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NCT05174325

Effectiveness of Neoadjuvant Chemotherapy Combined With PD-1 Monoclonal Antibody in the Treatment of Operable Esophageal Squamous Cell Carcinoma

Status unknown Phase 2 Last updated 30 December 2021
What this trial tests

Phase 2 trial testing Sintilimab + chemotherapy in Esophageal Squamous Cell Carcinoma in 30 participants. Status unknown.

Timeline
1 December 2020
Primary endpoint
1 June 2022
1 July 2022

Quick facts

Lead sponsorThe First Affiliated Hospital of Soochow University
PhasePhase 2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment30
Start date1 December 2020
Primary completion1 June 2022
Estimated completion1 July 2022
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

The First Affiliated Hospital of Soochow University

Who can join

Adults 18 to 75, any sex, with Esophageal Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study aims to evaluate the efficacy of sintilimab combined with concurrent chemotherapy as a neoadjuvant treatment for patients with operable esophageal squamous cell carcinoma. It will also evaluate the changes in the immune microenvironment of tumor specimens before and after the medication, and predict the operable period (stage I\~III) Patients with thoracic esophageal squamous cell carcinoma were treated with neoadjuvant chemotherapy combined with PD-1 monoclonal antibody, and the effect of neoadjuvant chemotherapy combined with PD-1 monoclonal antibody was evaluated by detecting the changes of microbial diversity and metabolites in stool samples before and after treatment.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Neoadjuvant immunotherapy for resectable esophageal cancer: A review.
    Li Q, Liu T, Ding Z. · · 2022 · cited 43× · PMID 36569908 · DOI 10.3389/fimmu.2022.1051841
  2. Immune evasion in esophageal squamous cell cancer: From the perspective of tumor microenvironment.
    Li R, Huang B, Tian H, Sun Z. · · 2022 · cited 33× · PMID 36698392 · DOI 10.3389/fonc.2022.1096717
  3. Current state of the art: immunotherapy in esophageal cancer and gastroesophageal junction cancer.
    Li N, Sohal D. · · 2023 · cited 22× · PMID 37995002 · DOI 10.1007/s00262-023-03566-5
  4. Immunotherapy in the neoadjuvant treatment of gastrointestinal tumors: is the time ripe?
    Gervaso L, Ciardiello D, Oliveira RA, Borghesani M, et al · · 2024 · cited 12× · PMID 38782539 · DOI 10.1136/jitc-2023-008027

Verify or expand the search:

Other recruiting trials for Esophageal Squamous Cell Carcinoma

Currently open trials in the same condition.

Other The First Affiliated Hospital of Soochow University trials

Trials by the same sponsor.

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Data sources for this page

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