Neoadjuvant Therapy of PD-1 Blockade Combined With Chemotherapy for Locally Advanced Esophageal Carcinoma
Overview
- Phase
- Phase 1
- Intervention
- PD-1 blockade
- Conditions
- Esophageal Carcinoma
- Sponsor
- Beijing Friendship Hospital
- Enrollment
- 89
- Locations
- 1
- Primary Endpoint
- Disease-free survival (DFS)
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •age ≥ 18 years and ≤89 years;
- •pathological histological examination confirmed the diagnosis of esophageal squamous cell carcinoma and esophageal adenocarcinoma;
- •clinical stage II-IVA;
- •adequate organ function;
- •no previous chemotherapy or radiotherapy;
- •voluntarily signed informed consent.
Exclusion Criteria
- •the presence of concurrent malignancies that interfere with the prognosis of esophageal cancer;
- •patients with immunodeficiency or autoimmune diseases that seriously affect the body's immune system, such as those who test positive for HIV;
- •patients undergoing systemic corticosteroid or other immunosuppressive treatments;
- •patients with a history of allergy to the components of this test drug.
Arms & Interventions
Neoadjuvant PD-1 Blockade Plus Chemotherapy
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.
Intervention: PD-1 blockade
Neoadjuvant PD-1 Blockade Plus Chemotherapy
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.
Intervention: Albumin paclitaxel
Neoadjuvant PD-1 Blockade Plus Chemotherapy
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.
Intervention: Carboplatin/Nedaplatin
Outcomes
Primary Outcomes
Disease-free survival (DFS)
Time Frame: 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 Outcomes
- Pathologic complete remission (PCR)(4 weeks after surgery)
- Major Pathologic Response (MPR)(4 weeks after surgery)
- Overall survival (OS)(24 months)