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New treatment option for Locally Advanced Esophageal Squamous Cell Carcinoma
Official title Optimizing Neoadjuvant Treatment Regimens for Locally Advanced Esophageal Squamous Cell Carcinoma
ClinicalTrials.gov ID: NCT06907602
What this study is testing
What is Chemotherapy?
Chemotherapy is an investigational medicine, being studied as a potential treatment for locally advanced esophageal squamous cell carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Our previous study, a single-center, prospective, single-arm Phase II study (Keypoint001) has demonstrated the efficacy and safety of neoadjuvant chemotherapy combined with immunotherapy in locally advanced (cT3-4N+M0) esophageal squamous cell carcinoma. The results show that the pathological complete response rate (pCR) reaches 35%, and the major pathological response rate is over 70%, which is much higher than that of patients receiving chemotherapy alone.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- male or female
- Age ≥ 18 years old
- Pathological confirmation of esophageal squamous cell carcinoma
- Endoscopic ultrasound, enhanced CT scan of the neck, chest, and abdomen, and esophageal magnetic resonance imaging evaluate as T3 or resectable T4...
- No clear distant metastasis (M0) and only cervical or supraclavicular lymph node metastasis (M1a)
You likely can't join if
- T staging evaluation is T1/T2
- PET/CT and other evaluations show distant metastasis (M1)
- Planned pregnancy or patients during pregnancy or lactation
- History of previous chemotherapy, radiation therapy, or immunotherapy
- Previous severe coronary heart disease and heart failure (NYHA grade III/IV)
- Previous pulmonary interstitial fibrosis or severe pulmonary dysfunction that cannot tolerate surgery
See the full eligibility criteria
- male or female
- Age ≥ 18 years old
- Pathological confirmation of esophageal squamous cell carcinoma
- Endoscopic ultrasound, enhanced CT scan of the neck, chest, and abdomen, and esophageal magnetic resonance imaging evaluate as T3 or resectable T4 PET/CT、 Cervical, thoracic, and abdominal enhanced CT evaluation of N0...
- No clear distant metastasis (M0) and only cervical or supraclavicular lymph node metastasis (M1a)
- Tumor longitudinal diameter ≤ 10cm
- The tumor did not involve the dentate line
- ECOG score 0 or 1
- No hematological diseases, no liver or kidney dysfunction
- Absolute neutrophil count ≥ 1.5 × 109/L
- Platelets ≥ 100 × 109/L
- Hemoglobin ≥ 11g/L
- ALT ≤ 2 times the upper limit of normal value
- TBil ≤ 1.5 times the upper limit of normal value
- Creatinine clearance rate (Cockroft) ≥ 50ml/min
- Obtain informed consent
- T staging evaluation is T1/T2
- PET/CT and other evaluations show distant metastasis (M1)
- Planned pregnancy or patients during pregnancy or lactation
- History of previous chemotherapy, radiation therapy, or immunotherapy
- Previous severe coronary heart disease and heart failure (NYHA grade III/IV)
- Previous pulmonary interstitial fibrosis or severe pulmonary dysfunction that cannot tolerate surgery
- Previous autoimmune disease requiring systemic treatment within 2 years
- Previous immunodeficiency diseases or the need for systemic steroid replacement therapy
- Previous motor or sensory neurotoxic diseases
- Previous mental illness
- Potential diseases that may affect patients' ability to receive planned treatment, such as drug allergies
- Acute infectious diseases requiring systemic treatment
- Previous HIV, HBV, or HCV infections
- Previously received stem cell or solid organ transplantation
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.