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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Contact Information
Primary
Li Li
Lili4037@pumch.cn
+86-10-69152630
Time Frame
Start Date: 2024-01-12
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 120
Treatments
Experimental: 2 cycles chemoimmunotherapy plus surgery
2 cycles chemoimmunotherapy and surgery
Experimental: 4 cycles chemoimmunotherapy plus surgery
4 cycles chemoimmunotherapy and surgery
Experimental: 4 cycles chemoimmunotherapy plus radiotherapy and surgery
4 cycles chemoimmunotherapy plus radiotherapy and surgery
Related Therapeutic Areas
Sponsors
Collaborators: Peking University Cancer Hospital & Institute, Military 301 Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Leads: Peking Union Medical College Hospital

This content was sourced from clinicaltrials.gov

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