MedTrace Logo

Adaptive Neoadjuvant Therapy for Esophageal Cancer

NCT06990178 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2025-05-25

No results posted yet for this study

Summary

This study is a multicenter, single-arm phase II trial, aiming to evaluate the efficacy and safety of neoadjuvant chemotherapy and immunotherapy combined with concurrent low-dose radiotherapy ± chemoradiotherapy as an adaptive neoadjuvant treatment for previously untreated resectable esophageal squamous cell carcinoma. Compared with neoadjuvant concurrent chemoradiotherapy, the pathological complete response (pCR) rate of neoadjuvant chemoradiotherapy is lower, and non-pCR has a relatively poorer prognosis than pCR. Therefore, how to further increase the pCR rate of neoadjuvant chemoradiotherapy under the premise of minimum toxicity is an important link to improve the efficacy of this treatment strategy. Low-dose radiotherapy provides an option for this strategy. Compared with traditional high-dose radiotherapy, low-dose radiotherapy is very safe, and the extremely low radiotherapy dose causes almost negligible damage to normal tissues. However, it can effectively reshape the immune microenvironment, converting cold tumors into hot tumors. On this basis, combined with immune checkpoint inhibitors, it can achieve effective immune responses in advanced tumors, bringing new hope for the treatment of advanced tumor patients. Low-dose radiotherapy can regulate the tumor immune microenvironment through multiple mechanisms and enhance the body's anti-tumor immune response, thus potentially further improving the efficacy of neoadjuvant chemoradiotherapy for esophageal squamous cell carcinoma.

Conditions

  • Esophageal Carcinoma
  • Neoadjuvant Therapy

Interventions

RADIATION

Neoadjuvant concurrent chemoradiotherapy

Non-cCR group will continue with neoadjuvant concurrent chemoradiotherapy (2Gy\*20f) followed by radical surgery

Sponsors & Collaborators

  • Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center

    lead OTHER

Principal Investigators

  • Tao Zhen Yu, MD · National Cancer Center/ Cancer Hospital &Shenzhen Hospital Chinese Academy of Medical Sciences and Peking Union Medical College

  • Wei Jiang, MD · National Cancer Center/ Cancer Hospital &Shenzhen Hospital Chinese Academy of Medical Sciences and Peking Union Medical College

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2028-03-01
Primary Completion
2028-03-01
Completion
2028-03-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06990178 on ClinicalTrials.gov