Early Response-guided Sequential Radiotherapy After Chemoimmunotherapy for Locally Advanced Esoph… (NCT07721103) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Early Response-guided Sequential Radiotherapy After Chemoimmunotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma
China110 participantsStarted 2026-07-14
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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Participants must meet all of the following criteria:
Provide written informed consent before enrollment.
Age \>18 years, male or female.
Histologically confirmed thoracic esophageal squamous cell carcinoma (ESCC).
Locally advanced, resectable disease according to AJCC/UICC 8th edition TNM staging system, defined as:
cT3-4aN0-2M0 or cT1-2N1-2M0;
No evidence of distant metastasis;
Considered initially resectable by a multidisciplinary surgical team.
Patients who have received neoadjuvant chemoimmunotherapy and have measurable disease response assessment according to RECIST v1.1, including complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD).
At least one measurable lesion according to RECIST version 1.1.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Expected survival time \>6 months.
Adequate organ function meeting the following criteria:
Bone marrow function:
Absolute neutrophil count ≥1,500/mm³;
Platelet count ≥100,000/mm³;
Hemoglobin ≥9 g/dL.
Renal function:
Serum creatinine ≤1.5 mg/dL and/or creatinine clearance ≥60 mL/min.
Hepatic function:
Total bilirubin ≤1.5 × upper limit of normal (ULN);
AST and ALT ≤1.5 × ULN.
Participants of childbearing potential must agree to use medically approved contraception during study treatment and for 3 months after completion of treatment. Female participants of childbearing potential must have a negative serum or urine pregnan…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and Tolerability Equivalent Major Pathological Response Rate (ITT-MPR)
Timeframe: Up to approximately 1.5 years
Trial details
NCT IDNCT07721103
SponsorTianjin Medical University Cancer Institute and Hospital