RecruitingPhase 2Phase 3NCT06907602

Optimizing Neoadjuvant Treatment Regimens for Locally Advanced Esophageal Squamous Cell Carcinoma

Optimizing Neoadjuvant Treatment Regimens for Locally Advanced Esophageal Squamous Cell Carcinoma: A Phase II Clinical Study


Sponsor

Peking Union Medical College Hospital

Enrollment

120 participants

Start Date

Jan 12, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing different combinations of chemotherapy and immunotherapy given before surgery (neoadjuvant treatment) for people with locally advanced cancer of the esophagus (food pipe), specifically the squamous cell type, to see which combination is most effective. **You may be eligible if...** - You are 18 or older - You have been diagnosed with esophageal squamous cell carcinoma confirmed by biopsy - Your cancer is locally advanced but has not clearly spread to distant organs - Your tumor is 10 cm or shorter - You are in good overall health (ECOG 0 or 1) - Your blood counts, liver, and kidney function are within acceptable ranges **You may NOT be eligible if...** - Your cancer has clearly spread to distant organs (other than limited lymph node involvement) - Your tumor is longer than 10 cm or involves certain areas of the esophagus - Your blood counts or organ function are too low Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGChemotherapy

carboplatin plus nab-paclitaxel

DRUGImmunotherapy (Pembrolizumab)

Pembrolizumab

RADIATIONradiotherapy

40-45Gy/20fx,5 times a week


Locations(1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

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NCT06907602


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