About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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+
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Chemotherapy
Drugcarboplatin plus nab-paclitaxel
Immunotherapy (Pembrolizumab)
DrugPembrolizumab
radiotherapy
Radiation40-45Gy/20fx,5 times a week
Treatment groups
Trial outcomes
Primary outcomes
Pathological response
Postoperative pathology according to CAP classification.
2-year and 5-year overall survival
overall survival after 2 years and 5 years
Secondary outcomes
Adverse effect incidence
Adverse effect according to CTCAE and RTOG criteria
R0 resection rate
postoperative complications
postoperative complications according to Clavien-Dindo classification
2-year and 5-year disease-free survival
disease-free survival after 2 years and 5 years
Sponsors and contacts
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Peking Union Medical College Hospital
Lead sponsor
Military 301 Hospital
Collaborator
Peking University Cancer Hospital & Institute
Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborator