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Early Response-guided Sequential Radiotherapy After Chemoimmunotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma

NCT07721103 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-07-22

No results posted yet for this study

Summary

Esophageal squamous cell carcinoma (ESCC) is a common and aggressive malignancy with poor prognosis, particularly in patients with locally advanced disease. Neoadjuvant chemoimmunotherapy has shown promising antitumor activity and may improve pathological response; however, a proportion of patients achieve only stable disease (SD) or progressive disease (PD) after initial treatment and may have limited benefit from proceeding directly to surgery.

This prospective, single-center, phase II clinical study aims to evaluate an early response-guided sequential selective radiotherapy strategy after neoadjuvant chemoimmunotherapy in patients with locally advanced, resectable ESCC. Patients will initially receive neoadjuvant chemotherapy combined with PD-1 inhibitor therapy. Based on radiological response assessment, patients with major response (complete response or partial response) will proceed directly to radical surgery, whereas patients with insufficient response (stable disease or progressive disease but still considered resectable) will receive sequential chemoradiotherapy followed by surgery.

The study aims to assess the safety and efficacy of this individualized treatment strategy, with primary evaluation focusing on pathological response, surgical outcomes, and treatment-related adverse events. Exploratory analyses will investigate potential biomarkers associated with treatment response and prognosis.

Conditions

  • Esophageal Squamous Cell Carcinoma (ESCC)

Interventions

DRUG

Neoadjuvant Chemoimmunotherapy (Tislelizumab Plus Paclitaxel and Cisplatin)

Participants will receive neoadjuvant chemoimmunotherapy before surgery. The regimen includes: Tislelizumab (PD-1 inhibitor): 200 mg administered intravenously once every 3 weeks for 2 cycles. Paclitaxel: 135 mg/m² administered intravenously on Day 1 of each 3-week cycle for 2 cycles. Cisplatin: 60 mg/m² administered intravenously on Day 1 of each 3-week cycle for 2 cycles. After completion of neoadjuvant chemoimmunotherapy, tumor response will be assessed. Treatment decisions will be guided by early response evaluation and multidisciplinary surgical assessment.

RADIATION

Sequential Chemoradiotherapy

Participants with inadequate response after neoadjuvant chemoimmunotherapy but remaining eligible for curative surgery will receive sequential chemoradiotherapy followed by surgery. Concurrent chemoradiotherapy consists of: Radiotherapy: 1.8 Gy per fraction, 5 fractions per week, for 5 weeks, with a total dose of 41.4 Gy in 23 fractions. Chemotherapy: weekly concurrent chemotherapy with paclitaxel and platinum-based chemotherapy during radiotherapy. The treatment aims to improve local tumor control before radical surgical resection.

Sponsors & Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-14
Primary Completion
2027-12-31
Completion
2031-12-31

Countries

  • China

Study Locations

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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 NCT07721103 on ClinicalTrials.gov