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Neoadjuvant Therapy of PD-1 Blockade Combined With Chemotherapy for Esophageal Carcinoma

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Capital Medical University

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Esophageal Carcinoma
Neoadjuvant Immunotherapy

Treatments

Drug: PD-1 blockade
Drug: Carboplatin/Nedaplatin
Drug: Albumin paclitaxel

Study type

Interventional

Funder types

Other

Identifiers

NCT05777707
BeijingHF

Details and patient eligibility

About

This prospective study aims to clarify the clinical efficacy and survival prognosis of neoadjuvant immune checkpoint inhibitor (ICI) combined with chemotherapy for esophageal cancer. It also explores predictive biomarkers and potential therapeutic targets for locally advanced esophageal cancer based on plasma metabolomics and peripheral blood immune cell clustering analysis. Each patient received 2-3 cycles of neoadjuvant immunotherapy with programmed cell death 1 (PD-1) blockade in combination with albumin paclitaxel and platinum. Exploratory analysis of plasma metabolomics combined with peripheral blood subsets of immune cells can reveal biomarkers that predict the efficacy and prognosis of patients undergoing neoadjuvant immunotherapy for locally advanced esophageal cancer, which also provide new ideas for the selection of immune adjuvants and therapeutic targets in ICIs combination therapy strategies.

Enrollment

89 estimated patients

Sex

All

Ages

18 to 89 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. age ≥ 18 years and ≤89 years;
  2. pathological histological examination confirmed the diagnosis of esophageal squamous cell carcinoma and esophageal adenocarcinoma;
  3. clinical stage II-IVA;
  4. adequate organ function;
  5. no previous chemotherapy or radiotherapy;
  6. voluntarily signed informed consent.

Exclusion criteria

  1. the presence of concurrent malignancies that interfere with the prognosis of esophageal cancer;
  2. patients with immunodeficiency or autoimmune diseases that seriously affect the body's immune system, such as those who test positive for HIV;
  3. patients undergoing systemic corticosteroid or other immunosuppressive treatments;
  4. patients with a history of allergy to the components of this test drug.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

89 participants in 1 patient group

Neoadjuvant PD-1 Blockade Plus Chemotherapy
Experimental group
Description:
PD-1 blockade, 200 mg, IV., every 3 weeks, 2-3 cycles; Albumin paclitaxel, 300 mg/m2, IV., every 3 weeks, 2-3 cycles; Carboplatin/Nedaplatin, area under the curve = 5, IV., every 3 weeks, 2-3 cycles.
Treatment:
Drug: PD-1 blockade
Drug: Albumin paclitaxel
Drug: Carboplatin/Nedaplatin

Trial contacts and locations

1

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Central trial contact

Qin Li, MD

Data sourced from clinicaltrials.gov

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