Neoadjuvant Treatment of Toripalimab Combined With Nab-paclitaxel and Platinum Versus Neoadjuvant… (NCT06952621) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Neoadjuvant Treatment of Toripalimab Combined With Nab-paclitaxel and Platinum Versus Neoadjuvant Docetaxel Combined With Cisplatin and 5-fluorouracil (DCF) in Esophageal Squamous Cell Carcinoma
China390 participantsStarted 2026-02-01
Plain-language summary
This study is a randomized, controlled, open-label, multicenter Phase III clinical trial, designed to evaluate the efficacy and safety of neoadjuvant toripalimab in combination with nab-paclitaxel and platinum versus neoadjuvant docetaxel in combination with cisplatin and 5-fluorouracil (DCF) in the treatment of resectable locally advanced esophageal squamous cell carcinoma
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Voluntarily sign the written informed consent form;
✓. Age 18-75 years, inclusive of 18 and 75 years, both male and female;
✓. Life expectancy of ≥3 months;
✓. Expected to achieve R0 resection;
✓. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
✓. Patients with resectable locally advanced (T1 N1-3 M0 or T2-4a N0-3 M0 (T2≥3cm or poorly differentiated)) thoracic esophageal squamous cell carcinoma confirmed by histology and who have not previously received treatment;
✓. No suspicious metastatic lymph nodes in the neck (excluding regional lymph nodes in the upper thoracic esophageal cancer area) as suggested by neck ultrasound or enhanced CT, and no systemic metastasis detected by imaging studies;
✓. Presence of a definite tumor lesion;
Exclusion criteria
✕. Previous treatment with PD-1/PD-L1 agents or drugs targeting another T-cell receptor (e.g., CTLA-4, OX-40, etc.);
✕. Presence of uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
✕. Active autoimmune disease or suspicion of such, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, etc., with the exception of type 1 diabetes and hypothyroidism controlled with stable-dose replacement therapy, and skin diseases not requiring systemic treatment (e.g., psoriasis, vitiligo);
What they're measuring
1
Pathological complete response rate (pCR)
Timeframe: Pathological detection after surgery within 1 month
✕. History of interstitial lung disease ≥ Grade 2;
✕. Received systemic corticosteroids (prednisone \>10mg/day or equivalent) or other immunosuppressive drugs within 14 days prior to the first study drug administration;
✕. History of immunodeficiency, including other acquired or congenital immunodeficiency diseases, history of organ transplantation, or having undergone allogeneic hematopoietic stem cell transplantation or solid organ transplantation;
✕. Received live vaccine within 4 weeks prior to the first study drug administration;
✕. Presence of severe cardiovascular and cerebrovascular diseases: