Status:
RECRUITING
PD-1 Inhibitor Combined With Neoadjuvant Chemoradiotherapy Plus Surgery for Locally Advanced ESCC (NEOCRTEC2101)
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Affiliated Cancer Hospital of Shantou University Medical College
Conditions:
Squamous Cell Esophageal Carcinoma
Esophageal Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
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 s...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Patients have received any prior anticancer therapy.
- Patients are diagnosed or suspected to be allergic to sintilimab,toxal or cisplatin.
- Patients with concomitant hemorrhagic disease.
- Patients who cannot tolerate surgery.
- Pregnant or breast feeding.
- Patients without informed consent because of psychological, family, social or any other factors.
- Patients with concomitant peripheral neuropathy, whose CTC status is 2 or even more.
- 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 ).
Key Trial Info
Start Date :
November 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2031
Estimated Enrollment :
422 Patients enrolled
Trial Details
Trial ID
NCT05357846
Start Date
November 1 2022
End Date
January 31 2031
Last Update
June 12 2025
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060