Optimizing Neoadjuvant Treatment Regimens for Locally Advanced Esophageal Squamous Cell Carcinoma
ONTRESCC
1 other identifier
interventional
120
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2024
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 12, 2024
CompletedFirst Submitted
Initial submission to the registry
March 27, 2025
CompletedFirst Posted
Study publicly available on registry
April 2, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
April 2, 2025
March 1, 2025
3 years
March 27, 2025
March 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Pathological response
Postoperative pathology according to CAP classification.
After surgery
2-year and 5-year overall survival
overall survival after 2 years and 5 years
2 years and 5 years after therapy
Secondary Outcomes (4)
Adverse effect incidence
1 years after therapy
R0 resection rate
After surgery
postoperative complications
After surgery
2-year and 5-year disease-free survival
2 years and 5 years after therapy
Study Arms (3)
2 cycles chemoimmunotherapy plus surgery
EXPERIMENTAL2 cycles chemoimmunotherapy and surgery
4 cycles chemoimmunotherapy plus surgery
EXPERIMENTAL4 cycles chemoimmunotherapy and surgery
4 cycles chemoimmunotherapy plus radiotherapy and surgery
EXPERIMENTAL4 cycles chemoimmunotherapy plus radiotherapy and surgery
Interventions
carboplatin plus nab-paclitaxel
Pembrolizumab
40-45Gy/20fx，5 times a week
Eligibility Criteria
You may qualify 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 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
- +1 more criteria
You may not qualify 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2025
First Posted
April 2, 2025
Study Start
January 12, 2024
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2028
Last Updated
April 2, 2025
Record last verified: 2025-03