Actively Recruiting
Neoadjuvant Anti-PD-1 Plus Chemotherapy in Locally Advanced Resectable Esophageal Squamous Cell Carcinoma in a Single-Center Cohort Study
Led by Shanghai Zhongshan Hospital · Updated on 2023-03-21
40
Participants Needed
1
Research Sites
261 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the outcomes and predictors of neoadjuvant anti-PD-1 plus chemotherapy in patients with locally advanced resectable esophageal squamous cell carcinoma (ESCC). This single-center cohort study aims to assess the treatment's therapeutic efficacy and survival benefits, as well as evaluate genomic, transcriptomic, microbial, and metabolite indicators that might predict therapeutic responses and prognosis. Advanced techniques like whole exome sequencing, RNA sequencing, 16S rRNA sequencing, and liquid chromatography with tandem mass spectrometry are used to explore drug resistance mechanisms and identify biomarkers. Patients receive preoperative treatment consisting of two cycles of chemotherapy with Nab-paclitaxel and cisplatin every three weeks, alongside PD-1 antibody infusions every three weeks. After completing 3-4 cycles of this neoadjuvant chemoimmunotherapy, patients undergo esophagectomy surgery. It is recommended to continue four cycles of the same chemoimmunotherapy within six weeks after surgery. During the study, participants provide biological samples before and after treatment for detailed analysis. Researchers monitor major pathological regression (MPR) rates up to six months from enrollment and assess additional outcomes like pathological response, objective response rate, overall survival, and progression-free survival for up to 36 months after the last participant joins. The study also tracks correlations between genomic, immune, microbial, and metabolite features with treatment responses, aiming to guide future clinical decisions.
CONDITIONS
Brief 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 cT3-4aN0-1M0 (verified curative resectability for cT4a)
- Age between 18 and 75 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate cardiac function (ECG and echocardiography with left ventricular ejection fraction > 50% if indicated)
- Adequate respiratory function (FEV1 ≥ 1.2L, FEV1% ≥ 50%, DLCO ≥ 50%)
- Adequate bone marrow function (WBC > 4x10^9/L; Neutrophil > 2.0x10^9/L; Hemoglobin > 90 g/L; Platelets > 100x10^9/L)
- Adequate liver function (Total bilirubin <1.5x ULN; AST and ALT <1.5x ULN)
- Adequate renal function (CCr > 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
- Pre-treatment stage cN2-3 or cT4b (non-curatively resectable)
- Another previous or current malignant disease interfering with treatment or response assessment
- Significant medical conditions likely to prevent therapy tolerance (e.g. recent heart attack, serious lung disease, severe bone marrow, liver, or kidney disorders)
- Pregnant or lactating women, or fertile women not using contraception
- Allergy to any study drugs
- Participation in another interventional clinical trial affecting this treatment within 30 days prior to consent
- Expected lack of compliance with the study protocol
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 to 4 cycles every 3 weeks
Participants receive neoadjuvant anti-PD-1 plus chemotherapy before surgery.
Every 3 weeks for 3 to 4 visits (in-person)
Duration - Surgery day plus immediate recovery period
Participants undergo esophagectomy surgery followed by immediate post-operative care.
1 surgical procedure and subsequent hospital stay
Duration - Up to 6 weeks with 4 cycles every 3 weeks
Participants receive 4 cycles of postoperative anti-PD-1 plus chemotherapy as neoadjuvant therapy continuation.
Every 3 weeks for up to 4 visits (in-person)
Duration - Up to 36 months after last treatment
Participants are monitored for therapeutic response, survival, and biological sample collection for biomarker analysis.
Periodic visits during follow-up as scheduled by study team
Trial Site Locations
Total: 1 location
1
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
J
Jie Gu, MD
D
Di Ge, MD
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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