Optimizing Neoadjuvant Treatment Regimens for Locally Advanced Esophageal Squamous Cell Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Chemotherapy, Immunotherapy (Pembrolizumab), radiotherapy.
- Who it may be relevant to
- Registry conditions: Locally Advanced Esophageal Squamous Cell Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Optimizing Neoadjuvant Treatment Regimens for Locally Advanced Esophageal Squamous Cell Carcinoma: A Phase II Clinical Study
Overview
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. Meanwhile, no severe adverse drug reactions have been found in terms of safety, so this treatment regimen is safe and reliable. However, the cycle of neoadjuvant immunotherapy is still under exploration. Currently, the mainstream research centers adopt a regimen of 2 to 4 cycles. The exploration results of our center have found that most patients' conditions can be further alleviated after 4 cycles compared with after 2 cycles, but there are still a small number of patients with no obvious remission. Therefore, we consider observing whether patients with no obvious remission can achieve a better pathological response rate through further radiotherapy.
Interventions
- Drug Chemotherapy
carboplatin plus nab-paclitaxel - Drug Immunotherapy (Pembrolizumab)
Pembrolizumab - Radiation radiotherapy
40-45Gy/20fx，5 times a week
Primary outcome measures
- Pathological response [Time frame: After surgery]
- 2-year and 5-year overall survival [Time frame: 2 years and 5 years after therapy]
Secondary outcome measures (4)
- Adverse effect incidence [Time frame: 1 years after therapy]
- R0 resection rate [Time frame: After surgery]
- postoperative complications [Time frame: After surgery]
- 2-year and 5-year disease-free survival [Time frame: 2 years and 5 years after therapy]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking Union Medical College Hospital — Beijing
Identifiers
NCT: NCT06907602 · Keypoint 002