NCT05028231

Neoadjuvant Immunotherapy (PD-1 / PD-L1) Combined With Chemotherapy for Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma: a Single Center, Prospective, Open, One Arm Exploratory Clinical Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 46 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

To purpose of this study is to access the safety and efficacy of neoadjuvant Immunotherapy (PD-1 / PD-L1) combined with chemotherapy for locally advanced thoracic esophageal squamous cellcarcinoma.

Detailed description

Each patient will complete 2 cycles of neoadjuvant therapy and decide whether to operate after evaluating the curative effect if there is no active withdrawal of the subject from the trial or the researcher believes that the subject is not suitable for further trials. The patients after operation and without operation enter the survival follow-up period. If the imaging evaluation is PD after neoadjuvant therapy, the follow-up treatment shall be carried out according to the following principles: the imaging evaluation belongs to the continuous operation that can be operated; If the imaging evaluation was inoperable, radical concurrent radiotherapy and chemotherapy were performed. Postoperative adjuvant therapy shall be performed according to NCCN guidelines. If it is necessary to improve the local control rate, postoperative adjuvant radiotherapy is feasible. At the same time, imaging evaluation was performed until tumor recurrence and metastasis. After tumor recurrence and metastasis, all patients should also enter survival follow-up; In case of drug withdrawal (such as intolerable toxicity) other than recurrence and metastasis during treatment, the treatment is completed, the post-treatment visit is entered, and the survival follow-up is entered after recurrence.

Conditions

• Esophageal Squamous Cell Carcinoma
• Neoadjuvant Therapies

Interventions

Type	Name	Description
PROCEDURE	Neoadjuvant Immunotherapy (PD-1 / PD-L1) Combined With Chemotherapy	Each patient will complete 2 cycles of neoadjuvant therapy. After evaluating the curative effect, decide whether to operate or not. Patients with and without surgery enter the survival follow-up period.

Timeline

• Start date: 2021-06-05
• Primary completion: 2022-12-31
• Completion: 2024-12-31
• First posted: 2021-08-31
• Last updated: 2021-08-31

Locations

1 site across 1 country: China