The Neoadjuvant Treatment Modalities in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma (NEO-EC)

NCT ID: NCT06828718

Last Updated: 2025-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-01

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Esophageal Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Neoadjuvant chemoradiotherapy

Patients with locally advanced esophageal squamous cell carcinoma received neoadjuvant chemoradiotherapy and then underwent surgical resection

No interventions assigned to this group

Neoadjuvant chemotherapy

Patients with locally advanced esophageal squamous cell carcinoma received neoadjuvant chemotherapy followed by surgical resection

No interventions assigned to this group

Neoadjuvant chemotherapy combined with immunotherapy

Patients with locally advanced esophageal squamous cell carcinoma underwent surgical resection after neoadjuvant chemotherapy combined with immunotherapy

No interventions assigned to this group

Neoadjuvant chemoradiotherapy combined with immunotherapy

Patients with locally advanced esophageal squamous cell carcinoma underwent surgical resection after neoadjuvant chemoradiotherapy combined with immunotherapy

No interventions assigned to this group

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role collaborator

Fujian Cancer Hospital

OTHER_GOV

Sponsor Role collaborator

Shandong Cancer Hospital and Institute

OTHER

Sponsor Role collaborator

Shanxi Province Cancer Hospital

OTHER

Sponsor Role collaborator

Jiangsu Cancer Institute & Hospital

OTHER

Sponsor Role collaborator

Sichuan Cancer Hospital and Research Institute

OTHER

Sponsor Role collaborator

Hebei Medical University Fourth Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shijiazhuang, Hebei, China

Site Status

Countries

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China

Other Identifiers

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2025KS008

Identifier Type: -

Identifier Source: org_study_id

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