NCT05357846RecruitingPhase 3
PD-1 Inhibitor Combined With Neoadjuvant Chemoradiotherapy Plus Surgery for Locally Advanced ESCC (NEOCRTEC2101)
Phase III Multicenter Randomized Controlled Trial of PD-1 Inhibitor Combined With Preoperative Concurrent Chemoradiotherapy and Surgery for Locally Advanced Esophageal Squamous Cell Carcinoma (NEOCRTEC2101)
Source: ClinicalTrials.gov · Last updated 30 Apr 2026
Brief summary (registry, in English)
The primary objective is to compare PD-1 inhibitor combined with preoperative chemoradiotherapy followed by surgery versus neo-adjuvant chemoradiotherapy followed by surgery, in terms of the overall survival time (OS) in patients with Stage T1-4aN1-3M0 or T3-4aN0M0 squamous cell esophageal carcinoma.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 422 (estimated)
- First submitted
- 22 Mar 2022
- Start date
- 1 Nov 2022
- Primary completion date
- 1 Jan 2031
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05357846
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 422
- From 1 Nov 2022 to the primary completion date, 1 Jan 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients have received any prior anticancer therapy.
- Patients with concomitant hemorrhagic disease.
- Patients who cannot tolerate surgery.
- Patients with concomitant peripheral neuropathy, whose CTC status is 2 or even more.
Other illness
- Patients are diagnosed or suspected to be allergic to sintilimab,toxal or cisplatin.
- Patients with malignant tumors other than esophageal cancer,except for non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer.
- Patients with history of diabetes over 10 years and unsatisfactory glycemic control.
- Patients with severe heart,lung,liver,renal dysfunction, hematopoietic system diseases, immune system diseases, cachexia or other diseases that lead to intolerance of chemoradiotherapy or surgery.
- Patients with history of autoimmune diseases, immunodeficiency, or organ and allogeneic bone marrow transplantation.
- Patients with history of interstitial lung disease or noninfectious pneumonia.
- Patients with active pulmonary tuberculosis infection, or a history of active pulmonary tuberculosis infection within one year before enrollment, or a history of active pulmonary tuberculosis infection more than one year ago without regular treatment.
- Patients with active hepatitis B ( HBV DNA ≥ 2000 IU / mL or 104 copies / mL ) or hepatitis C ( HCV antibody positive ).
Other
- Pregnant or breast feeding.
- Patients without informed consent because of psychological, family, social or any other factors.
Who the study is looking for
- Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage T1-4aN1-3M0 or T3-4aN0M0,which is potentially resectable.
- Patients must not have received any prior anticancer therapy.
- More than 6 months of expected survival.
- Age ranges from 18 to 70 years.
- Absolute white blood cells count ≥4.0×109/L, neutrophil ≥1.5×109/L, platelets ≥100.0×109/L, hemoglobin ≥90g/L, and normal functions of liver and kidney.
- WHO PS score 0-1
- Signed informed consent document on file.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.