Toripalimab With Preoperative Chemoradiotherapy for LA-EGJ

NCT04061928 | Unknown Phase 1

• 1 other identifier: 2019YJZ38
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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.

Conditions

PD-1; Chemoradiotherapy; Gastroesophageal Junction Cancer

Outcome Measures

Primary Outcomes (1)

• TRG (Tumor Regression Grading)

  The TRG of operation after neoadjuvant chemoradiotherapy and immunotherapy.

  10 days after operation

Secondary Outcomes (3)

• Number of participants with AEs (Adverse Events)

  Through study completion, an average of 1 year

• LC (Local Control)

  Through study completion, an average of 1 year

• DFS (Disease Free Survival)

  Through study completion, an average of 1 year

Study Arms (1)

Combination of toripalimab with preoperative chemoradiotherapy

EXPERIMENTAL

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

Interventions

PD-1 DRUG

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.

Also known as: Toripalimab

Combination of toripalimab with preoperative chemoradiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Age 18-75, male and female.
• \) ECOG score was 0-1.
• \) Diagnosis of adenocarcinoma in the gastroesophageal junction.
• \) Initial treatment of locally advanced patients (cT3-4 or N+, and M0).
• \) The estimated survival time will be more than 12 months.
• \) Adequate organ reserve function.
• \) agree to join the group, willing to cooperate with clinical research, and sign the informed consent.

You may not qualify if:

• \) Patients have received immunotherapy, such as PD-1 antibody, PD-L1 antibody and CTLA4 antibody.
• \) Immunosuppressive drugs were used within 4 weeks before admission.
• \) 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.
• \) In the past five years, there have been other malignant diseases except for cured skin cancer and cervical cancer in situ.

Sponsors & Collaborators

• Peking University: lead

MeSH Terms

Interventions

toripalimab

Study Officials

• Ziyu Li, MD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

• Yongheng Li, MD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianhao Geng, MD

CONTACT

+86-18500227857; gengjh3@sina.com

Ziyu Li, MD

CONTACT

+86-13901009767; ziyu_li@hsc.pku.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The director of ward 1 of gastrointestinal tumor center

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: August 20, 2019
• Study Start: August 26, 2019
• Primary Completion: August 25, 2022
• Study Completion: August 25, 2023
• Last Updated: August 20, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share