Clincosm LogoSign in Get a demo

Toripalimab With Preoperative Chemoradiotherapy for LA-EGJ

Sponsor
Peking University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04061928
Collaborator
(none)
45
Enrollment
1
Arm
48
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This study aims to investigate the safety and efficacy of radiotherapy combined with Toripalimab (PD-1 inhibitor) in the treatment of locally advanced adenocarcinoma of the gastroesophageal junction.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Detailed Description

In this study, patients with locally advanced adenocarcinoma of gastroesophageal junction will be enrolled to explore the safety and efficacy of preoperative radiotherapy and chemotherapy combined with Toripalimab (PD-1). Around 45 patients will be recruited in this one-arm cohort. All patients in this cohort will be treated with preoperative radiotherapy and chemotherapy plus PD-1 for two times, then another two times of PD-1 before operation. After surgery, postoperative chemotherapy plus PD-1 will be carried out for four times. This study focuses on the safety of chemoradiotherapy combined with immunotherapy, and whether the TRG grade, LC, DFS have been improved.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Combination of Toripalimab With Preoperative Chemoradiotherapy for Locally Advanced Adenocarcinoma of Esophagogastric Junction
Anticipated Study Start Date :
Aug 26, 2019
Anticipated Primary Completion Date :
Aug 25, 2022
Anticipated Study Completion Date :
Aug 25, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Combination of toripalimab with preoperative chemoradiotherapy

This is a one arm study, enrolled locally advanced EGJ patients will receive toripalimab and combined with preoperative chemoradiotherapy and operation. generic name：PD-1 dosage form：Injection dosage：240mg (6ml) frequency：every 3 weeks duration：4 times before operation and 4 times after operation

Drug: PD-1
2 times PD-1 (240mg) combined with preoperative chemoradiotherapy，then another 2 times PD-1 before operation. 4 times PD-1 combined with postoperative chemotherapy.
Other Names:
  • Toripalimab

    		•

    Outcome Measures

    Primary Outcome Measures

    1. TRG (Tumor Regression Grading) [10 days after operation]

      The TRG of operation after neoadjuvant chemoradiotherapy and immunotherapy.

    Secondary Outcome Measures

    1. Number of participants with AEs (Adverse Events) [Through study completion, an average of 1 year]

      The AEs during the trial, including radiation mucositis, bone marrow suppression, AEs related to immunotherapy and so on

    2. LC (Local Control) [Through study completion, an average of 1 year]

      The local control of the patients

    3. DFS (Disease Free Survival) [Through study completion, an average of 1 year]

      The disease free survival of the patients

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
      1. Age 18-75, male and female.

    1. ECOG score was 0-1.

    2. Diagnosis of adenocarcinoma in the gastroesophageal junction.

    3. Initial treatment of locally advanced patients (cT3-4 or N+, and M0).

    4. The estimated survival time will be more than 12 months.

    5. Adequate organ reserve function.

    6. agree to join the group, willing to cooperate with clinical research, and sign the informed consent.

    Exclusion Criteria:
      1. Patients have received immunotherapy, such as PD-1 antibody, PD-L1 antibody and CTLA4 antibody.

    1. Immunosuppressive drugs were used within 4 weeks before admission.

    2. Active infection, acute myocardial infarction in recent 6 months, severe arrhythmia requiring long-term drug intervention, severe stroke, uncontrolled epilepsy or other serious medical complications.

    3. In the past five years, there have been other malignant diseases except for cured skin cancer and cervical cancer in situ.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Peking University

    Investigators

    • Principal Investigator: Ziyu Li, MD, Peking University Cancer Hospital & Institute
    • Principal Investigator: Yongheng Li, MD, Peking University Cancer Hospital & Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ziyu Li, MD, The director of ward 1 of gastrointestinal tumor center, Peking University
    ClinicalTrials.gov Identifier:
    NCT04061928
    Other Study ID Numbers:
    • 2019YJZ38
    First Posted:
    Aug 20, 2019
    Last Update Posted:
    Aug 20, 2019
    Last Verified:
    Aug 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Aug 20, 2019