Neoadjuvant Chemoradiotherapy Combined With PD-1 Antibody in Locally Advanced Esophageal Cancer

• Status: Recruiting
• Trial end date: 2022-04-30
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety and feasibility of preoperative immune checkpoint therapy with concurrent Chemoradiotherapy in patients with locally advanced esophageal squamous cell carcinoma. And this study will provide valuable information for further clinical trials of preoperative Teripalimab and other immune checkpoint therapy in esophageal cancer treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Tongji Hospital
• Treatments: Albumin-Bound Paclitaxel; Antibodies; Cisplatin; Docetaxel; Immunoglobulins; Paclitaxel

Criteria

Inclusion Criteria:

• Age 18-70, male or female

• Locally advanced esophageal cancer diagnosed by pathology, Clinical tumor stage should be T2-3N0-1M0

• No previous chemoradiotherapy

• Have a performance status of 0 or 1 on the ECOG Performance Scale

• Demonstrate adequate organ function as defined below (excluding the use of any blood components and cytokines during the screening period)

• Absolute neutrophil count (ANC) ≥1.5*109 /L; Platelet ≥90*109/L; Hemoglobin ≥ 9 g/dL; Serum albumin≥3g/dL

• Bilirubin≤1.5 x ULN; ALT and AST≤2.5 ULN; Serum creatinine ≤1.5 x ULN or creatinine clearance ≥40mL/min

• Female subject must have taken reliable contraceptive measures of childbearing potential should have a negative urine or serum pregnancy within 7 days prior to receiving the first dose of study medication. and be willing to use an appropriate method of contraception during the trial and 8 weeks after the last administration of the test drug. Male subject should agree to use appropriate contraceptive methods or to have been surgically sterilized during the trial and 8 weeks after the last administration of the test drug.

• Subjects voluntarily participated in this study and signed the informed consent, with good compliance and follow-up.

Exclusion Criteria:

• Any active autoimmune disease or history of autoimmune disease (as follows, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitritis, vasculitis, nephritis, hyperthyroidism, thyroid dysfunction);Subjects with vitiligo or who have had complete remission from childhood asthma without any intervention after adulthood may be included; Asthma requiring medical intervention with bronchodilators was not included. Those who have used other drugs in clinical trials to study drugs within 4 weeks before their first use;

• Severe allergic reaction to monoclonal antibody

• The number of neutrophils in peripheral blood was lower than 1500/mm3;

• There are clinical symptoms or diseases of the heart that are not well controlled, such as: A. heart failure above grade 2 by the Criteria of NYHA; B. unstable angina pectoris; C. myocardial infarction occurred within 1 year; D. Clinically meaningful supraventricular or ventricular arrhythmias require treatment or intervention;

• Has a previous radiotherapy, chemotherapy, hormone therapy, surgery or molecular targeted therapy;

• Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). or Has known active Hepatitis B (e.g. HBV DNA≥ 2000IU/ml or copy number ≥104/ml;) or Hepatitis C (e.g. HCV antibody positive).

• According to the judgment of the researchers, the subjects have other factors that may cause the forced termination of the study, such as other serious diseases (including mental diseases) requiring combined treatment, severe laboratory examination abnormalities, accompanied by family or social factors, which may affect the safety of the subjects, or the collection of data and samples.

• The researchers determined patients with high risk of esophageal perforation or no potential surgical feasibility through endoscopic ultrasonography or imaging examination.