Toripalimab With Preoperative Chemoradiotherapy for LA-EGJ

The Combination of Toripalimab With Preoperative Chemoradiotherapy for Locally Advanced Adenocarcinoma of Esophagogastric Junction

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gastroesophageal Junction Cancer; Chemoradiotherapy; PD-1
• Intervention / Treatment: Drug: PD-1

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 Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Jianhao Geng, MD; Phone Number: +86-18500227857; Email: gengjh3@sina.com
• Study Contact Backup: Name: Ziyu Li, MD; Phone Number: +86-13901009767; Email: ziyu_li@hsc.pku.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 1) Age 18-75, male and female.

  2) ECOG score was 0-1.

  3) Diagnosis of adenocarcinoma in the gastroesophageal junction.

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

  5) The estimated survival time will be more than 12 months.

  6) Adequate organ reserve function.

  7) 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.

  2) Immunosuppressive drugs were used within 4 weeks before admission.

  3) 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.

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TRG (Tumor Regression Grading)	The TRG of operation after neoadjuvant chemoradiotherapy and immunotherapy.	10 days after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with AEs (Adverse Events)	The AEs during the trial, including radiation mucositis, bone marrow suppression, AEs related to immunotherapy and so on	Through study completion, an average of 1 year
LC (Local Control)	The local control of the patients	Through study completion, an average of 1 year
DFS (Disease Free Survival)	The disease free survival of the patients	Through study completion, an average of 1 year

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): August 26, 2019
• Primary Completion (Anticipated): August 25, 2022
• Study Completion (Anticipated): August 25, 2023

Study Registration Dates

• First Submitted: August 1, 2019
• First Submitted That Met QC Criteria: August 17, 2019
• First Posted (Actual): August 20, 2019

Study Record Updates

• Last Update Posted (Actual): August 20, 2019
• Last Update Submitted That Met QC Criteria: August 17, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2019YJZ38

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No