Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Location status: Recruiting
NCT Number: NCT06907602
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2 / Phase 3
Beijing, Beijing Municipality, 100730, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
carboplatin plus nab-paclitaxel
Pembrolizumab
40-45Gy/20fx,5 times a week
Time frame: After surgery
Postoperative pathology according to CAP classification.
Time frame: 2 years and 5 years after therapy
overall survival after 2 years and 5 years
Time frame: 1 years after therapy
Adverse effect according to CTCAE and RTOG criteria
Time frame: After surgery
Time frame: After surgery
postoperative complications according to Clavien-Dindo classification
Time frame: 2 years and 5 years after therapy
disease-free survival after 2 years and 5 years
Contact information is provided by the study sponsor or research team.
Peking Union Medical College Hospital
Other
Optimizing Neoadjuvant Treatment Regimens for Locally Advanced Esophageal Squamous Cell Carcinoma: A Phase II Clinical Study
Acronym: ONTRESCC
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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