Esophageal Carcinoma, Neoadjuvant Immunotherapy
Conditions
Brief 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.
Interventions
DRUGPD-1 blockade
PD-1 blockade (Sintilimab/Camrelizumab/Toripalimab/Tislelizumab), 200 mg, IV., every 3 weeks, 2-3 cycles.
DRUGAlbumin paclitaxel
Albumin paclitaxel, 300 mg/m2, IV., every 3 weeks, 2-3 cycles.
DRUGCarboplatin/Nedaplatin
Carboplatin/Nedaplatin, area under the curve = 5, IV., every 3 weeks, 2-3 cycles.
Sponsors
Beijing Friendship Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival (DFS) | 24 months | Disease-free survival was defined as the time from randomization until the first documented disease recurrence or death due to any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pathologic complete remission (PCR) | 4 weeks after surgery | Primary tumor or lymph node surgery specimen pathological examination without residual tumor cell. |
| Major Pathologic Response (MPR) | 4 weeks after surgery | MPR was defined as the presence of viable tumor cells≤10% in the resected tumor specimen. |
| Overall survival (OS) | 24 months | Overall survival was defined as the time from randomization grouping to the time of death due to any cause. |
Countries
China
Contacts
Primary ContactQin Li, MD
Outcome results
None listed