Evidence map›Paper›PMID 41220738›Full record

ArticleJournal of gastrointestinal oncology2025

Adebrelimab combined with anlotinib plus hepatic arterial infusion chemotherapy or intravenous chemotherapy for first-line treatment of advanced biliary tract cancer: protocol for a randomized open-label clinical study.

Jie Zeng, Jie Liu, Fuchao Ma, Lihua Yang, Yanfeng Jiang, Ning Mo, Cuizhen Liu, Jing Tang, Xiaoqiang Fang, Zhiming Zeng and 1 more

Abstract read
In one paragraph

Article in Journal of gastrointestinal oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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

11 authors.

Jie Zeng *Department of Medical Oncology, The First Affiliated Hospital of Guangxi Medical University, Nanning, China.ORCID https://orcid.org/0000-0002-8582-7319
Jie Liu *Department of Neurosurgery, The First Affiliated Hospital of Guangxi Medical University, Nanning, China.
Fuchao MaDepartment of Medical Oncology, The First Affiliated Hospital of Guangxi Medical University, Nanning, China.
Lihua YangDepartment of Medical Oncology, The First Affiliated Hospital of Guangxi Medical University, Nanning, China.
Yanfeng JiangDepartment of Medical Oncology, The First Affiliated Hospital of Guangxi Medical University, Nanning, China.
Ning MoDepartment of Medical Oncology, The First Affiliated Hospital of Guangxi Medical University, Nanning, China.
Cuizhen LiuDepartment of Medical Oncology, The First Affiliated Hospital of Guangxi Medical University, Nanning, China.
Jing TangDepartment of Medical Oncology, The First Affiliated Hospital of Guangxi Medical University, Nanning, China.
Xiaoqiang FangJiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China.
Zhiming ZengDepartment of Medical Oncology, The First Affiliated Hospital of Guangxi Medical University, Nanning, China.
Jie MaDepartment of Medical Oncology, The First Affiliated Hospital of Guangxi Medical University, Nanning, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Malignancies of the biliary tract system, commonly termed biliary tract carcinoma (BTC), and primarily include cholangiocarcinoma (CC). BTC is most often diagnosed at an advanced stage, when surgical resection is no longer feasible, and systemic therapy is therefore frequently used. Immunotherapy, antiangiogenic targeted treatments, precision medicine, and chemotherapy have all improved the management of BTC in recent years. While arterial infusion chemotherapy has demonstrated notable efficacy in hepatocellular carcinoma, its role and outcomes in CC remain less defined, with limited and sometimes inconsistent study results, necessitating further investigation. However, these strategies continue to fall short of meeting full clinical needs, and limitations remain prominent. Methods: This randomized, open-label, multicenter phase II trial will enroll 60 participants with advanced BTC. The inclusion criteria comprised: age >18 years, advanced BTC diagnosis, no prior systemic therapy, at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, Eastern Cooperative Oncology Group (ECOG) performance status 0-1.Participants are randomized 1:1 to Cohort 1 [one cycle of hepatic arterial infusion gemcitabine + oxaliplatin (GEMOX) followed by one cycle of intravenous GEMOX] or Cohort 2 (two cycles of intravenous GEMOX). Both cohorts receive intravenous adebrelimab (1,200 mg, day 1) and oral anlotinib (12 mg daily, 2 weeks on/1 week off) per 21-day cycle. After combination chemotherapy, patients with clinical benefit continue adebrelimab plus anlotinib. We will conduct safety visits on the first day of each cycle. The primary endpoint is the 6-month progression-free survival (PFS) rate. Secondary endpoints include PFS, objective response rate, overall survival, and safety. Discussion: This trial aims to demonstrate the efficacy and safety of adebrelimab combined with anlotinib and GEMOX in advanced BTC, with an expectation that arterial infusion chemotherapy may improve 6-month PFS. We expect that arterial infusion chemotherapy may have better 6-month PFS rate. Trial Registration: This clinical trial has been registered on the Chinese Clinical Trial Registry. Clinical trial information: ChiCTR2500102333.

Indexed as

Advanced cholangiocarcinoma (advanced CC)arterial infusion chemotherapyimmunotherapy

Identifiers

PMID41220738
PMCPMC12598327

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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Registered trials

None linked

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 Socratic graph.