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

Study Overview
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Brief Summary
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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.

Official Title
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Neoadjuvant Therapy of PD-1 Blockade Combined With Chemotherapy for Locally Advanced Esophageal Carcinoma

Conditions
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Esophageal Carcinoma, Neoadjuvant Immunotherapy

Intervention / Treatment
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* Drug: PD-1 blockade
* Drug: Albumin paclitaxel
* Drug: Carboplatin/Nedaplatin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neoadjuvant PD-1 Blockade Plus Chemotherapy<br>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. | Drug: PD-1 blockade<br>* PD-1 blockade (Sintilimab/Camrelizumab/Toripalimab/Tislelizumab), 200 mg, IV., every 3 weeks, 2-3 cycles.<br>Drug: Albumin paclitaxel<br>* Albumin paclitaxel, 300 mg/m2, IV., every 3 weeks, 2-3 cycles.<br>Drug: Carboplatin/Nedaplatin<br>* Carboplatin/Nedaplatin, area under the curve = 5, IV., every 3 weeks, 2-3 cycles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival (DFS) | Disease-free survival was defined as the time from randomization until the first documented disease recurrence or death due to any cause. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathologic complete remission (PCR) | Primary tumor or lymph node surgery specimen pathological examination without residual tumor cell. | 4 weeks after surgery | 
| Major Pathologic Response (MPR) | MPR was defined as the presence of viable tumor cells≤10% in the resected tumor specimen. | 4 weeks after surgery | 
| Overall survival (OS) | Overall survival was defined as the time from randomization grouping to the time of death due to any cause. | 24 months |