Toripalimab With Preoperative Chemoradiotherapy for LA-EGJ

NCT ID: NCT04061928

Last Updated: 2019-08-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-26
• Study Completion Date: 2023-08-25

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.

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.

Conditions

PD-1; Chemoradiotherapy; Gastroesophageal Junction Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

PD-1

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Toripalimab

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Ziyu Li, MD

The director of ward 1 of gastrointestinal tumor center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ziyu Li, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Yongheng Li, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Central Contacts

Jianhao Geng, MD

Role: CONTACT

gengjh3@sina.com

+86-18500227857

Ziyu Li, MD

Role: CONTACT

ziyu_li@hsc.pku.edu.cn

+86-13901009767

Other Identifiers

2019YJZ38

Identifier Type: -

Identifier Source: org_study_id