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

Hebei Medical University

Status: Active, not recruiting

Conditions: Esophageal Carcinoma

Study type: Observational

Funder types: Other

Identifiers

NCT06828718

2025KS008

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

1,000 participants in 4 patient groups

Neoadjuvant chemoradiotherapy

Description:

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

Neoadjuvant chemotherapy

Description:

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

Neoadjuvant chemotherapy combined with immunotherapy

Description:

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

Neoadjuvant chemoradiotherapy combined with immunotherapy

Description:

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