Evidence map›Paper›PMID 32487569›Full record

Trial reportJournal for immunotherapy of cancer2020

Efficacy and biomarker analysis of nivolumab plus gemcitabine and cisplatin in patients with unresectable or metastatic biliary tract cancers: results from a phase II study.

Kaichao Feng, Yang Liu, Yongtian Zhao, Qingming Yang, Liang Dong, Jiejie Liu, Xiang Li, Zhikun Zhao, Qian Mei, Weidong Han

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal for immunotherapy of cancer, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03311789 (A Pilot Study of PD-1 Inhibitor in Combination With Gemcitabine/Cisplatin for Patients With Advanced Unresectable or Metastatic Biliary Tract Cancers), which is not on this map. Cited by 76 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
76citing papers in PubMed, 6 pooled it
14.5field-weighted citation impact, top 1% of its field
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.

NCT03311789 phase1 / phase2unknown statusnot on this map

A Pilot Study of PD-1 Inhibitor in Combination With Gemcitabine/Cisplatin for Patients With Advanced Unresectable or Metastatic Biliary Tract Cancers

TypeinterventionalSponsorChinese PLA General HospitalRan2017 to 2019Enrolled30ConditionsBiliary Tract CancerArmsPD-1 inhibitor + Gemcitabine + Cisplatin
3 · Its place in the literature

Who cites it

76 citing papers in PubMed, 6 syntheses or guidelines pooled it, 107 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Review
  12. Review
  13. Review
  14. Article
  15. Review
  16. Review
  17. Review
  18. Article
  19. Review
  20. Review

16 more citing papers are in PubMed but not listed here.

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

10 authors at 1 institution in 1 country.

Kaichao Feng *Department of Bio-therapeutic, the First Medical Center, Chinese PLA General Hospital, Beijing, China.
Yang Liu *Department of Bio-therapeutic, the First Medical Center, Chinese PLA General Hospital, Beijing, China.
Yongtian Zhao *YuceBio Technology Co., Ltd, Shenzhen, China.
Qingming YangDepartment of Bio-therapeutic, the First Medical Center, Chinese PLA General Hospital, Beijing, China.
Liang DongDepartment of Bio-therapeutic, the First Medical Center, Chinese PLA General Hospital, Beijing, China.
Jiejie LiuDepartment of Bio-therapeutic, the First Medical Center, Chinese PLA General Hospital, Beijing, China.
Xiang LiDepartment of Bio-therapeutic, the First Medical Center, Chinese PLA General Hospital, Beijing, China.
Zhikun ZhaoYuceBio Technology Co., Ltd, Shenzhen, China.
Qian MeiDepartment of Bio-therapeutic, the First Medical Center, Chinese PLA General Hospital, Beijing, China hanwdrsw69@yahoo.com meiqnn@hotmail.com.
Weidong HanDepartment of Bio-therapeutic, the First Medical Center, Chinese PLA General Hospital, Beijing, China hanwdrsw69@yahoo.com meiqnn@hotmail.com.ORCID 0000-0003-3207-3899
Chinese PLA General Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe prognosis of patients with unresectable or metastatic biliary tract cancer (BTC) is unacceptably low. This study aimed to determine the efficacy, safety and predictive biomarkers of the immune checkpoint inhibitor nivolumab in combination with chemotherapy in advanced BTCs.

methodsIn this open-label, single-arm, phase II trial, a chemotherapy and immunotherapy combination consisting of gemcitabine 1000 mg/m

resultsThirty-two patients with a median age of 60 (range 27-69) years were enrolled. As of September 31, 2019, the median follow-up was 12.8 (95% CI 10.8 to 14.8) months. Twenty-seven response-evaluable patients received a median of 4 (IQR, 3-6) cycles of combination therapy, of whom 15 (55.6%) patients achieved an objective response, including 5 (18.6%) with a complete response (CR), and the DCR was 92.6%. Of the six patients in cohort A who were resistant to gemcitabine-based or cisplatin-based chemotherapy, one achieved CR and one achieved partial response. Thirteen of 21 chemotherapy-naive patients (61.9%) in cohort B achieved an objective response. The median PFS of all patients in cohorts A+B was 6.1 months. The median OS was 8.5 months, with a 33.3% 12-month OS rate. The most frequent grade 3 or higher adverse events were thrombocytopenia (56%) and neutropenia (22%). Fitness might be a biomarker for predicting clinical response. On-therapy changes in serum soluble FasL, MCP-1 and interferon-γ were correlated with prognosis.

conclusionsNivolumab in combination with gemcitabine and cisplatin offers promising efficacy and a manageable safety profile for patients with advanced BTCs. TRIAL REGISTRATION NUMBER: NCT03311789.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBiliary Tract NeoplasmsBiomarkers, TumorCisplatinDeoxycytidineDrug MonitoringFemaleGemcitabineHumansMaleMiddle AgedNeutropeniaNivolumabPilot ProjectsBiomarkers, TumorCisplatinDeoxycytidineGemcitabineNivolumabimmunologyoncology

Identifiers

PMID32487569
PMCPMC7269541
OpenAlexW3030632902

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.