Esophageal Squamous Cell Cancer
Conditions
Interventions
Group A: patients without measurable lesion:Serplulimab combined with chemotherapy
Group A: patients with measurable lesions:Serplulimab combined with chemotherapy
Sponsors
National Cancer Center/Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Male and female patients aged =18 years, =75 years. 2.Histologically or cytologically confirmed esophageal squamous cell carcinoma. 3.Advanced disease (T1b-T2, N+or T3-T4a, Nany, M0 or M1 lymph node metastasis (confined to the supraclavicular lymph nodes)). 4.No prior treatment for this disease. 5.Eastern cooperative oncology group (ECOG) performance status of 0 to 1. 6.Subjects had no major organ dysfunction, and the investigators assessed thyroid, lung, liver, kidney function, and cardiac function as normal. 7.Normal coagulation function, no active bleeding or thrombotic disease. 8.Women of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days prior to enrollment and voluntarily use an appropriate method of contraception during the observation period and for 8 weeks after the last dose of the study drug; For men, they should be surgically sterilized or agree to use an appropriate method of contraception during the observation period and for 8 weeks after the last dose of the study drug. 9.Subjects voluntarily joined the study and signed informed consent. 10.Subjects have sufficient tissue samples and consent to have their tissue samples and blood samples used for study analysis. 11.Patients are expected to have good compliance and be able to follow up on efficacy and adverse effects as required by the protocol.
Exclusion criteria
Exclusion criteria: 1.A history of gastrointestinal perforation and/or fistula within 6 months prior to the first administration; 2.Obvious invasion of tumor into adjacent organs (aorta or trachea) of esophageal lesions leads to high risk of bleeding or fistula; 3.Subjects after endotracheal stent implantation; 4.Other malignancies diagnosed within 5 years prior to first administration of study drug, except effectively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or effectively resected in situ cervical and/or breast cancer; 5.Have any active autoimmune disease or history of autoimmune disease; 6.Suffering from congenital or acquired immune deficiency; 7.Subjects who received immunosuppressive agents within 14 days prior to the first dose; 8.Live attenuated vaccine administered within 4 weeks prior to the first dose or planned during the study period; 9.Have an uncontrolled cardiac clinical condition or disease; 10.Complicated severe infection within 4 weeks prior to first dose; 11.Subjects with past or current interstitial pneumonia, pneumoconiosis, drug-related pneumonia, or severe impairment of lung function; 12.Patients with active tuberculosis infection; 13.Major surgery, open biopsy or significant trauma within 28 days prior to enrollment; 14.Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 15.People with thrombosis-like diseases or treated with anticoagulant drugs; 16.Pregnant or breastfeeding women; patients of childbearing potential who are unwilling or unable to use effective contraception; 17.Other conditions deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical complete response (cCR) rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate, ORR;Safety; | — |
Countries
China
Contacts
Public ContactJing Huang
National Cancer Center/Chinese Academy of Medical Sciences
Outcome results
None listed