Evidence map›Paper›PMID 35712486›Full record

ArticleFrontiers in oncology2022

Safety and Efficacy of Sintilimab and Anlotinib as First Line Treatment for Advanced Hepatocellular Carcinoma (KEEP-G04): A Single-Arm Phase 2 Study.

Xiaofeng Chen, Wei Li, Xiaofeng Wu, Fengjiao Zhao, Deqiang Wang, Hao Wu, Yanhong Gu, Xiao Li, Xiaofeng Qian, Jun Hu and 8 more

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

Article in Frontiers in oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04052152 (Anlotinib Hydrochloride Capsules Combined With Sintilimab Injection in the Treatment of Advanced Hepatocellular Carcinoma), which is not on this map. Cited by 38 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 5 pooled it
6.6field-weighted citation impact, top 2% 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.

NCT04052152 phase2unknown statusnot on this map

Anlotinib Hydrochloride Capsules Combined With Sintilimab Injection in the Treatment of Advanced Hepatocellular Carcinoma (HCC) Open, Single Arm, Exploratory Clinical Trial

TypeinterventionalSponsorThe First Affiliated Hospital with Nanjing Medical UniversityRan2019 to 2021Enrolled20ConditionsAdvanced Hepatocellular CarcinomaArmsAnlotinib and Sintilimab injection
3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 5 syntheses or guidelines pooled it, 47 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Trial
  7. Trial
  8. Article
  9. Review
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Review
  17. Review
  18. Review
  19. The causality between CD8Infectious agents and cancer · 2024
    Article
  20. Article
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

18 authors at 5 institutions in 1 country.

Xiaofeng ChenDepartment of Oncology, Jiangsu Province Hospital, The First Affiliated Hospital, Nanjing Medical University, Nanjing, China.
Wei LiDepartment of Oncology, The First Affiliated Hospital, Soochow University, Suzhou, China.
Xiaofeng WuHepatobiliary Center, Jiangsu Province Hospital, The First Affiliated Hospital, Nanjing Medical University, Nanjing, China.
Fengjiao ZhaoDepartment of Oncology, Huai'an Second People's Hospital, The Affiliated Huai'an Hospital, Xuzhou Medical University, Huai'an, China.
Deqiang WangDepartment of Oncology, Affiliated Hospital of Jiangsu University, Zhenjiang, China.
Hao WuDepartment of Oncology, Jiangsu Province Hospital, The First Affiliated Hospital, Nanjing Medical University, Nanjing, China.
Yanhong GuDepartment of Oncology, Jiangsu Province Hospital, The First Affiliated Hospital, Nanjing Medical University, Nanjing, China.
Xiao LiDepartment of Pathology, Jiangsu Province Hospital, The First Affiliated Hospital, Nanjing Medical University, Nanjing, China.
Xiaofeng QianHepatobiliary Center, Jiangsu Province Hospital, The First Affiliated Hospital, Nanjing Medical University, Nanjing, China.
Jun HuDepartment of Oncology, Nanjing Red Cross Hospital, Nanjing, China.
Changxian LiHepatobiliary Center, Jiangsu Province Hospital, The First Affiliated Hospital, Nanjing Medical University, Nanjing, China.
Yongxiang XiaHepatobiliary Center, Jiangsu Province Hospital, The First Affiliated Hospital, Nanjing Medical University, Nanjing, China.
Jianhua RaoHepatobiliary Center, Jiangsu Province Hospital, The First Affiliated Hospital, Nanjing Medical University, Nanjing, China.
Xinzheng DaiHepatobiliary Center, Jiangsu Province Hospital, The First Affiliated Hospital, Nanjing Medical University, Nanjing, China.
Qianwen ShaoDepartment of Oncology, Jiangsu Province Hospital, The First Affiliated Hospital, Nanjing Medical University, Nanjing, China.
Jie TangDepartment of Oncology, Liyang People's Hospital, Liyang, China.
Xiangcheng LiHepatobiliary Center, Jiangsu Province Hospital, The First Affiliated Hospital, Nanjing Medical University, Nanjing, China.
Yongqian ShuDepartment of Oncology, Jiangsu Province Hospital, The First Affiliated Hospital, Nanjing Medical University, Nanjing, China.
Jiangsu Province Hospital · CNGovernment of Jiangsu Province · CNJiangsu University · CNSoochow University · CNXuzhou Medical College · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: Immune checkpoint inhibitors plus antiangiogenic tyrosine kinase inhibitors may offer a first-line treatment for advanced hepatocellular carcinoma (HCC). In this phase 2 trial [registered with clinicaltrials.gov (NCT04052152)], we investigated the safety and efficacy of first-line anti-PD-1 antibody sintilimab plus antiangiogenic TKI anlotinib for advanced HCC. Methods and Materials: Pathologically-proven advanced HCC patients received sintilimab (200 mg) on day 1 and anlotinib (12 mg) once daily on days 1 to 14 every 3 weeks, with a safety run-in for the first six participants to assess dose-limiting toxicities (DLTs). The primary endpoints were safety and objective response rate (ORR) per RECIST v1.1. Results: Twenty advanced HCC patients were enrolled. No DLTs occurred in the safety run-in. All patients had treatment-related adverse events (TRAEs). Grade 3 TRAEs occurred in 8 (40.0%) patients, the most common being decreased platelet count (10.0%) and increased γ-glutamyl transferase (10.0%). No grade 4/5 TRAEs occurred. Five (25%) patients developed immune-related AEs. The ORR was 35.0% (95%CI 15.4%-59.2%) per RECIST v1.1 and 55.0% (95%CI 31.5%-76.9%) per modified RECIST. At data cutoff (March 31, 2021), the median progression-free survival was 12.2 months (95%CI, 3.8 to not reached). The median PFS was significantly longer in patients with lower LDH levels (not reached [NR], 95% CI, 8.7 to NR vs. higher LDH levels 5.2 months, 95% CI 3.4 to NR; Conclusion: Sintilimab plus anlotinib showed promising clinical activities with manageable toxicity as first-line treatment of advanced HCC.

Indexed as

advanced hepatocellular carcinomaanlotinibanti-PD1receptor tyrosine kinasesintilimab

Identifiers

PMID35712486
PMCPMC9197581
OpenAlexW4281658290

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.