Optimizing treatment for advanced esophageal cancer
Optimizing Neoadjuvant Treatment Regimens for Locally Advanced Esophageal Squamous Cell Carcinoma: A Phase II Clinical Study
PHASE2; PHASE3 · Peking Union Medical College Hospital · NCT06907602
This study is testing a new treatment plan that combines chemotherapy, immunotherapy, and radiotherapy to see if it can help people with advanced esophageal cancer feel better and improve their chances of recovery.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital (other) |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06907602 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to enhance neoadjuvant treatment regimens for patients with locally advanced esophageal squamous cell carcinoma by evaluating the efficacy and safety of a combination of chemotherapy, immunotherapy (Pembrolizumab), and radiotherapy. Building on previous findings that showed a significant pathological complete response rate, the study will explore the optimal number of immunotherapy cycles to maximize patient outcomes. Participants will undergo thorough evaluations to confirm their eligibility based on specific clinical criteria.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with confirmed locally advanced esophageal squamous cell carcinoma and no distant metastasis.
Not a fit: Patients with early-stage esophageal cancer or those with distant metastasis are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment outcomes and survival rates for patients with advanced esophageal cancer.
How similar studies have performed: Previous studies have shown promising results with similar neoadjuvant treatment approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 or N+ * 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 Exclusion Criteria: * 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
Where this trial is running
Beijing, Beijing Municipality
- Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (RECRUITING)
Study contacts
- Study coordinator: Li Li
- Email: Lili4037@pumch.cn
- Phone: +86-10-69152630
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Locally Advanced Esophageal Squamous Cell Carcinoma, esophageal squamous cell carcinoma, neoadjuvant chemoimmunotherapy, radiotherapy