Actively Recruiting
Neoadjuvant Anti-PD-1 Plus Chemotherapy in Locally Advanced Resectable Esophageal Squamous Cell Carcinoma
Led by Shanghai Zhongshan Hospital · Updated on 2023-03-21
40
Participants Needed
1
Research Sites
417 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the outcomes and identify predictors of neoadjuvant anti-PD-1 plus chemotherapy in locally advanced resectable esophageal squamous cell carcinoma (ESCC). In this single-center cohort study, we are aiming to (1) evaluate the therapeutic efficacy and survival benefits on patients with locally advanced resectable ESCC (cT3-4aN0-1M0); (2) evaluate the value of genomic indicators including MMR alternation status in predicting therapeutic responses and prognosis; (3) evaluate the value of transcriptomic indicators including B cell lineage features in predicting therapeutic responses and prognosis; (4) evaluate the value of microbial and metabolite indicators in predicting therapeutic responses and prognosis. Whole exome sequencing, RNA sequencing, 16S rRNA sequencing and Liquid Chromatography with tandem mass spectrometry (LC-MS-MS) of samples of patients to neoadjuvant chemoimmunotherapy before and after treatment are performed to explore the mechanisms of drug resistance and identification of predictive and prognosis biomarkers.
CONDITIONS
Official Title
Neoadjuvant Anti-PD-1 Plus Chemotherapy in Locally Advanced Resectable Esophageal Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically-confirmed squamous cell carcinoma of the esophagus
- Tumors located in the thoracic cavity
- Pre-treatment stage of cT3-4aN0-1M0 (AJCC/UICC 7th Edition) with curative resectability verified for cT4a
- Age between 18 and 75 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate cardiac function with ECG and echocardiography if needed, left ventricular ejection fraction > 50%
- Adequate respiratory function with FEV1 ≥ 1.2L, FEV1% ≥ 50%, and DLCO ≥ 50%
- Adequate bone marrow function (White Blood Cells >4x10^9/L; Neutrophil >2.0x10^9/L; Hemoglobin > 90 g/L; platelets >100x10^9/L)
- Adequate liver function (Total bilirubin <1.5x Upper Level of Normal; AST and ALT <1.5x Upper Level of Normal)
- Adequate renal function (Glomerular filtration rate >60 ml/min; serum creatinine ≤120 µmol/L)
- Provided written informed consent and able to understand and comply with the study
You will not qualify if you...
- Non-squamous cell carcinoma histology
- Advanced inoperable or metastatic esophageal cancer
- Pre-treatment stage cT1-2N0-1M0 (AJCC/UICC 7th Edition)
- Pre-treatment stage cN2-3 or cT4b (non-curatively resectable)
- Previous or current other malignant disease interfering with treatment or response assessment
- Significant medical conditions unlikely to tolerate therapy, including cardiac disease, significant lung disease, or major organ dysfunction
- Pregnant or lactating women and fertile women not using contraception during the trial
- Allergy to any study drugs
- Participation in another clinical trial interfering with this treatment during or within 30 days prior to consent
- Expected lack of compliance with protocol
AI-Screening
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Trial Site Locations
Total: 1 location
1
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
J
Jie Gu, MD
CONTACT
D
Di Ge, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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