Toripalimab With Preoperative Chemoradiotherapy for LA-EGJ

Chemoradiotherapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04061928
• Other study ID #: 2019YJZ38
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: August 26, 2019
• Est. completion date: August 25, 2023

Study information

• Verified date: August 2019
• Source: Peking University
• Contact: Jianhao Geng, MD
• Phone: +86-18500227857
• Email: gengjh3[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: August 25, 2023
• Est. primary completion date: August 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chemoradiotherapy
• Gastroesophageal Junction Cancer
• PD-1

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TRG (Tumor Regression Grading)	The TRG of operation after neoadjuvant chemoradiotherapy and immunotherapy.	10 days after operation
Secondary	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
Secondary	LC (Local Control)	The local control of the patients	Through study completion, an average of 1 year
Secondary	DFS (Disease Free Survival)	The disease free survival of the patients	Through study completion, an average of 1 year