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

NCT04177875 | Unknown Phase 2

• 1 other identifier: [2019]（S910）
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Esophagus Cancer

Keywords

neoadjuvant therapy；pd-1 antibody combined with Chemoradiotherapy

Outcome Measures

Primary Outcomes (2)

• Major Pathological Response Rate (MPR)

  No more than 10% of tumor cells were found in neoadjuvant surgical specimens.

  30 days after the second cycle of treatment(each cycle is 21 days)

• Objective Response Rate (ORR)

  Based on RECIST evaluation criteria, the proportion of patients with complete ORR was defined as the percentage of patients having a complete response or a partial response to protocol treatment. Objective response will be measured by RECIST 1.1.

  At the end of cycles 2(each cycle is 21 days)

Secondary Outcomes (4)

• 2-year Disease-Free Survival Rate (24 months DFS)

  2 years

• Media Disease-free Survival (mDFS)

  Up to 5 years

• Media overall survival (mOS)

  Up to 5 years

• The incidence of adverse events and the incidence of severe adverse events（ grade 3-4)

  60 days after the end protocol treatment

Study Arms (1)

Chemoradiation and pd-1

EXPERIMENTAL

Subjects in Arm A receive 2 cycles of Docetaxel /Albumin-bound Paclitaxel + Cisplatin, for neoadjuvant therapy Neoadjuvant radiotherapy for 40Gy/20F

Drug: Teripalimab

Interventions

Teripalimab DRUG

Teripalimab Injection 240mg/6ml fixed dose (3mg/kg for patients weighing less than 40kg) ,injection on day 1, each infusion for 30min (no less than 60 minutes for the first injection); every 3 weeks. docetaxel dose was 75mg/m2, injection on day 1;Albumin-bound Paclitaxel (no anti-allergic treatment required), 260mg/m2, injection on day 1; Cisplatin was 75mg/m2, injected on day 1.A total of two treatment cycles.

Also known as: Docetaxel /Albumin-bound Paclitaxel, Cisplatin

Chemoradiation and pd-1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Docetaxel; Albumin-Bound Paclitaxel; Cisplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Paclitaxel; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Li Zhang, MD

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Zhang, MD

CONTACT

86-13554191436; luzigang@163.com

yuan Chen

CONTACT

86-02783663407; chenyuan008@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 26, 2019
• Study Start: May 1, 2019
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2022
• Last Updated: November 26, 2019

Record last verified: 2019-05

Locations

CN (1)