Evidence map›Paper›PMID 36854604›Full record

ArticleBMJ open2023

Afatinib in combination with GEMOX chemotherapy as the adjuvant treatment in patients with ErbB pathway mutated, resectable gallbladder cancer: study protocol for a ctDNA-based, multicentre, open-label, randomised, controlled, phase II trial.

Mao Yang, Yuhao Zhao, Yongsheng Li, Xuya Cui, Fatao Liu, Wenguang Wu, Xu-An Wang, Maolan Li, Yun Liu, Yingbin Liu

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

Article in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04183712 (A Multicentre, Open-label, Randomised, Controlled Study of Target Therapy Based on Tumor Molecular Profiling With GEMOX in Recectable Gallbladder Carcinoma Patients Monitored by ctDNA.), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.3field-weighted citation impact, top 22% 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.

NCT04183712 phase2recruitingnot on this map

A Multicentre, Open-label, Randomised, Controlled Study of Target Therapy Based on Tumor Molecular Profiling With GEMOX in Recectable Gallbladder Carcinoma Patients Monitored by ctDNA.

TypeinterventionalSponsorShanghai Jiao Tong University School of MedicineRan2020 to 2025Enrolled102ConditionsGallbladder CarcinomaArmsgemcitabine and oxaliplatin., Afatinib
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Review
  2. 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

10 authors at 2 institutions in 1 country.

Mao YangDepartment of Biliary-Pancreatic Surgery, Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital, Shanghai, Shanghai, China.
Yuhao ZhaoDepartment of Biliary-Pancreatic Surgery, Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital, Shanghai, Shanghai, China.
Yongsheng LiDepartment of Biliary-Pancreatic Surgery, Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital, Shanghai, Shanghai, China.
Xuya CuiDepartment of Biliary-Pancreatic Surgery, Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital, Shanghai, Shanghai, China.
Fatao LiuState Key Laboratory of Oncogenes and Related Genes, Shanghai Cancer Institute, Shanghai, Shanghai, China.
Wenguang WuDepartment of Biliary-Pancreatic Surgery, Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital, Shanghai, Shanghai, China.
Xu-An WangDepartment of Biliary-Pancreatic Surgery, Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital, Shanghai, Shanghai, China.
Maolan LiDepartment of Biliary-Pancreatic Surgery, Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital, Shanghai, Shanghai, China.
Yun LiuState Key Laboratory of Oncogenes and Related Genes, Shanghai Cancer Institute, Shanghai, Shanghai, China.
Yingbin LiuDepartment of Biliary-Pancreatic Surgery, Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital, Shanghai, Shanghai, China laoniulyb@shsmu.edu.cn.ORCID 0000-0001-6110-0185
Shanghai Jiao Tong University · CNShanghai Cancer Institute · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionGallbladder cancer (GBC) is an aggressive type of digestive system cancer with a dismal outcome. Given the lack of effective treatment options, the disease rapidly reoccurs and 5-year survival rate is <5%. Our team previously found that a significant percentage of GBC tissues harboured mutations of the ErbB-related pathway. Afatinib is a chemically synthesised drug specifically targeting the ErbB pathway mutations. However, its efficacy in the treatment of patients with GBC remains unknown. Circulating tumour DNA (ctDNA) refers to a proportion of cell-free DNA in the blood which is released by apoptotic and necrotic cells from tumours in situ, metastatic foci or circulating tumour cells. ctDNA-based liquid biopsy is a non-invasive pathological detection method that offers additional value to evaluate the therapeutic efficacy of antitumour drugs. METHODS AND ANALYSIS: We conduct a multicentre and randomised study on afatinib combined with gemcitabine and oxaliplatin (GEMOX) in patients with ErbB pathway mutated GBC. Clinical and biological evaluation involving ErbB pathway ctDNA detection will be made during the 3-year follow-up after participation. The primary objective of this clinical trial is to evaluate the clinical efficacy of afatinib. Disease-free survival is the primary end point and will be correlated with plasma ctDNA of patients in the treatment with afatinib. In addition, we will evaluate the sensitivity and specificity of plasma ctDNA for monitoring tumour recurrence and progression. Finally, we will assess the safety of afatinib by keeping an eye on the safety indicators. ETHICS AND DISSEMINATION: The study was approved by the medical-ethical review committee of Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine and Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine. The clinical trials results, even inconclusive, will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04183712.

Indexed as

AfatinibAntineoplastic Combined Chemotherapy ProtocolsCarcinoma in SituGallbladder NeoplasmsAdjuvants, PharmaceuticChinaClinical Trials, Phase II as TopicDeoxycytidineErbB ReceptorsHumansMulticenter Studies as TopicOrganoplatinum CompoundsOxaliplatinRandomized Controlled Trials as TopicAdjuvants, PharmaceuticAfatinibDeoxycytidineErbB ReceptorsOrganoplatinum CompoundsOxaliplatincancer geneticschemotherapygastrointestinal tumourshepatobiliary surgery

Identifiers

PMID36854604
PMCPMC9980349
OpenAlexW4322626113

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.