Evidence map›Paper›PMID 35380726›Full record

Trial reportThe oncologist2022

Rh-Endostatin Plus Irinotecan/Cisplatin as Second-Line Therapy for Advanced Esophageal Squamous Cell Carcinoma: An Open-Label, Phase II Study.

Zhihuang Hu, Si Sun, Xinmin Zhao, Hui Yu, Xianghua Wu, Jialei Wang, Jianhua Chang, Huijie Wang

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

Trial report in The oncologist, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03797625 (Endostar Combined With IP Second-line Treatment of Advanced Esophageal Squamous Cell Carcinomas of the Prospective, Single Arm Phase II Clinical Study), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
3.6field-weighted citation impact, top 6% 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.

NCT03797625 phase2completednot on this map

Endostar Combined With IP Second-line Treatment of Advanced Esophageal Squamous Cell Carcinomas of the Prospective, Single Arm Phase II Clinical Study

TypeinterventionalSponsorFudan UniversityRan2017 to 2021Enrolled52ConditionsEsophageal Squamous Cell CarcinomaArmsIrinotecan, DDP, Endostar
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 35 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Review
  5. 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

8 authors at 4 institutions in 1 country.

Zhihuang HuDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China.
Si SunDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China.
Xinmin ZhaoDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China.
Hui YuDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China.
Xianghua WuDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China.
Jialei WangDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China.
Jianhua ChangDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China.
Huijie WangDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China.
Fudan University Shanghai Cancer Center · CNFudan University · CNShanghai Medical College of Fudan University · CNChinese Academy of Medical Sciences & Peking Union Medical College · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis open-label, phase II study aimed to investigate the efficacy and safety of recombinant human endostatin (Rh-endostatin) plus irinotecan/cisplatin as second-line treatment in patients with advanced esophageal squamous cell carcinoma (ESCC).

methodsEligible patients received 15mg/m2 Rh-endostatin as a continuous intravenous pump infusion (7 continuous days), 60mg/m2 irinotecan (days 1 and 8), and 60mg/m2 cisplatin (day 1) every 3 weeks. The primary endpoint was progression-free survival (PFS).

resultsA total of 50 patients were assessable for efficacy and safety analysis. The median follow-up was 10.97 months (95%CI: 7.03-19.42) as the data cutoff. Median PFS was 4.01 months (95% CI: 3.19-5.49), and median overall survival (OS) was 12.32 months (95% CI: 8.21-17.45); 13 (26%; 95% CI: 15.87-39.55) of 50 patients had an objective response, and 31 (62%; 95% CI: 48.15-74.14) had disease control. Grade 3 or greater treatment-related adverse events (AEs) occurred in 12 (24.0%) patients, and no deaths were reported. The common grade 3 or greater AEs were leucopenia (18.0%) and neutropenia (16.0%). Five (10%) patients discontinued treatment because of AEs.

conclusionRh-endostatin plus irinotecan/cisplatin showed promising anti-tumor activity in advanced ESCC patients with a good safety profile in the second-line setting, which warrants further study in this population. (ClinicalTrials.gov identifier: NCT03797625).

Indexed as

Esophageal NeoplasmsEsophageal Squamous Cell CarcinomaAntineoplastic Combined Chemotherapy ProtocolsCisplatinEndostatinsHumansIrinotecanCisplatinEndostatinsIrinotecancisplatinesophageal squamous cell carcinomairinotecanphase II studyrecombinant human endostatin (Rh-endostatin)

Identifiers

PMID35380726
PMCPMC8982371
OpenAlexW4205509900

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.