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 (NICCE)

August 24, 2021 updated by: Zhang Ni, Tongji Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Hubei Provience
      • Wuhan, Hubei Provience, China, 430030
        • Recruiting
        • Tongji Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

In this clinical trial, patients with resectable thoracic esophageal squamous cell carcinoma can receive neoadjuvant immunotherapy and neoadjuvant chemotherapy before operation.

Description

Inclusion Criteria:

  • Age 18-70 Years old，
  • The clinical stage of esophageal cancer confirmed by pathology was cT（1-3）N（1-3）M0
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Neoadjuvant Immunotherapy (PD-1 / PD-L1) Combined With Chemotherapy
Procedure: Neoadjuvant Immunotherapy (PD-1 / PD-L1) Combined With Chemotherapy
Each patient will complete 2 cycles of neoadjuvant therapy. After evaluating the curative effect, decide whether to operate or not. Patients with and without surgery enter the survival follow-up period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathologic Complete Response
Time Frame: 2-5 years
According to the detection of pathological specimens after operation, no malignant tumor cells were detected, so the patient achieved complete pathological remission.
2-5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 2-5 years
The time from randomization to death from any cause.
2-5 years
Disease-free Survival
Time Frame: 2-5 years
The patient achieved CR (complete remission) and still had no probability of recurrence after treatment in 2-years.
2-5 years
Progression-Free-Survival
Time Frame: 2-5 years
The time between the beginning of treatment and the observation of disease progression or death from any cause.
2-5 years
Security
Time Frame: 2-5 years
The safety of drugs was evaluated from four aspects: adverse events, adverse reactions, serious adverse events and serious adverse reactions.
2-5 years
Objective Response Rate
Time Frame: 2-5 years
The proportion of patients whose tumor volume reduced to a predetermined value and could maintain the minimum time limit.
2-5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor markers
Time Frame: 2-5 years
Tumor markers refer to those characteristic bioactive substances that can be detected that can reflect the development stage of malignant tumor cells. In a narrow sense, tumor markers refer to bioactive substances synthesized, secreted and released into blood and / or body fluid by malignant tumor cells, including enzymes, hormones, proteins, metabolites and other substances, Their occurrence and changes are closely related to the growth, diffusion, occurrence and development of malignant tumors.
2-5 years
Intestinal flora
Time Frame: 2-5 years
Intestinal flora homeostasis is called the organ of human body. Intestinal flora homeostasis plays an important role in the life activities of the body. It has important physiological significance in promoting the digestion and absorption of host nutrients, maintaining the normal physiological function of intestine, regulating body immunity and antagonizing the colonization of pathogenic microorganisms.
2-5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tongji Hospital

Collaborators

National Natural Science Foundation of China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

August 24, 2021

First Submitted That Met QC Criteria

August 24, 2021

First Posted (Actual)

August 31, 2021

Study Record Updates

Last Update Posted (Actual)

August 31, 2021

Last Update Submitted That Met QC Criteria

August 24, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJ-IRB20210624

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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