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Trial Title:
Neoadjuvant Therapy of PD-1 Blockade Combined With Chemotherapy for Esophageal Carcinoma
NCT ID:
NCT05777707
Condition:
Esophageal Carcinoma
Neoadjuvant Immunotherapy
Conditions: Official terms:
Carcinoma
Esophageal Neoplasms
Paclitaxel
Carboplatin
Nedaplatin
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
PD-1 blockade
Description:
PD-1 blockade (Sintilimab/Camrelizumab/Toripalimab/Tislelizumab), 200 mg, IV., every 3
weeks, 2-3 cycles.
Arm group label:
Neoadjuvant PD-1 Blockade Plus Chemotherapy
Intervention type:
Drug
Intervention name:
Albumin paclitaxel
Description:
Albumin paclitaxel, 300 mg/m2, IV., every 3 weeks, 2-3 cycles.
Arm group label:
Neoadjuvant PD-1 Blockade Plus Chemotherapy
Intervention type:
Drug
Intervention name:
Carboplatin/Nedaplatin
Description:
Carboplatin/Nedaplatin, area under the curve = 5, IV., every 3 weeks, 2-3 cycles.
Arm group label:
Neoadjuvant PD-1 Blockade Plus Chemotherapy
Summary:
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
89 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Qin li
Address:
City:
Beijing
Zip:
100029
Country:
China
Status:
Recruiting
Contact:
Last name:
Qin Li, MD
Phone:
13701288153
Email:
qinli128003@ccmu.edu.cn
Start date:
October 29, 2020
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Beijing Friendship Hospital
Agency class:
Other
Source:
Beijing Friendship Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05777707
