Clinical trial NCT06472635: a Neo-adjuvant Chemotherapy Immunotherapy in Resectable ESCC Study
Official title: A Retrospective, Multicenter, Single-arm Real-world Study on a New Adjuvant Chemotherapy Combined With Immune Inhibitors for Resectable Esophageal Squamous Cell Carcinoma (ESCC)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: The Neoadjuvant Treatment for Resectable Esophageal Squamous Cell Carcinoma
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Esophageal Squamous Cell Carcinoma (ESCC), with a follow-up cutoff date of March 2024, is expected to take 6 months for data cleaning and analysis, and the data collection and analysis are anticipated to be completed in September 2024.

Brief summary: Research Purpose 1: To evaluate the therapeutic efficacy and safety of neoadjuvant immunotherapy combined with chemotherapy in the treatment of resectable locally advanced esophageal squamous cell carcinoma (ESCC) in the real-world setting.

Research Purpose 2: To analyze the influencing factors of the therapeutic effect of neoadjuvant immunotherapy combined with chemotherapy in the treatment of resectable locally advanced esophageal squamous cell carcinoma (ESCC) in the real-world setting.

Research Purpose 3: To understand the treatment patterns of neoadjuvant immunotherapy combined with chemotherapy in the treatment of resectable locally advanced ESCC in the

Detailed description: Research Purpose 1: To evaluate the therapeutic efficacy and safety of neoadjuvant immunotherapy combined with chemotherapy in the treatment of resectable locally advanced esophageal squamous cell carcinoma (ESCC) in the real-world setting.

Research Purpose 2: To analyze the influencing factors of the therapeutic effect of neoadjuvant immunotherapy combined with chemotherapy in the treatment of resectable locally advanced esophageal squamous cell carcinoma (ESCC) in the real-world setting.

Research Purpose 3: To understand the treatment patterns of neoadjuvant immunotherapy combined with chemotherapy in the treatment of resectable locally advanced ESCC in the

Eligibility criteria: Inclusion Criteria:

Age ≥ 18 years (including 18 years old); ECOG 0 or 1; Patients with esophageal squamous cell carcinoma judged to be resectable (including initially non-resectable) by the researcher Received esophageal radical surgery and neoadjuvant immune chemotherapy before surgery Clinical staging belongs to: T1b-4NanyM0;

Exclusion Criteria:

Patients without complete medical information; Received other anti-tumor treatment before surgery; Received radiotherapy treatment; Judged by the researcher, have other conditions unsuitable for participating in this clinical study.

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Primary outcomes:
measure: Pathological Complete Response (pCR)
timeFrame: 12 months
Secondary outcomes:
measure: Resection Rate
timeFrame: 12 months
Other outcomes:
measure: ORR
timeFrame: 12 months
Locations:
city: Hangzhou
country: China
facility: The first affiliated hospital of Zhejiang University
state: Zhejiang
Study officials:
References: