Evidence map›Paper›PMID 40835595›Full record

Trial reportSignal transduction and targeted therapy2025

First-line tislelizumab and ociperlimab combined with gemcitabine and cisplatin in advanced biliary tract cancer (ZSAB-TOP): a multicenter, single-arm, phase 2 study.

Guoming Shi, Xiaoyong Huang, Liang Ma, Hui Li, Jianhong Zhong, Junye Wang, Qiang Gao, Xiaojun Guo, Shuangjian Qiu, Huichuan Sun and 13 more

Registry-linked trialAbstract readMulticenter StudyClinical Trial, Phase II
In one paragraph

Trial report in Signal transduction and targeted therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05023109 (A Study to Evaluate GP Chemotherapy in Combination With Tislelizumab and Ociperlimab as First-line Treatment in Participants With Unresectable Advanced Biliary Tract Carcinoma), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing 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.

NCT05023109 phase2unknown statusnot on this map

A Study to Evaluate GP Chemotherapy in Combination With Tislelizumab and Ociperlimab as First-line Treatment in Participants With Unresectable Advanced Biliary Tract Carcinoma (BTC)

TypeinterventionalSponsorShanghai Zhongshan HospitalRan2021 to 2024Enrolled45ConditionsBiliary Tract CarcinomaArmsGP+PD-1+Tight
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. CD112 Lactylation Drives Dual Immune Evasion From CD8+ T Cells and NK Cells.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026
    Article
  4. Restoring the CD226 in CD8Cell death & disease · 2026
    Article
  5. Review
  6. Article
  7. Multimodal cell-cell communication driving CD8Frontiers in immunology · 2025
    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

23 authors.

Guoming Shi *Department of Hepatobiliary Surgery and Liver Transplantation, Liver Cancer Institute, Zhongshan Hospital, Fudan University, Key Laboratory of Carcinogenesis and Cancer Invasion of Ministry of Education, Shanghai, 200032, China. shi.guoming@zs-hospital.sh.cn.
Xiaoyong Huang *Department of Hepatobiliary Surgery and Liver Transplantation, Liver Cancer Institute, Zhongshan Hospital, Fudan University, Key Laboratory of Carcinogenesis and Cancer Invasion of Ministry of Education, Shanghai, 200032, China.
Liang Ma *Department of Hepatobiliary Surgery, Guangxi Medical University Cancer Hospital, Nanning, Guangxi, 530021, China.
Hui Li *Department of Oncology, The Affiliated Hospital of Jining Medical University, Jining, 272000, China.
Jianhong ZhongDepartment of Hepatobiliary Surgery, Guangxi Medical University Cancer Hospital, Nanning, Guangxi, 530021, China.ORCID 0000-0002-1494-6396
Junye WangDepartment of Oncology, The Affiliated Hospital of Jining Medical University, Jining, 272000, China.
Qiang GaoDepartment of Hepatobiliary Surgery and Liver Transplantation, Liver Cancer Institute, Zhongshan Hospital, Fudan University, Key Laboratory of Carcinogenesis and Cancer Invasion of Ministry of Education, Shanghai, 200032, China.
Xiaojun GuoDepartment of Hepatobiliary Surgery and Liver Transplantation, Liver Cancer Institute, Zhongshan Hospital, Fudan University, Key Laboratory of Carcinogenesis and Cancer Invasion of Ministry of Education, Shanghai, 200032, China.
Shuangjian QiuDepartment of Hepatobiliary Surgery and Liver Transplantation, Liver Cancer Institute, Zhongshan Hospital, Fudan University, Key Laboratory of Carcinogenesis and Cancer Invasion of Ministry of Education, Shanghai, 200032, China.
Huichuan SunDepartment of Hepatobiliary Surgery and Liver Transplantation, Liver Cancer Institute, Zhongshan Hospital, Fudan University, Key Laboratory of Carcinogenesis and Cancer Invasion of Ministry of Education, Shanghai, 200032, China.
Yinghong ShiDepartment of Hepatobiliary Surgery and Liver Transplantation, Liver Cancer Institute, Zhongshan Hospital, Fudan University, Key Laboratory of Carcinogenesis and Cancer Invasion of Ministry of Education, Shanghai, 200032, China.
Xiaowu HuangDepartment of Hepatobiliary Surgery and Liver Transplantation, Liver Cancer Institute, Zhongshan Hospital, Fudan University, Key Laboratory of Carcinogenesis and Cancer Invasion of Ministry of Education, Shanghai, 200032, China.
Xiaoying WangDepartment of Hepatobiliary Surgery and Liver Transplantation, Liver Cancer Institute, Zhongshan Hospital, Fudan University, Key Laboratory of Carcinogenesis and Cancer Invasion of Ministry of Education, Shanghai, 200032, China.
Yong YiDepartment of Hepatobiliary Surgery and Liver Transplantation, Liver Cancer Institute, Zhongshan Hospital, Fudan University, Key Laboratory of Carcinogenesis and Cancer Invasion of Ministry of Education, Shanghai, 200032, China.
Xiaodong ZhuDepartment of Hepatobiliary Surgery and Liver Transplantation, Liver Cancer Institute, Zhongshan Hospital, Fudan University, Key Laboratory of Carcinogenesis and Cancer Invasion of Ministry of Education, Shanghai, 200032, China.
Cheng HuangDepartment of Hepatobiliary Surgery and Liver Transplantation, Liver Cancer Institute, Zhongshan Hospital, Fudan University, Key Laboratory of Carcinogenesis and Cancer Invasion of Ministry of Education, Shanghai, 200032, China.
Zhenbin DingDepartment of Hepatobiliary Surgery and Liver Transplantation, Liver Cancer Institute, Zhongshan Hospital, Fudan University, Key Laboratory of Carcinogenesis and Cancer Invasion of Ministry of Education, Shanghai, 200032, China.ORCID 0000-0001-6613-8270
Yi ChenDepartment of Hepatic Oncology, Liver Cancer Institute, Zhongshan Hospital, Fudan University, Key Laboratory of Carcinogenesis and Cancer Invasion of Ministry of Education, Shanghai, 200032, China.
Yifeng HeDepartment of Hepatobiliary Surgery and Liver Transplantation, Liver Cancer Institute, Zhongshan Hospital, Fudan University, Key Laboratory of Carcinogenesis and Cancer Invasion of Ministry of Education, Shanghai, 200032, China.
Yinghao ShenDepartment of Hepatobiliary Surgery and Liver Transplantation, Liver Cancer Institute, Zhongshan Hospital, Fudan University, Key Laboratory of Carcinogenesis and Cancer Invasion of Ministry of Education, Shanghai, 200032, China.
Qiman SunDepartment of Hepatobiliary Surgery and Liver Transplantation, Liver Cancer Institute, Zhongshan Hospital, Fudan University, Key Laboratory of Carcinogenesis and Cancer Invasion of Ministry of Education, Shanghai, 200032, China.
Jian ZhouDepartment of Hepatobiliary Surgery and Liver Transplantation, Liver Cancer Institute, Zhongshan Hospital, Fudan University, Key Laboratory of Carcinogenesis and Cancer Invasion of Ministry of Education, Shanghai, 200032, China. zhou.jian@zs-hospital.sh.cn.ORCID 0000-0002-2118-1117
Jia FanDepartment of Hepatobiliary Surgery and Liver Transplantation, Liver Cancer Institute, Zhongshan Hospital, Fudan University, Key Laboratory of Carcinogenesis and Cancer Invasion of Ministry of Education, Shanghai, 200032, China. fan.jia@zs-hospital.sh.cn.ORCID 0000-0001-5158-629X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Adding a PD-1/PD-L1 inhibitor to gemcitabine plus cisplatin (GemCis) has shown survival benefits in advanced biliary tract cancer (BTC). Dual inhibition of PD-1/PD-L1 and TIGIT may act synergistically, and further enhance antitumor effects. ZSAB-TOP was a single-arm, multicenter, phase 2 study (NCT05023109) evaluating efficacy and safety of first-line tislelizumab (a PD-1 inhibitor) plus ociperlimab (a TIGIT inhibitor) and GemCis in advanced BTC. Eligible patients received tislelizumab (200 mg) and ociperlimab (900 mg) on day 1 until unacceptable toxicity or disease progression, in combination with cisplatin (25 mg/m²) and gemcitabine (1000 mg/m²) on days 1 and 8 of a 21-day cycle for a maximum eight cycles. The primary endpoint was confirmed objective response rate (ORR) evaluated by the investigator, which was compared with a historical ORR of 25% with GemCis, with a statistical superiority setting at p ≤ 0.05. From March 8, 2022, to January 18, 2023, 45 patients were enrolled. Among the 41 patients in the efficacy analysis set, the confirmed ORR was 51.2% (95% CI 35.1-67.1), achieving the statistical superiority criteria (p = 0.0003). Patients who had TIGIT

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiliary Tract NeoplasmsDeoxycytidineAdultAgedCisplatinFemaleGemcitabineHumansMaleMiddle AgedReceptors, ImmunologicAntibodies, Monoclonal, HumanizedCisplatinDeoxycytidineGemcitabineReceptors, ImmunologicTIGIT protein, humantislelizumab

Identifiers

PMID40835595
PMCPMC12368246

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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.