Evidence map›Paper›PMID 41176543›Full record

Trial reportNature cancer2026

Cryoablation plus sintilimab and lenvatinib in advanced or metastatic intrahepatic cholangiocarcinoma: a phase 2 trial.

Sijia Gu, Qiyu Luo, Yalei Zhang, Ling Qian, Kun Chen, Fei Liang, Yudi Hu, Runye Zhou, Yating Wang, Jingjing Liu and 5 more

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

Trial report in Nature cancer, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05010668 (A Phase II Study of Cryoablation Combined With Sintilimab Plus Lenvatinib in Patients With Advanced Intrahepatic Cholangiocarcinoma), which is not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing 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.

NCT05010668 phase2completednot on this map

A Phase II Study of Cryoablation Combined With Sintilimab Plus Lenvatinib in Patients With Advanced Intrahepatic Cholangiocarcinoma (CASTLE-01)

TypeinterventionalSponsorFudan UniversityRan2021 to 2024Enrolled28ConditionsIntrahepatic CholangiocarcinomaArmscryoablation, Sintilimab, lenvatinib
3 · Its place in the literature

Who cites it

12 citing papers in PubMed.

  1. Review
  2. Article
  3. [Interventional therapeutic strategies for metastatic liver cancer].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2026
    Review
  4. Review
  5. Article
  6. Article
  7. Article
  8. [Research progress in liver cancer in 2025].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2026
    Review
  9. Review
  10. Review
  11. Review
  12. 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

15 authors.

Sijia Gu *Department of Hepatobiliary Oncology, Zhongshan Hospital, Fudan University, Shanghai, China.
Qiyu Luo *Department of Hepatobiliary Oncology, Zhongshan Hospital, Fudan University, Shanghai, China.
Yalei ZhangDepartment of Hepatobiliary Oncology, Zhongshan Hospital, Fudan University, Shanghai, China.
Ling QianDepartment of Hepatobiliary Oncology, Zhongshan Hospital, Fudan University, Shanghai, China.
Kun ChenDepartment of Hepatobiliary Oncology, Zhongshan Hospital, Fudan University, Shanghai, China.
Fei LiangDepartment of Biostatistics, Clinical Research Unit, Institute of Clinical Science, Zhongshan Hospital, Fudan University, Shanghai, China.ORCID http://orcid.org/0000-0002-4184-7844
Yudi HuDepartment of Hepatobiliary Oncology, Zhongshan Hospital, Fudan University, Shanghai, China.
Runye ZhouDepartment of Hepatobiliary Oncology, Zhongshan Hospital, Fudan University, Shanghai, China.
Yating WangDepartment of Hepatobiliary Oncology, Zhongshan Hospital, Fudan University, Shanghai, China.
Jingjing LiuDepartment of Hepatobiliary Oncology, Zhongshan Hospital, Fudan University, Shanghai, China.
Zhouyu NingDepartment of Integrative Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Litao XuDepartment of Integrative Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Zhiqiang MengDepartment of Integrative Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Ye LiDepartment of Hepatobiliary Oncology, Zhongshan Hospital, Fudan University, Shanghai, China. li_ye@fudan.edu.cn.
Peng WangDepartment of Hepatobiliary Oncology, Zhongshan Hospital, Fudan University, Shanghai, China. peng_wang@fudan.edu.cn.ORCID http://orcid.org/0000-0003-0569-9001

Funding

National Natural Science Foundation of China (National Science Foundation of China) 82025035National Natural Science Foundation of China (National Science Foundation of China) 82104612National Natural Science Foundation of China (National Science Foundation of China) 82230122
6 · The paper itself

Abstract

Treatment options for advanced or metastatic intrahepatic cholangiocarcinoma (ICC) are limited. In this single-arm, phase 2 trial (CASTLE-01, NCT05010668 ), 28 participants with advanced or metastatic ICC who have progressed after chemotherapy were treated with cryoablation, followed by anti-PD1 sintilimab (200 mg every 3 weeks) plus lenvatinib (8-12 mg per day) 2 weeks later. The objective response rate assessed by Response Evaluation Criteria in Solid Tumors version 1.1 was 75.0% (95% confidence interval (CI): 59-91%), meeting the prespecified primary endpoint. Secondary endpoints of disease control rate, median progression-free survival and overall survival were respectively 100% (95% CI: 100-100%), 16.8 months (95% CI: 11.5-not reached (NR)) and 25.4 months (95% CI: 13.3-NR). Treatment was well tolerated. Post hoc multiomics analysis of paired pretreatment and on-treatment tumor biopsies suggested that cryoablation increased the tumor immunogenicity and dendritic cell activation, followed by triggering continuous replenishment of intratumoral CD8

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBile Duct NeoplasmsCholangiocarcinomaCryosurgeryPhenylurea CompoundsQuinolinesAdultAgedAged, 80 and overCombined Modality TherapyFemaleHumansMaleMiddle AgedTreatment OutcomeAntibodies, Monoclonal, HumanizedlenvatinibPhenylurea CompoundsQuinolinessintilimab

Identifiers

PMID41176543
PMCPMC12858403

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.