidences to confirm the efficacy and safety of this particular regimen as well as the role of PDL1 expression.

Indexed as

bile tract cancerlenvatinibPD1PDL1Pembrolizumab

Identifiers

PMID32832493
PMCPMC7423565
OpenAlexW3031297691

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.