Evidence map›Paper›PMID 33172881›Full record

Trial reportJournal for immunotherapy of cancer2020

Camrelizumab plus gemcitabine and oxaliplatin (GEMOX) in patients with advanced biliary tract cancer: a single-arm, open-label, phase II trial.

Xiaofeng Chen, Xiaofeng Wu, Hao Wu, Yanhong Gu, Yang Shao, Qianwen Shao, Feipeng Zhu, Xiao Li, Xiaofeng Qian, Jun Hu and 15 more

4 registry-linked trialsAbstract readClinical Trial, Phase II
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 4 registered trials, which are not on this map. Cited by 119 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
119citing papers in PubMed, 6 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.

NCT03486678 phase2completednot on this map

A Single-arm, Open-label and Exploratory Clinical Study of PD-1 Monoclonal Antibody SHR-1210 in Combination With GEMOX (Gemcitabine Combined Oxaliplatin) in Patients With Advanced Biliary Tract Cancer

TypeinterventionalSponsorThe First Affiliated Hospital with Nanjing Medical UniversityRan2018 to 2020Enrolled38ConditionsBiliary Tract Cancer, CholangiocarcinomaArmsSHR-1210+GEMOX
NCT04720131 phase2completednot on this mapstarted 2021, after this paper: background citation

Camrelizumab Combined With Apatinib and Capecitabine for Patients With Advanced Biliary Tract Cancer: a Phase 2, Single-arm, Prospective Study.

TypeinterventionalSponsorBeijing Friendship HospitalRan2021 to 2023Enrolled28ConditionsBiliary Tract Cancer, Anti-PD-1 Therapy, Targeted Molecular Therapy, CapecitabineArmsCamrelizumab, apatinib, Capecitabine
NCT05430698 phase2recruitingnot on this mapstarted 2023, after this paper: background citation

PD-1 Antibody Plus Gemcitabine and Oxaliplatin (GEMOX) as Postoperative Adjuvant Therapy in Perihilar Cholangiocarcinoma Patients With Positively Metastatic Lymph Nodes : a Single Arm, Phase II Trial

TypeinterventionalSponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRan2023 to 2027Enrolled62ConditionsPerihilar CholangiocarcinomaArmsPD-1antibody plus GEMOX
NCT05919095 phase2unknown statusnot on this mapstarted 2023, after this paper: background citation

A Single-arm, Multicenter, Phase II Clinical Study of the Efficacy and Safety of Carrilizumab Combinated With Gemcitabine and Oxaliplatin (GEMOX) as a Preoperative Translational Therapy for Unresectable Gallbladder Cancer

TypeinterventionalSponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRan2023 to 2026Enrolled37ConditionsUnresectable Gallbladder CancerArmsCarrilizumab plus GEMOX
3 · Its place in the literature

Who cites it

119 citing papers in PubMed, 6 syntheses or guidelines pooled it.

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59 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

25 authors.

Xiaofeng ChenDepartment of Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Xiaofeng WuHepatobiliary Center, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Hao WuDepartment of Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Yanhong GuDepartment of Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Yang ShaoMedical Department, Nanjing Geneseeq Technology Inc, Nanjing, China.
Qianwen ShaoDepartment of Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Feipeng ZhuDepartment of Radiology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Xiao LiDepartment of Pathology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Xiaofeng QianHepatobiliary Center, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Jun HuDepartment of Oncology, Nanjing Red Cross Hospital, Nanjing, China.
Fengjiao ZhaoDepartment of Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Weidong MaoDepartment of Oncology, Jiangyin People's Hospital, Jiangyin, China.
Jing SunDepartment of Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Jian WangDepartment of Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Gaohua HanDepartment of Oncology, Taizhou People's Hospital Affiliated to Nantong University, Taizhou, China.
Changxian LiHepatobiliary Center, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Yongxiang XiaHepatobiliary Center, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Poshita Kumari SeesahaDepartment of Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Dongqin ZhuMedical Department, Nanjing Geneseeq Technology Inc, Nanjing, China.
Huajun LiMedical Department, Jiangsu Hengrui Medicine Co Ltd, Lianyungang, China.
Junling ZhangMedical Department, 3D Medicines Inc, Shanghai, China.
Guoqiang WangMedical Department, Burning Rock Biotech, Guangzhou, China.
Xuehao WangHepatobiliary Center, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Xiangcheng LiHepatobiliary Center, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Yongqian ShuDepartment of Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China shuyongqian@csco.org.cn.ORCID 0000-0003-2103-0877

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundImmune checkpoint inhibitors monotherapy has been studied in patients with advanced biliary tract cancer (BTC). The aim of this study was to assess the efficacy and safety of camrelizumab, plus gemcitabine and oxaliplatin (GEMOX) as first-line treatment in advanced BTC and explored the potential biomarkers associated with response.

methodsIn this single-arm, open-label, phase II study, we enrolled stage IV BTC patients. Participants received camrelizumab (3 mg/kg) plus gemcitabine (800 mg/m

results54 patients with advanced BTC were screened, of whom 38 eligible patients were enrolled. One patient withdrew informed consent before first dose treatment. Median follow-up was 11.8 months. The 6-month PFS rate was 50% (95% CI 33 to 65). Twenty (54%) out of 37 patients had an objective response. The median PFS was 6.1 months and median OS was 11.8 months. The most common treatment-related adverse events (TRAEs) were fatigue (27 (73%)) and fever (27 (73%)). The most frequent grade 3 or worse TRAEs were hypokalemia (7 (19%)) and fatigue (6 (16%)). The ORR was 80% in patients with programmed cell death ligand-1 (PD-L1) tumor proportion score (TPS) ≥1% versus 53.8% in PD-L1 TPS <1%. There was no association between response and TMB, blood TMB, immune proportion score or immune cells (p>0.05), except that PFS was associated with blood TMB. Patients with positive post-treatment ctDNA had shorter PFS (p=0.007; HR, 2.83; 95% CI 1.27 to 6.28).

conclusionCamrelizumab plus GEMOX showed a promising antitumor activity and acceptable safety profile as first-line treatment in advanced BTC patients. Potential biomarkers are needed to identify patients who might respond to camrelizumab plus GEMOX. TRIAL REGISTRATION NUMBER: NCT03486678.

Indexed as

AdolescentAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBile Duct NeoplasmsDeoxycytidineFemaleGemcitabineHumansMaleMiddle AgedOxaliplatinYoung AdultAntibodies, Monoclonal, HumanizedcamrelizumabDeoxycytidineGemcitabineOxaliplatinbiomarkersclinical trialsimmunotherapyphase II as topictumor

Identifiers

PMID33172881
PMCPMC7656907

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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.