Evidence map›Paper›PMID 42176183›Full record

Trial reportAdvances in therapy2026

First-Line Pembrolizumab Plus Chemotherapy for Advanced Biliary Tract Cancer: China Subgroup Analysis of the Randomized Phase 3 KEYNOTE-966 Study.

Zhenggang Ren, Tingbo Liang, Shanzhi Gu, Hongfeng Gou, Chuang Peng, Yueyin Pan, Tianqiang Song, Haichuan Su, Ke Cao, Houjie Liang and 14 more

2 registry-linked trialsAbstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Advances in therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

NCT04003636 phase3completednot on this map

A Phase 3 Randomized, Double Blind Study of Pembrolizumab Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin as First-Line Therapy in Participants With Advanced and/or Unresectable Biliary Tract Carcinoma

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2019 to 2025Enrolled1,069ConditionsBiliary Tract CarcinomaArmsPembrolizumab, Gemcitabine, Cisplatin, Placebo
NCT04924062 phase3completednot on this map

A Phase 3 Randomized, Double Blind Study of Pembrolizumab Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin as First-Line Therapy in Participants With Advanced and/or Unresectable Biliary Tract Carcinoma

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2020 to 2025Enrolled158ConditionsBiliary Tract CarcinomaArmsPembrolizumab, Gemcitabine, Cisplatin, Placebo
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

24 authors.

Zhenggang RenDepartment of Hepatic Oncology, Liver Cancer Institute, Zhongshan Hospital, Fudan University, National Clinical Research Center for Interventional Medicine, Shanghai, China.
Tingbo LiangDepartment of Hepatobiliary and Pancreatic Surgery, The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.
Shanzhi GuDepartment of Interventional Therapy, Hunan Cancer Hospital, Changsha, China.
Hongfeng GouDepartment of Medical Oncology, West China Hospital of Sichuan University, Sichuan, China.
Chuang PengDepartment of Hepatobiliary Surgery, Hunan Provincial People's Hospital, Changsha, China.
Yueyin PanDepartment of Tumor Biotherapy (5th Ward of the Department of Oncology), Anhui Provincial Hospital, Anhui, China.
Tianqiang SongLiver Cancer Center, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin Clinical Research Center for Cancer, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.
Haichuan SuDepartment of Oncology, Tangdu Hospital, Shaanxi, China.
Ke CaoDepartment of Oncology, The Third Xiangya Hospital of Central South University, Changsha, China.
Houjie LiangDepartment of Oncology and Southwest Cancer Center, First Affiliated Hospital of The Third Military Medical University, Chongqing, China.
Jieer YingDepartment of Hepato-Pancreato-Biliary and Gastric Medical Oncology, Zhejiang Cancer Hospital, Hangzhou, China.
Zhimin GengDepartment of Hepatobiliary Surgery, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
Wenchang YuDepartment of Interventional Oncology, Fujian Provincial Cancer Hospital, Fujian, China.
Haitao ZhaoDepartment of Liver Surgery, Peking Union Medical College Hospital, Beijing, China.
Yuxian BaiDepartment of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China.
Chunyi HaoDepartment of Hepato-Pancreato-Biliary Surgery, Beijing Cancer Hospital, Beijing, China.
Yimin MaoDivision of Gastroenterology and Hepatology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, NHC Key Laboratory of Digestive Diseases, Shanghai Research Center of Fatty Liver Disease, Shanghai, China.
Wei LiDepartment of Gastroenterology, The First Hospital of Jilin University, Changchun, China.
Lu WangDepartment of Hepatic Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.
Dongliang LiDepartment of Hepatobiliary Disease, The 900th Hospital of the Joint Logistics Support Force, PLA, Fuzhou, China.
Wenmiao WangDepartment of Medical Oncology, MSD China, Beijing, China.
Nan LiDepartment of Medical Oncology, MSD China, Beijing, China.
Usha MalhotraGlobal Clinical Development, Merck & Co., Inc., Rahway, NJ, USA.
Shukui QinGI Cancer Center, Nanjing Tianyinshan Hospital of China Pharmaceutical University, Nanjing, China. qinsk@csco.org.cn.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIn the global phase 3 KEYNOTE-966 study (NCT04003636), pembrolizumab plus gemcitabine and cisplatin (pembrolizumab group) showed a statistically significant, clinically meaningful improvement in overall survival (OS) versus placebo plus gemcitabine and cisplatin (placebo group) without any new safety signals in participants with advanced biliary tract cancer (BTC). This analysis focused on the subgroup of participants from KEYNOTE-966 enrolled in China.

methodsAdults with previously untreated advanced BTC were randomly assigned (1:1) to receive pembrolizumab 200 mg or placebo intravenously every 3 weeks plus gemcitabine 1000 mg/m

resultsOne hundred fifty-eight participants were enrolled in China (75, pembrolizumab group; 83, placebo group). Median time from randomization to data cutoff (December 15, 2022) was 20.5 (range, 15.0-28.8) months. Median OS was 14.1 (95% CI, 10.4-17.7) months in the pembrolizumab group versus 9.9 (95% CI, 8.6-13.0) months in the placebo group (HR, 0.74; 95% CI, 0.51-1.08); median PFS was 5.6 (95% CI, 3.2-7.4) months versus 5.7 (95% CI, 4.4-6.9; HR, 0.83 [95% CI, 0.58-1.19]) months; ORR was 36.0% (95% CI, 25.2-47.9) versus 28.9% (95% CI, 19.5-39.9); median DOR was 10.2 (range, 1.2+ to 20.6) months versus 5.7 (range, 1.4+ to 18.2) months. Grade 3 or 4 treatment-related adverse events occurred in 53 participants (71.6%) in the pembrolizumab group versus 58 (70.7%) in the placebo group; no treatment-related grade 5 events occurred.

conclusionConsistent with the KEYNOTE-966 global population, first-line pembrolizumab plus gemcitabine and cisplatin provided a numeric improvement in OS versus placebo plus gemcitabine and cisplatin and no new safety signals in participants enrolled in China.

trial registrationClinicalTrials.gov identifiers: NCT04003636, NCT04924062.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiliary Tract NeoplasmsAdultAgedChinaCisplatinDeoxycytidineFemaleGemcitabineHumansMaleMiddle AgedProgression-Free SurvivalAntibodies, Monoclonal, HumanizedCisplatinDeoxycytidineGemcitabinepembrolizumabBiliary tract cancerChemotherapyChinaPembrolizumab

Identifiers

PMID42176183

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.