OncoMatch/Clinical Trials/NCT07751055
Neoadjuvant Chemoradiotherapy Combined With CTLA-4 Monoclonal Antibody Plus PD-1 Monoclonal Antibody for Locally Advanced Esophageal Cancer
Is NCT07751055 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies multiple treatments including Ipilimumab (1mg/kg) and Sinitilimab for esophageal squamous cell carcinoma (escc).
Treatment: Ipilimumab (1mg/kg) · Sinitilimab · Nab-paclitaxel + Cisplatin — This is a prospective, single-arm phase II clinical trial intended to investigate the efficacy of neoadjuvant CTLA-4 monoclonal antibody combined with PD-1 monoclonal antibody plus preoperative chemoradiotherapy for locally advanced esophageal cancer. A total of 44 patients with resectable esophageal squamous cell carcinoma (ESCC) will be enrolled.All enrolled subjects will receive induction therapy with the combination of a CTLA-4 inhibitor and a PD-1 inhibitor. Three weeks afterwards, patients will transition to concurrent chemoradiotherapy combined with PD-1 inhibitor. Intensity-modulated radiotherapy (IMRT) will be delivered at a total dose of 40 Gy in 20 fractions. Radical esophagectomy with two-field thoracic and abdominal lymph node dissection will be performed 6-8 weeks after completion of chemoradiotherapy.The primary objective of this trial is to evaluate the efficacy and safety of the triplet regimen consisting of CTLA-4 inhibitor plus PD-1 inhibitor combined with preoperative chemoradiotherapy in locally advanced esophageal cancer, so as to further optimize the multimodal therapeutic strategy for esophageal cancer.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Cancer type
Esophageal Carcinoma
Disease stage
Required: Stage T1-4AN1-3M0, T3-4AN0M0 (other)
pretreatment clinical stage of T1-4aN1-3M0 or T3-4aN0M0 per the 8th edition of UICC staging system
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: anti-tumor therapy
Treatment-naive patients without prior anti-tumor therapy
Lab requirements
Blood counts
WBC ≥4.0×10⁹/L; ANC ≥1.5×10⁹/L; Platelet count ≥100×10⁹/L; Hemoglobin ≥9 g/dL; Serum albumin ≥2.8 g/dL
Kidney function
Serum creatinine ≤1.5 × ULN, or creatinine clearance >60 mL/min
Liver function
Total bilirubin ≤1.5 × ULN; ALT, AST and/or ALP ≤2.5 × ULN
Cardiac function
Severe impairment of cardiac function that precludes tolerance to chemotherapy, radiotherapy or surgery [excluded]
Adequate function of major vital organs meeting the following laboratory criteria: ... Severe impairment of cardiac, pulmonary, hepatic or renal function ... that preclude tolerance to chemotherapy, radiotherapy or surgery [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07751055 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
What disease stage is eligible?
Stage T1-4AN1-3M0 or T3-4AN0M0 is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages