Evidence map›Paper›PMID 38637772›Full record

Trial reportBMC medicine2024

Anti-PD-1 antibody in combination with radiotherapy as first-line therapy for unresectable intrahepatic cholangiocarcinoma.

Meiyan Zhu, Meng Jin, Xiao Zhao, Shunli Shen, Yihan Chen, Han Xiao, Guangyan Wei, Qiang He, Bin Li, Zhenwei Peng

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03898895 (Combination of Radiotherapy With Anti-PD-1 Antibody for Unresectable Biliary Tract Cancer), which is not on this map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
11.5field-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.

NCT03898895 phase2unknown statusnot on this map

Combination of Radiotherapy With Anti-PD-1 Antibody for Unresectable Biliary Tract Cancer

TypeinterventionalSponsorSun Yat-sen UniversityRan2019 to 2024Enrolled36ConditionsBiliary Tract Cancer, Radiotherapy, ImmunotherapyArmsRadiotherapy+anti-PD-1 antibody
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 20 citations in OpenAlex.

  1. Trial
  2. Review
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  4. Article
  5. Article
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  15. Role of Radiation Therapy for Biliary Tract Cancers.Current oncology (Toronto, Ont.) · 2025
    Review
  16. Review
  17. Review
  18. Article
  19. Clinical Medicine Insights. Oncology · 2025
    Article
  20. 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

10 authors at 1 institution in 1 country.

Meiyan Zhu *Department of Radiation Oncology, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, 510080, China.
Meng Jin *Department of Radiation Oncology, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, 510080, China.
Xiao Zhao *Department of Radiation Oncology, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, 510080, China.
Shunli Shen *Department of Liver Surgery, Center of Hepato-Pancreato-Biliary Surgery, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, 510080, China.
Yihan ChenKey Laboratory for Stem Cells and Tissue Engineering, Ministry of Education, Sun Yat-sen University, Guangzhou, 510080, China.
Han XiaoDivision of Interventional Ultrasound, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, 510080, China.
Guangyan WeiDepartment of Radiation Oncology, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, 510080, China.
Qiang HeDepartment of Liver Surgery, Center of Hepato-Pancreato-Biliary Surgery, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, 510080, China.
Bin LiClinical Trials Unit, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, 510080, China.
Zhenwei PengDepartment of Radiation Oncology, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, 510080, China. pzhenw@mail.sysu.edu.cn.
Sun Yat-sen University · CN

Funding

Doctor of excellence program (DEP), The First Hospital of Jilin University JDYY-DEP-2023028National Natural Science Foundation of China 82072029
6 · The paper itself

Abstract

backgroundUnresectable intrahepatic cholangiocarcinoma (iCCA) has a poor prognosis despite treatment with standard combination chemotherapy. We aimed to evaluate the efficacy and safety of radiotherapy in combination with an anti-PD-1 antibody in unresectable iCCA without distant metastases.

methodsIn this phase II study, patients with histopathologically confirmed unresectable primary or postoperative recurrent iCCA without distant metastases were enrolled. Patients received external radiotherapy with a dose of ≥45 Gy (2-2.5 Gy per fraction), followed by anti-PD-1 immunotherapy (camrelizumab 200 mg once, every 3 weeks) initiated within 7 days after completion of radiotherapy as first-line therapy. The primary endpoint was 1-year progression-free survival (PFS) rate. The secondary end points included safety, objective response rate (ORR), disease control rate (DCR), and overall survival (OS).

resultsFrom December 2019 to March 2021, 36 patients completed radiotherapy and at least one cycle of immunotherapy and were included in efficacy and safety analyses. The median follow-up was 19.0 months (IQR 12.0-24.0), and the one-year PFS rate was 44.4% (95% CI, 30.8-64.0). The median PFS was 12.0 months (95% CI, 7.5-not estimable); the median OS was 22.0 months (95% CI, 15.0-not estimable). The ORR was 61.1% and the DCR was 86.1%. Seventeen of 36 (47.2%) patients experienced treatment-related adverse effects (AEs) of any grade. The most common AE was reactive cutaneous capillary endothelial proliferation (25.0%). Five (13.9%) patients experienced grade ≥3 treatment-related AEs, including decreased lymphocyte (5.6%), bullous dermatitis (2.8%), decreased platelet count (2.8%), and deep-vein thrombosis (2.8%).

conclusionsExternal radiotherapy plus camrelizumab, as first-line therapy, met its primary endpoint and showed antitumor activity and low toxicity levels in patients with unresectable iCCA without distant metastases, warranting further investigation.

trial registrationNCT03898895. Registered 2 April 2019.

Indexed as

Bile Duct NeoplasmsCholangiocarcinomaDrug-Related Side Effects and Adverse ReactionsBile Ducts, IntrahepaticDrug Therapy, CombinationHumansImmunotherapyImmunotherapyIntrahepatic cholangiocarcinomaProgrammed death ligand-1Radiotherapy

Identifiers

PMID38637772
PMCPMC11027363
OpenAlexW4394960729

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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.