Short-course Radiotherapy Combined With Serplulimab and Chemotherapy as Neoadjuvant Treatment for… (NCT07403435) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Short-course Radiotherapy Combined With Serplulimab and Chemotherapy as Neoadjuvant Treatment for Resectable ESCC
China22 participantsStarted 2026-02-15
Plain-language summary
This study includes patients with resectable esophageal squamous cell carcinoma who will undergo local radiotherapy (PTV: 1.5Gy Bid, for 5 days), followed by neoadjuvant treatment with Serplulimab combined with cisplatin and paclitaxel for three cycles. Afterward, they will undergo surgery. Postoperatively, researchers will select adjuvant treatment plans based on the patients' conditions.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Patients with histologically confirmed squamous cell carcinoma of the esophagus (ESCC) staged as cT1-2N+M0 and cT3NanyM0 (AJCC 8th edition);
✓. Aged between 18-75 years;
✓. ECOG performance status score of 0-1;
✓. The following laboratory tests confirm that the bone marrow, liver and kidney functions meet the requirements for study participation
✓. Hemoglobin ≥90g/L; ANC≥1.5×10\^9/L;platelet count ≥100×10\^9/L (patients must not have received blood transfusion or growth factor support within 14 days of blood sample collection);
✕. History of other malignancies in the past or concurrently, except for cured basal cell carcinoma of the skin and in situ cervical carcinoma; patients with small gastric stromal tumors and other tumors judged by the investigator to not affect the patient's life in the short term may be excluded;
✕. Participation in other drug clinical trials within four weeks;
✕. Patients with any active autoimmune disease or history of autoimmune disease (e.g., but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaryitis, vasculitis, nephritis, hyperthyroidism; patients with vitiligo; asthma that was completely resolved in childhood and does not require any intervention in adulthood may be included; asthma requiring medical intervention with bronchodilators cannot be included);
What they're measuring
1
pCR（Pathological Complete Response）
Timeframe: within 14 working days after operation
Trial details
NCT IDNCT07403435
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
✕. Patients currently using immunosuppressants, or systemic corticosteroid therapy for immunosuppressive purposes (dose \>10mg/day prednisone or other equivalent corticosteroids), and continued use within two weeks prior to enrollment;
✕. Any active malignant tumor within two years, except for the specific cancer being studied in this trial and cured locally recurrent cancer (e.g., resected basal cell or squamous cell skin cancer, superficial bladder cancer, in situ cervical or breast carcinoma);
✕. Patients with known central nervous system (CNS) metastasis or history of CNS metastasis at screening. For patients clinically suspected of CNS metastasis, a CT or MRI examination must be performed within 28 days before treatment to rule out CNS metastasis;
✕. History of unstable angina; newly diagnosed angina within three months before screening or myocardial infarction event within six months before screening; arrhythmia (including QTcF: males ≥450 ms, females ≥470 ms) requiring long-term antiarrhythmic medication and New York Heart Association class ≥II heart failure;
✕. Urine routine indicating proteinuria ≥++ and confirmed 24-hour urinary protein \>1.0 g;