Evidence map›Paper›PMID 40228531›Full record

Trial reportThoracic cancer2025

Polymeric Micellar Paclitaxel Plus Cisplatin Combined With Tislelizumab as the First-Line Treatment of Advanced Unresectable Esophageal Squamous Cell Carcinoma: A Phase II Study.

Xiaoyou Li, Jiamin Shi, Jinghua Zhu, Jingni Zhu, Fei Yan, Delin Liu, Guochun Cao

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in Thoracic cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. 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

7 authors.

Xiaoyou LiDepartment of Medical Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.ORCID https://orcid.org/0000-0002-0307-3534
Jiamin ShiDepartment of Medical Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.
Jinghua ZhuDepartment of Medical Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.
Jingni ZhuDepartment of Medical Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.
Fei YanDepartment of Medical Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.
Delin LiuDepartment of Medical Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.
Guochun CaoDepartment of Medical Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.

Funding

Yishan Research Project of Jiangsu Cancer Hospital YSPY202409
6 · The paper itself

Abstract

backgroundThe current standard treatment for advanced and metastatic esophageal squamous cell carcinoma (ESCC) involves a combination of immunotherapy and chemotherapy, but paclitaxel's hormone preconditioning can reduce immune response and effectiveness. Polymeric micellar paclitaxel (Pm-Pac), a nanoformulation, bypasses this issue, enhancing tumor permeability and retention. While Pm-Pac has shown promise in non-small cell lung cancer, its efficacy in ESCC is yet to be established.

methodsThis is a prospective phase II trial involving untreated stage IV ESCC receiving two cycles of Pm-Pac, cisplatin, and tislelizumab. If no disease progression was observed, they received two additional cycles followed by a year of tislelizumab maintenance. Each 3-week cycle consisted of Pm-Pac (230 mg/m

resultsBetween September 1, 2022, and June 30, 2024, 23 patients were included in the study. The median follow-up period was 14.8 months. The ORR stood at 69.6% (95% CI: 0.45-0.84) with a DCR of 100% (95% CI: 0.86-1.00). Out of the patients, 2 experienced complete responses, 14 had partial responses, and 7 maintained stable diseases. The mPFS was 10.8 months (95% CI: 0.26-0.632). The 1-year OS rate was 69.6% (95% CI: 49.1-84.4). Notably, no grade 3 or higher treatment-related adverse events or treatment-linked fatalities were reported.

conclusionsThe combination of Pm-Pac, cisplatin, and tislelizumab as an initial therapy for advanced ESCC is safe and effective and should be tested on a larger scale in the future.

trial registrationChinese Clinical Trial Registry: ChiCTR2400088576.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCisplatinEsophageal NeoplasmsEsophageal Squamous Cell CarcinomaPaclitaxelAdultAgedFemaleHumansMaleMicellesMiddle AgedProspective StudiesAntibodies, Monoclonal, HumanizedCisplatinMicellesPaclitaxeltislelizumabchemotherapyesophageal squamous cell carcinomaimmunologypolymeric micellar paclitaxeltislelizumab

Identifiers

PMID40228531
PMCPMC11996230

What OpenQuestion holds

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Registered trials

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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.