Neoadjuvant Chemoradiotherapy Combined With CTLA-4 Monoclonal Antibody Plus PD-1 Monoclonal Antibody for Locally Advanced Esophageal Cancer

Recruiting now · Phase 2

Conditions studied: Esophageal Squamous Cell Carcinoma (ESCC)

In brief

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.

Key facts

Study ID

NCT07751055

Run by

Sun Yat-sen University

People needed

51

Starts

2026-08-01

Expected to finish

2030-12-31

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed resectable thoracic esophageal squamous cell carcinoma (ESCC); pretreatment clinical stage of T1-4aN1-3M0 or T3-4aN0M0 per the 8th edition of UICC staging system.
• Treatment-naive patients without prior anti-tumor therapy.
• Expected survival duration > 6 months.
• Aged between 18 and 75 years, either male or female.
• Adequate function of major vital organs meeting the following laboratory criteria:
• White blood cell (WBC) ≥4.0×10⁹/L; absolute neutrophil count (ANC) ≥1.5×10⁹/L;
• Platelet count ≥100×10⁹/L;
• Hemoglobin ≥9 g/dL;
• Serum albumin ≥2.8 g/dL;
• Total bilirubin ≤1.5 × ULN; ALT, AST and/or ALP ≤2.5 × ULN;
• Serum creatinine ≤1.5 × ULN, or creatinine clearance >60 mL/min.
• Eastern Cooperative Oncology Group (ECOG) PS score: 0-1.
• Capable of understanding the study protocol and signing written informed consent.
• Absence of severe complications including active massive gastrointestinal hemorrhage, perforation, jaundice, bowel obstruction, or non-malignant fever >38℃.
• Female and male patients of childbearing potential must use effective contraception throughout relevant study period.
• Good treatment compliance and availability for scheduled follow-up of efficacy and adverse events per study protocol.

You may not qualify if…

• Patients who have received prior anti-tumor therapies including chemotherapy, radiotherapy, surgery, immunotherapy, etc.
• Patients with known or suspected hypersensitivity to any components of CTLA-4 inhibitors, sintilimab or other monoclonal antibodies, as well as chemotherapeutic agents (nab-paclitaxel and cisplatin).
• Patients with pre-existing hemorrhagic disorders.
• Patients with unresectable disease due to other uncontrollable conditions.
• Female patients who are pregnant or breastfeeding.
• Patients lacking capacity to provide informed consent due to psychological, familial or social reasons.
• Patients with peripheral neuropathy graded ≥ Grade 2 per CTCAE criteria.
• Patients with a prior history of other malignancies besides esophageal cancer, except for non-melanoma skin cancer, cervical carcinoma in situ, or previously cured early-stage prostate cancer.
• Patients with more than 10 years of diabetes mellitus and poorly controlled blood glucose.
• Patients with severe impairment of cardiac, pulmonary, hepatic or renal function, hematological diseases or cachexia that preclude tolerance to chemotherapy, radiotherapy or surgery.
• Patients with active or past history of autoimmune diseases (including but not limited to colitis, hepatitis, hyperthyroidism), or history of immunodeficiency diseases (HIV positive, other acquired or congenital immunodeficiency disorders), or previous history of solid organ or allogeneic hematopoietic stem cell transplantation.
• Patients with prior history of interstitial lung disease or non-infectious pneumonia.
• Subjects with active hepatitis B (HBV DNA ≥ 2000 IU/mL or 10⁴ copies/mL) or active hepatitis C (HCV antibody positive with HCV-RNA above the lower limit of quantification of the assay).

Where it is running

• No.651 Dongfeng East Road,Guangzhou — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.