Evidence map›Paper›PMID 33976538›Full record

Trial reportDrug design, development and therapy2021

Camrelizumab Combined with FOLFOX4 Regimen as First-Line Therapy for Advanced Hepatocellular Carcinomas: A Sub-Cohort of a Multicenter Phase Ib/II Study.

Hui Li, Shukui Qin, Ying Liu, Zhendong Chen, Zhenggang Ren, Jianping Xiong, Zhiqiang Meng, Xiao Zhang, Linna Wang, Xiaojing Zhang and 1 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Drug design, development and therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03092895 (A Phase 2 Study of SHR-1210), which is not on this map. Cited by 24 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 2 pooled it
3.0field-weighted citation impact, top 7% 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.

NCT03092895 phase2completednot on this map

A Phase 2 Study of SHR-1210 (PD-1 Antibody) in Combination With Apatinib or Chemotherapy (FOLFOX4 or GEMOX) in Subjects With Advanced Primary Liver Cancer(PLC)or Biliary Tract Carcinoma (BTC)

TypeinterventionalSponsorJiangsu HengRui Medicine Co., Ltd.Ran2017 to 2021Enrolled157ConditionsAdvanced Primary Liver Cancer, Advanced Biliary Tract CarcinomaArmsSHR-1210, Apatinib, FOLFOX4, GEMOX
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 2 syntheses or guidelines pooled it, 31 citations in OpenAlex.

  1. Pooled it
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  5. Review
  6. Recent Progress in Systemic Therapy for Advanced Hepatocellular Carcinoma.International journal of molecular sciences · 2024
    Review
  7. Hepatocellular Carcinoma: Prevention, Diagnosis, and Treatment.Medical principles and practice : international journal of the Kuwait University, Health Science Centre · 2024
    Review
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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

11 authors at 7 institutions in 1 country.

Hui Li *Department of Medical Oncology Center, Bayi Affiliated Hospital, Nanjing University of Chinese Medicine, Nanjing, People's Republic of China.
Shukui Qin *Department of Medical Oncology Center, Bayi Affiliated Hospital, Nanjing University of Chinese Medicine, Nanjing, People's Republic of China.ORCID 0000-0003-2289-1521
Ying LiuDepartment of Oncology, Cancer Hospital of Henan Province, Zhengzhou, People's Republic of China.ORCID 0000-0002-8859-9585
Zhendong ChenDepartment of Clinical Oncology, The Second Affiliated Hospital of Anhui Medical University, Hefei, People's Republic of China.
Zhenggang RenDepartment of Clinical Oncology, Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China.
Jianping XiongDepartment of Clinical Oncology, The First Affiliated Hospital of Nanchang University, Nanchang, People's Republic of China.
Zhiqiang MengMinimally Invasive Treatment Center, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China.
Xiao ZhangJiangsu Hengrui Medicine Co., Ltd, Shanghai, People's Republic of China.
Linna WangJiangsu Hengrui Medicine Co., Ltd, Shanghai, People's Republic of China.
Xiaojing ZhangJiangsu Hengrui Medicine Co., Ltd, Shanghai, People's Republic of China.
Jianjun ZouJiangsu Hengrui Medicine Co., Ltd, Shanghai, People's Republic of China.
Jiangsu Hengrui Medicine (China) · CNNanjing University of Chinese Medicine · CNAnhui Medical University · CNFudan University Shanghai Cancer Center · CNHenan Cancer Hospital · CNNanchang University · CNSun Yat-sen University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundImmune checkpoint inhibitors and chemotherapy can synergistically increase efficacy in a variety of malignancies. We conducted this phase Ib/II study to assess the safety and efficacy of anti-PD-1 antibody camrelizumab in combination with FOLFOX4 for treatment-naive advanced hepatocellular carcinoma (aHCC).

methodsThis open-label, multicenter phase Ib/II study (NCT03092895) enrolled patients with aHCC and without prior systemic treatment for treatment with camrelizumab (3 mg/kg) and FOLFOX4 every two weeks. First, six patients were enrolled, followed by an additional 28 patients after dose-limiting toxicity cases were determined to be <33% of patients. The primary endpoint was tolerability and safety of treatment.

resultsA total of 34 aHCC patients were enrolled and received study treatment. No dose-limiting toxicity were observed in the first six patients enrolled. Twenty-nine (85.3%) of the total 34 patients had grade ≥3 treatment-related adverse events (TRAEs), with the most common ones being decreased neutrophil count (55.9%) and decreased white blood cell count (38.2%). No TRAEs-related deaths occurred. The objective response and disease control rate were 29.4% (95% CI, 15.1-47.5) and 79.4% (95% CI, 62.1-91.3), respectively. The median duration of response, progression-free survival, and overall survival was 6.9 months (range, 3.3-11.5), 7.4 months (95% CI, 3.9-9.2), and 11.7 months (95% CI, 8.2-22.0), respectively.

conclusionCamrelizumab combined with FOLFOX4 for first-line treatment of patients with aHCC showed good safety and tolerability, with promising preliminary antitumor activity.

Indexed as

AdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, HepatocellularFemaleFluorouracilHumansLeucovorinLiver NeoplasmsMaleMiddle AgedOrganoplatinum CompoundsAntibodies, Monoclonal, HumanizedcamrelizumabFluorouracilLeucovorinOrganoplatinum Compoundscamrelizumabcombination therapyFOLFOX4 regimenhepatocellular carcinomaPD-1 monoclonal antibody

Identifiers

PMID33976538
PMCPMC8106453
OpenAlexW3158336361

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.