Adaptive Neoadjuvant Therapy for Esophageal Cancer

Sponsor
Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
Study ID
NCT06990178
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 1, 2028
Status verified
May 2025
Primary completion
Mar 1, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
43 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Neoadjuvant chemotherapy + immunotherapy+ low-dose radiotherapy (4Gy/2F)
    Eligible ESCC patients will receive standard neoadjuvant chemotherapy + immunotherapy, low-dose radiotherapy (4Gy/2F), and chemotherapy + immunotherapy (regimen: albumin-bound paclitaxel + carboplatin + tislelizumab q3w). After two cycles, imaging and endoscopic ultrasound, as well as pathological evaluations will be conducted. Patients will be stratified based on whether they achieve complete clinical response (cCR). The cCR group will undergo radical surgery, while the non-cCR group will continue with neoadjuvant concurrent chemoradiotherapy (2Gy\*20f) followed by radical surgery. Postoperative adjuvant therapy will be administered as per routine

Primary Outcome Measure

pCR [ Time Frame: Immediately after the surgery ]

Related Studies