Evidence map›Paper›PMID 32646394›Full record

ArticleBMC cancer2020

Study protocol for an open-label, single-arm, phase Ib/II study of combination of toripalimab, nab-paclitaxel, and gemcitabine as the first-line treatment for patients with unresectable pancreatic ductal adenocarcinoma.

Lin Shui, Ke Cheng, Xiaofen Li, Pixian Shui, Xiaohan Zhou, Jian Li, Cheng Yi, Dan Cao

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

Article in BMC 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 NCT05173246 (JS001 Combined With Nab-paclitaxel and Cisplatin or Carboplatin as First-line Treatment for Unresectable or Advanced Small Cell Esophageal Carcinoma), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
0.7field-weighted citation impact, top 28% 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.

NCT05173246 phase2recruitingnot on this map

JS001 Combined With Nab-paclitaxel and Cisplatin or Carboplatin as First-line Treatment for Unresectable or Advanced Small Cell Esophageal Carcinoma : a Prospective, Single Arm, Multicenter, Phase II Clinical Trial

TypeinterventionalSponsorSun Yat-sen UniversityRan2020 to 2026Enrolled43ConditionsEsophageal Small Cell CarcinomaArmsJS001, nab-paclitaxel, Cisplatin, Carboplatin
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 16 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Updates in Immunotherapy for Pancreatic Cancer.Journal of clinical medicine · 2024
    Review
  6. Article
  7. Review
  8. Article
  9. Article
  10. Article
  11. Combination therapy for pancreatic cancer: anti-PD-(L)1-based strategy.Journal of experimental & clinical cancer research : CR · 2022
    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

8 authors at 2 institutions in 1 country.

Lin ShuiDepartment of Abdominal Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu, China.
Ke ChengDepartment of Abdominal Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu, China.
Xiaofen LiDepartment of Abdominal Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu, China.
Pixian ShuiSchool of Pharmacy, Southwest Medical University, Luzhou, China.
Xiaohan ZhouDepartment of Abdominal Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu, China.
Jian LiDepartment of Pharmacy, The Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University, Luzhou, China.
Cheng YiDepartment of Abdominal Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu, China.
Dan CaoDepartment of Abdominal Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu, China. hxcaodan2019@163.com.
Sichuan University · CNSouthwest Medical University · CN

Funding

National Natural Science Foundation of China 81773097
6 · The paper itself

Abstract

backgroundPancreatic ductal adenocarcinoma (PDAC) is a fatal disease with a dismal response to single-use of immune checkpoint inhibitors (ICIs). ICIs combined with systemic therapy has shown efficacy and safety in various solid tumors. Nab-paclitaxel and gemcitabine (AG), as the standard first-line treatment for advanced PDAC, has been widely used in recent years. The combination of ICIs and AG chemotherapy appears to be a promising option in the treatment of PDAC.

methodsThis is an open-label, single-arm, and single-center phase Ib/II trial. The enrolled subjects are the unresectable (locally advanced or metastatic) PDAC patients without previous systemic treatments. All subjects receive an intravenous injection of gemcitabine 1000 mg/m DISCUSSION: This trial is the first attempt to evaluate the efficacy and safety of the combination of toripalimab plus AG chemotherapy as a first-line treatment for unresectable PDAC patients. The results of this phase Ib/II study will provide preliminary evidence for further assessment of this combined therapeutic regimen for unresectable PDAC patients.

trial registrationTrial registration: ChiCTR ( ChiCTR2000032293 ). Registered 25 April 2020 - Retrospectively registered.

Indexed as

Research DesignAdolescentAdultAgedAged, 80 and overAlbuminsAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Pancreatic DuctalClinical Trials, Phase I as TopicClinical Trials, Phase II as TopicDeoxycytidineFemaleFollow-Up StudiesGemcitabineHumans130-nm albumin-bound paclitaxelAlbuminsAntibodies, Monoclonal, HumanizedDeoxycytidineGemcitabinePaclitaxeltoripalimabClinical protocolCombination therapyPancreatic ductal adenocarcinomaPD-1 blockade

Identifiers

PMID32646394
PMCPMC7346390
OpenAlexW3041890029

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.