Clinical trial NCT06828718: The Neoadjuvant Treatment Modalities in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma (NEO-EC）
Official title: Comparison of the Prognosis and Safety of Different Neoadjuvant Treatment Modalities in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma: A National Multicenter Real-World Study(NEO-EC）
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Esophageal Carcinoma
Keywords: Esophageal Carcinoma
Neoadjuvant therapy
Prognosis
Lead sponsor: Hebei Medical University Fourth Hospital
Sponsor class: OTHER
Collaborators: name: Tianjin Medical University Cancer Institute and Hospital
name: Fujian Cancer Hospital
name: Shandong Cancer Hospital and Institute
name: Shanxi Province Cancer Hospital
name: Jiangsu Cancer Institute & Hospital
name: Sichuan Cancer Hospital and Research Institute
First posted: 2025-02-14
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: we compared the prognosis and safety of patients with locally advanced esophageal squamous cell carcinoma who received different neoadjuvant therapy before surgery, including neoadjuvant chemoradiotherapy, neoadjuvant chemotherapy, neoadjuvant chemotherapy combined with immunotherapy, and neoadjuvant chemoradiotherapy combined with immunotherapy in several cancer centers in China.

Brief summary: The prognosis and safety of patients with locally advanced esophageal squamous cell carcinoma were compared with different neoadjuvant therapy modes in multi-cancer centers in China

Detailed description: Neoadjuvant chemoradiotherapy or neoadjuvant chemotherapy combined with surgery are the main treatment methods for patients with locally advanced esophageal squamous cell carcinoma, but some patients still have local recurrence or distant metastasis after surgery. In the era of immunotherapy, immune checkpoint inhibitor monotherapy or combined chemotherapy has become the first-line and second-line standard treatment for recurrent or metastatic esophageal cancer and has been recommended by NCCN guidelines. However, relevant studies on immunotherapy's participation in neoadjuvant therapy have shown good results, but it is still in its initial stage, and its efficacy needs further research and discussion.Thus, we compared the prognosis and safety of patients with locally advanced esophageal squamous cell carcinoma who received different neoadjuvant therapy before surgery, including neoadjuvant chemoradiotherapy, neoadjuvant chemotherapy, neoadjuvant chemotherapy combined with immunotherapy, and neoadjuvant chemoradiotherapy combined with immunotherapy in several cancer centers in China.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years, male or female;
2. KPS score (KPS) ≥70;
3. Esophageal squamous cell carcinoma confirmed by histopathology;
4. Clinical stage cT1b-4aN+M0,T3-4aN0M0;
5. Surgical resection was performed after 2\~4 cycles of neoadjuvant therapy.
6. Expected survival \> 6 months.

Exclusion Criteria:

1. Have a history of other malignancies (except for cancer in situ that has been cured and other malignancies that have been cured for more than 5 years);
2. There are contraindications of immunotherapy or chemoradiotherapy;
3. Inability to tolerate or refuse surgery;
4. Distant metastasis has occurred;

Primary outcomes:
measure: Comparison of pathological complete response rate (pCR) after surgical resection in patients with locally advanced esophageal squamous cell carcinoma receiving different neoadjuvant therapy
timeFrame: 2015.1.1-2023.12.31
measure: Comparison of major pathological response (MPR) after surgical resection in patients with locally advanced esophageal squamous cell carcinoma receiving different neoadjuvant therapy
timeFrame: 2015.1.1-2023.12.31
Secondary outcomes:
measure: Comparison of the overall survival (OS) after surgical resection in patients with locally advanced esophageal squamous cell carcinoma receiving different neoadjuvant therapy
timeFrame: 2015.1.1-2025.12.31
measure: Comparison of the disease-free survival (DFS) after surgical resection in patients with locally advanced esophageal squamous cell carcinoma receiving different neoadjuvant therapy
timeFrame: 2015.1.1-2025.12.31
Other outcomes:
measure: Comparison of incidence of treatment-related adverse evants after surgical resection in patients with locally advanced esophageal squamous cell carcinoma receiving different neoadjuvant therapy
timeFrame: 2015.1.1-2025.12.31
Locations:
city: Shijiazhuang
country: China
state: Hebei
Study officials:
References: