DCRT vs. Surgery in Resectable ESCC Patient Achiving cCR/PR After nCI (NCT07162506) | Clinical Trial Compass
RecruitingPhase 2
DCRT vs. Surgery in Resectable ESCC Patient Achiving cCR/PR After nCI
China120 participantsStarted 2025-08-01
Plain-language summary
This is a single-center, Phase II clinical study aiming to evaluate the efficacy, safety, and organ preservation feasibility of definitive concurrent chemoradiotherapy versus surgery in patients with locally advanced resectable esophageal squamous cell carcinoma (ESCC) who achieve clinical complete response/partial response (cCR/PR) after neoadjuvant camrelizumab combined with chemotherapy.
A total of 120 eligible subjects will be enrolled. Patients with cCR/PR after 2 cycles of induction chemoimmunotherapy (camrelizumab + nab-paclitaxel + carboplatin) will be grouped based on personal willing: the control group (n=60) will receive radical esophagectomy + mediastinal lymph node dissection; the experimental group (n=60) will receive definitive concurrent chemoradiotherapy (radiotherapy: 50.4 Gy/28f; chemotherapy: nab-paclitaxel 175mg/m² + carboplatin AUC=5, q21d for 2 cycles). All the patients will receive camrelizumab maintenance therapy (200mg q21d) up to 1 year.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Volunteered to participate, cooperated with follow-up visits.
✓. Aged 18 - 75 years (inclusive), male or female.
✓. Histologically confirmed locally advanced resectable ESCC, clinically staged as Stage II - IVa (cT1N1-3M0, cT2-4aN0-3M0 before treatment; 8th AJCC), and achieve cCR/PR after 2 cycles of camrelizumab combined with nab-paclitaxel and carboplatin.
✓. Presence of measurable and/or non-measurable lesions as defined by Japanese Classification of Esophageal Cancer (12th Edition);
✓. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
✓. Estimated survival time ≥ 3 months.
✓. The function of major organs meets the following requirements: