Evidence map›Paper›PMID 40889502›Full record

Trial reportThe Lancet. Oncology2025

Conversion therapy of tislelizumab plus lenvatinib and GEMOX in unresectable locally advanced biliary tract cancer (ZSAB-TransGOLP): a multicentre, prospective, phase 2 study.

Guoming Shi, Xiaoyong Huang, Xiaowu Li, Fei Liang, Qiang Gao, Daohan Zhang, Jiacheng Lu, Yuan Ji, Zhiqiang Hu, Yi Chen and 16 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in The Lancet. Oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07208526 (A Multicenter Randomized Controlled Study on Surgical Decision-Making Guided by the TDTP-RECIST Evaluation System for Locally Advanced Intrahepatic Cholangiocarcinoma Following GOLP Conversion Therapy), which is not on this map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing 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.

NCT07208526 nanot yet recruitingnot on this map

A Multicenter Randomized Controlled Study on Surgical Decision-Making Guided by the TDTP-RECIST Evaluation System for Locally Advanced Intrahepatic Cholangiocarcinoma Following GOLP Conversion Therapy

TypeinterventionalSponsorShanghai Zhongshan HospitalRan2025 to 2028Enrolled270ConditionsIntrahepatic Cholangiocarcinoma (Icc), Conversion Therapy, TDTP-RECIST, GOLP RegimenArmsGOLP regimen, Surgery, TDTP-RECIST
3 · Its place in the literature

Who cites it

19 citing papers in PubMed.

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  7. Advances in Immunotherapy for Intrahepatic Cholangiocarcinoma.International journal of molecular sciences · 2026
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

26 authors.

Guoming ShiDepartment of Hepatobiliary Surgery and Liver Transplantation, Zhongshan Hospital, Fudan University, Shanghai, China; Liver Cancer Institute, Zhongshan Hospital, Fudan University, Shanghai, China; Key Laboratory of Carcinogenesis and Cancer Invasion of Ministry of Education, Shanghai, China; The Longevity and Aging Institute of Fudan University, Shanghai, China.
Xiaoyong HuangDepartment of Hepatobiliary Surgery and Liver Transplantation, Zhongshan Hospital, Fudan University, Shanghai, China.
Xiaowu LiDepartment of Hepatobiliary Surgery, Shenzhen General Hospital of Shenzhen University, Shenzhen, China.
Fei LiangDepartment of Biostatistics, Zhongshan Hospital, Fudan University, Shanghai, China.
Qiang GaoDepartment of Hepatobiliary Surgery and Liver Transplantation, Zhongshan Hospital, Fudan University, Shanghai, China.
Daohan ZhangDepartment of Hepatobiliary Surgery and Liver Transplantation, Zhongshan Hospital, Fudan University, Shanghai, China.
Jiacheng LuDepartment of Hepatobiliary Surgery and Liver Transplantation, Zhongshan Hospital, Fudan University, Shanghai, China.
Yuan JiDepartment of Pathology, Zhongshan Hospital, Fudan University, Shanghai, China.
Zhiqiang HuDepartment of Hepatobiliary Surgery and Liver Transplantation, Zhongshan Hospital, Fudan University, Shanghai, China.
Yi ChenLiver Cancer Institute, Zhongshan Hospital, Fudan University, Shanghai, China; Key Laboratory of Carcinogenesis and Cancer Invasion of Ministry of Education, Shanghai, China.
Shuangjian QiuDepartment of Hepatobiliary Surgery and Liver Transplantation, Zhongshan Hospital, Fudan University, Shanghai, China.
Yong YiDepartment of Hepatobiliary Surgery and Liver Transplantation, Zhongshan Hospital, Fudan University, Shanghai, China.
Xiaodong ZhuDepartment of Hepatobiliary Surgery and Liver Transplantation, Zhongshan Hospital, Fudan University, Shanghai, China.
Huichuan SunDepartment of Hepatobiliary Surgery and Liver Transplantation, Zhongshan Hospital, Fudan University, Shanghai, China.
Yinghong ShiDepartment of Hepatobiliary Surgery and Liver Transplantation, Zhongshan Hospital, Fudan University, Shanghai, China.
MinJie PengDepartment of Hepatobiliary Surgery, Shenzhen General Hospital of Shenzhen University, Shenzhen, China.
Xiaoying WangDepartment of Hepatobiliary Surgery and Liver Transplantation, Zhongshan Hospital, Fudan University, Shanghai, China.
Cheng HuangDepartment of Hepatobiliary Surgery and Liver Transplantation, Zhongshan Hospital, Fudan University, Shanghai, China.
Zhenbin DingDepartment of Hepatobiliary Surgery and Liver Transplantation, Zhongshan Hospital, Fudan University, Shanghai, China.
Yifeng HeDepartment of Hepatobiliary Surgery and Liver Transplantation, Zhongshan Hospital, Fudan University, Shanghai, China.
Yinghao ShenDepartment of Hepatobiliary Surgery and Liver Transplantation, Zhongshan Hospital, Fudan University, Shanghai, China.
Yongfeng XuDepartment of Hepatobiliary Surgery and Liver Transplantation, Zhongshan Hospital, Fudan University, Shanghai, China.
Yongsheng XiaoDepartment of Hepatobiliary Surgery and Liver Transplantation, Zhongshan Hospital, Fudan University, Shanghai, China.
Jie HuDepartment of Hepatobiliary Surgery and Liver Transplantation, Zhongshan Hospital, Fudan University, Shanghai, China.
Jian ZhouDepartment of Hepatobiliary Surgery and Liver Transplantation, Zhongshan Hospital, Fudan University, Shanghai, China; Liver Cancer Institute, Zhongshan Hospital, Fudan University, Shanghai, China; Key Laboratory of Carcinogenesis and Cancer Invasion of Ministry of Education, Shanghai, China.
Jia FanDepartment of Hepatobiliary Surgery and Liver Transplantation, Zhongshan Hospital, Fudan University, Shanghai, China; Liver Cancer Institute, Zhongshan Hospital, Fudan University, Shanghai, China; Key Laboratory of Carcinogenesis and Cancer Invasion of Ministry of Education, Shanghai, China. Electronic address: fan.jia@zs-hospital.sh.cn.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe optimal conversion regimen that allows more patients with unresectable biliary tract cancer to access surgery remains unclear; there is currently no standard conversion therapy for biliary tract cancer in China, with commonly used regimens including immunotherapy-based combinations and local therapy. The ZSAB-TransGOLP study aimed to assess the efficacy and safety of tislelizumab plus lenvatinib and GEMOX (gemcitabine plus oxaliplatin) chemotherapy (GOLP) in patients with this disease.

methodsThis single-arm, phase 2 study was conducted at two centres in China. Eligible patients aged 18-70 years with previously untreated locally advanced unresectable biliary tract cancer (intrahepatic cholangiocarcinoma, perihilar bile duct cancer, and gallbladder cancer), and an Eastern Cooperative Oncology Group performance status of 0 or 1, Child-Pugh score of A, and at least 3 months' life expectancy were enrolled. Patients received 200 mg intravenous tislelizumab on day 1 and intravenous GEMOX (0·5 h of 1000 mg/m

findingsBetween Dec 27, 2021 and July 3, 2023, 52 patients were screened, 11 were excluded for ineligiblity, and 41 patients were enrolled and received the GOLP regimen. All patients were Chinese, with median age of 58 years (IQR 54-65); 21 patients (51%) were male and 20 patients (49%) were female. Median duration of GOLP treatment was 3 cycles (IQR 3-6). 28 (68%) of 41 patients underwent surgery. At a median follow-up of 19·5 months (IQR 14·6-25·0) by data cutoff on Jan 20, 2025, the R0 resection rate was 63% (26 of 41 [95% CI 47-78]). All patients had at least one any-grade treatment-related adverse event (TRAE); grade 3-4 TRAEs occurred in 20 (49%) of 41 patients, with neutropenia (14 [34%] of 41) being most common. Serious TRAEs occurred in 4 (10%) of patients and included neutropenia (three [7%]) and decreased platelet count (one [2%]). No TRAE-related deaths occurred.

interpretationWith promising efficacy and manageable safety, GOLP represents a potentially feasible and high-efficiency conversion regimen for unresectable locally advanced biliary tract cancer.

fundingProgram of Shanghai Academic Research Leader, the Key Disease Joint Research Program of Xuhui District, Shanghai Health Commission Clinical Research Special Project, Fellowship from the China Postdoctoral Science Foundation, National Science and Technology Major Project of China, the Outstanding Resident Clinical Postdoctoral Program of Zhongshan Hospital Affiliated to Fudan University, National Natural Science Foundation of China, and the Shanghai Sailing Program.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiliary Tract NeoplasmsDeoxycytidinePhenylurea CompoundsQuinolinesAdolescentAdultAgedFemaleGemcitabineHumansMaleMiddle AgedOrganoplatinum CompoundsOxaliplatinAntibodies, Monoclonal, HumanizedDeoxycytidineGemcitabinelenvatinibOrganoplatinum CompoundsOxaliplatinPhenylurea CompoundsQuinolinestislelizumab

Identifiers

PMID40889502

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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.