NCT06601309RecruitingPhase 2
Biomarker Based Neoadjuvant Strategies for Locally Advanced Resectable ESCC
Biomarker Based Neoadjuvant Strategies for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma: an Exploratory Phase II Single-arm Clinical Study
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
This study aims to evaluate the impact of the neoadjuvant treatment strategy based on CPS score on the pathological complete response (pCR) rate in patients with resectable locally advanced esophageal cancer.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 10 Sept 2024
- Start date
- 11 Jul 2024
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- Fujian Medical University Union Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06601309
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 90
- From 11 Jul 2024 to the primary completion date, 31 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous Treatment: Previous treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies.
Other illness
- Other Malignancies: History of other malignancies within the past 5 years, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin carcinoma, or other localized non-invasive malignancy.
- Autoimmune Diseases: History of active autoimmune diseases requiring systemic treatment within the past 2 years.
- Infections: Active infection requiring systemic therapy.
- Uncontrolled Conditions: Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Allergies: Known allergy or hypersensitivity to study drugs or any excipient of these medications.
Lab values
- Pregnancy and Lactation: Pregnant or breastfeeding women. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization.
Other
- Distant Metastasis: Presence of distant metastasis.
Who the study is looking for
- Diagnosis: Histologically confirmed esophageal squamous cell carcinoma (ESCC).
- Stage: Resectable locally advanced ESCC (clinical stage II-III according to the AJCC/UICC 8th edition).
- Age: 18-75 years old.
- Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- PD-L1 Expression: Available PD-L1 expression level (CPS).
- Surgical Eligibility: Assessed as eligible for surgical resection by a thoracic surgeon.
- Laboratory Requirements:
- Adequate bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L, Platelets ≥ 100 x 10\^9/L, Hemoglobin ≥ 9 g/dL.
- Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN), AST and ALT ≤ 2.5 x ULN.
- Adequate renal function: Serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 60 mL/min.
- Informed Consent: Ability to understand and willingness to sign a written informed consent document.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fujian Medical University Union Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.