Clinical trial · Interventional
Toripalimab With Preoperative Chemoradiotherapy for LA-EGJ
The Combination of Toripalimab With Preoperative Chemoradiotherapy for Locally Advanced Adenocarcinoma of Esophagogastric Junction
NCT04061928CI-TRIAL-00040150unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemoradiotherapy | — | UNRESOLVED | — |
| Gastroesophageal Junction Cancer | — | UNRESOLVED | — |
| PD-1 | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PD-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Combination of toripalimab with preoperative chemoradiotherapy
- description
- 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
- interventionNames
- Drug: PD-1
Primary outcomes (1)
- measure
- TRG (Tumor Regression Grading)
- timeFrame
- 10 days after operation
- description
- The TRG of operation after neoadjuvant chemoradiotherapy and immunotherapy.
Secondary outcomes (3)
- measure
- Number of participants with AEs (Adverse Events)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.