Neoadjuvant Immunotherapy (PD-1 / PD-L1) Combined With Chemotherapy for Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma: a Single Center Prospective Open One Arm Exploratory Clinical Study

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    46
  • sponsor
    Tongji Hospital
Updated on 7 September 2021
cancer
carcinoma
squamous cell carcinoma
chemoradiotherapy
neutrophil count
esophageal cancer
chemotherapy regimen
esophagus cancer

Summary

To purpose of this study is to access the safety and efficacy of neoadjuvant Immunotherapy (PD-1 / PD-L1) combined with chemotherapy for locally advanced thoracic esophageal squamous cellcarcinoma.

Description

Each patient will complete 2 cycles of neoadjuvant therapy and decide whether to operate after evaluating the curative effect if there is no active withdrawal of the subject from the trial or the researcher believes that the subject is not suitable for further trials. The patients after operation and without operation enter the survival follow-up period. If the imaging evaluation is PD after neoadjuvant therapy, the follow-up treatment shall be carried out according to the following principles: the imaging evaluation belongs to the continuous operation that can be operated; If the imaging evaluation was inoperable, radical concurrent radiotherapy and chemotherapy were performed. Postoperative adjuvant therapy shall be performed according to NCCN guidelines. If it is necessary to improve the local control rate, postoperative adjuvant radiotherapy is feasible. At the same time, imaging evaluation was performed until tumor recurrence and metastasis. After tumor recurrence and metastasis, all patients should also enter survival follow-up; In case of drug withdrawal (such as intolerable toxicity) other than recurrence and metastasis during treatment, the treatment is completed, the post-treatment visit is entered, and the survival follow-up is entered after recurrence.

Details
Condition Esophageal Squamous Cell Carcinoma, induction therapy, Squamous Cell Carcinoma of Esophagus, neoadjuvant treatment, Squamous Cell Carcinoma, Neoadjuvant Therapy, Squamous cell carcinoma, Esophageal Cancer
Treatment Neoadjuvant Immunotherapy (PD-1 / PD-L1) Combined With Chemotherapy
Clinical Study IdentifierNCT05028231
SponsorTongji Hospital
Last Modified on7 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18-70 Years old
The clinical stage of esophageal cancer confirmed by pathology was cT1-3N1-3M0
No previous chemoradiotherapy
ECOG PS: 0-1 points
The functions of important organs meet the following requirements (excluding the use of any blood components and cell growth factors during the screening period)Absolute neutrophil count 1.5 109/L Platelet 90 109/L Hemoglobin 9g / dl; Serum albumin 3G / dl; Thyroid stimulating hormone (TSH) ULN (if abnormal, the levels of T3 and T4 should be investigated at the same time. If the levels of T3 and T4 are normal, they can be included in the group); Bilirubin ULN; ALT and AST 1.5 times ULN; AKP 2.5 times ULN; Serum creatinine 1.5 times ULN or creatinine clearance 60ml / min
Women of childbearing age must have taken reliable contraceptive measures or conducted pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and are willing to use appropriate contraceptive methods during the test and 8 weeks after the last administration of test drugs. For men, they must agree to use appropriate methods of contraception or surgical sterilization during the trial and 8 weeks after the last administration of the trial drug
The patients voluntarily joined the study and signed the informed consent form. They had good compliance and cooperated with the follow-up

Exclusion Criteria

Any active autoimmune disease or history of autoimmunity (as follows, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism and hypothyroidism; Subjects with vitiligo or asthma in childhood have been completely relieved and do not need any intervention after adulthood can be included; Asthma in which subjects need bronchodilators for medical intervention cannot be included)
Those who have used other drugs in clinical trials within 4 weeks before the first medication
Severe allergic reaction to monoclonal antibody
The number of neutrophils in peripheral blood was less than 1500 / mm3
There are cardiac clinical symptoms or diseases that are not well controlled
Previously received radiotherapy, chemotherapy, hormone therapy, surgery or molecular targeted therapy
The subjects were innate or acquired immunodeficiency (such as HIV), or active hepatitis (hepatitis B reference: HBsAg) positive, HBVDNA > 2000IU/ml or copy number > 104/ml; Hepatitis C reference: HCV antibody positive
According to the judgment of the researcher, the subject has other factors that may lead to the forced midway termination of this study, such as other serious diseases (including mental diseases) requiring combined treatment, serious laboratory abnormalities, accompanied by family or social factors, which will affect the safety of the subject, or the collection of data and samples
The researchers judged the patients with high risk of esophageal perforation or no potential possibility of surgery through endoscopic ultrasonography or imaging
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