Neoadjuvant CRT Combined With Camrelizumab and Nimotuzumab for Initially Inoperable Patients With Esophageal Carcinoma

Conditions

• Toxicity, Drug

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• neoadjuvant chemoradiotherapy combined with Camrelizumab and Nimotuzumab followed by surgery — DRUG
  neoadjuvant chemoradiotherapy combined with Camrelizumab and Nimotuzumab followed by surgery

Study Details

Neoadjuvant chemoradiotherapy followed by surgery has been the standard modality for locally advance esophageal carcinoma. According to CROSS study, the pathological complete remission rate achieved by paclitaxel and carboplatin with 41.4 Gy/23f was 49% for esophageal squamous cell carcinoma. But the 10-year overall survival rate was only 38%. How to increase the overall survival of esophageal carcinoma is a pivotal task. Both of Camrelizumab and Nimotuzumab have been demonstrated to be efficacious in the neoadjuvant treatment for esophageal squamous cell carcinoma in some small sample-size trials. Therefore, this trial is designed to combine adjuvant chemoradiotherapy with Camrelizumab and Nimotuzumab for resectable \& potentially resectable locally advanced esophageal squamous cell carcinoma and explore the safety and primary efficacy of such combination.

Key Dates

Start date

Nov 1, 2021

Status verified

Dec 2024

Primary completion

Dec 31, 2023

Completion

Mar 31, 2024

Study Design

Enrollment

35 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Neoadjuvant treatment
  Neoadjuvant chemoradiotherapy combined with Camrelizumab and Nimotuzumab

Primary Outcome Measure

1-year progression free survival (PFS) rate [ Time Frame: 0 month post neoadjuvant treatment ]