Clinical trial · Interventional
Combination of Radiation Therapy and Anti-PD-1 Antibody SHR-1210 in Treating Patients With Esophageal Cancer
Phase II Study of Radiation Therapy With Anti-PD-1 Antibody SHR-1210 in Treating Patients With Unresectable Esophageal Cancer
NCT03187314CI-TRIAL-00046660completedPhase 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)
The objective of this study is to evaluate the efficacy and safety of radiation therapy combined with anti-PD-1 antibody SHR-1210 in patients with esophageal cancer
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 |
|---|---|---|---|
| Esophageal Diseases | — | UNRESOLVED | — |
| Esophageal Neoplasms | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation | Drug | — | UNRESOLVED |
| SHR-1210 | Drug | Camrelizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental Group
- description
- Radiation to 60 Gy, 5 x per week, for 6 weeks. Radiation begun the day after the first dose of SHR-1210. SHR-1210 (200mg fixed dose every 2 weeks for 5 cycles) will be administered as an intravenous infusion over 60 minutes.
- interventionNames
- Drug: Radiation
- Drug: SHR-1210
Primary outcomes (1)
- measure
- Objective response rate (ORR)
- timeFrame
- 4-8 weeks
- description
- ORR was evaluated 4-8 weeks after completion of RT and was recorded according to RECIST, version 1.1.
Secondary outcomes (5)
- measure
- Treatment-emergent adverse events
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. age:18-75 years, male or femal. 2. Histologically or cytologically confirmed Squamous Cell Carcinoma of the Esophagus, locally advanced, unresectable disease. 3. Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. 4. Can provide either a newly obtained or archival tumor tissue sample. 5. ECOG 0-1. 6. Life expectancy of greater than 12 weeks. 7. Adequate organ function. 8. Female: child bearing potential, a negative urine or serum pregnancy test result within 72 h before study treatment. Participants of reproductive potential must be willing to use adequate contraception for the course of the study through 3 months after the last dose of SHR-1210. 9. Patient has given written informed consent. Exclusion Criteria: 1. Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy. 2. Complete obstruction of the esophagus, or patients who have the potential to develop perforation 3. Other malignancy within 5 years prior to entry into the study, expect for curatively treated basal cell and squamous cell carcinoma of the skin and/or curatively resected in-situ cervical and/or breast cancers. 4. Known central nervous system (CNS) metastases. 5. Subjects with any active autoimmune disease or history of autoimmune disease. 6. Uncontrolled clinically significant heart disease, including but not limited to the following: (1) \> NYHA II congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention; 7. Active infection or an unexplained fever \> 38.5°C during screening or before the first scheduled day of dosing (subjects with tumor fever may be enrolled at the discretion of the investigator); 8. History of Interstitial Pneumonia or active non-infectious pneumonitis. 9. Known Human Immunodeficiency Virus (HIV) infection、active Hepatitis B or Hepatitis C. 10. Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) agent. 11. Known history of hypersensitivity to macromolecular protein preparation or any components of the SHR-1210 formulation. 12. Concurrent medical condition requiring the use of cortisol (\>10mg/day Prednisone or equivalent dose) or other systematic immunosuppressive medications within 14 days before the study treament. Except: inhalation or topical corticosteroids. Doses \> 10 mg/day prednisone or equivalen for replacement therapy. 13. Has received prior anti-cancer monoclonal antibody (mAb), chemotherapy, targeted small molecule therapy, or radiation therapy within 4 weeks prior to study Day 1 or not recovered from adverse events due to a previously administered agent. 14. Received a live vaccine within 4 weeks of the first dose of study medication. 15. Pregnancy or breast feeding. 16. Decision of unsuitableness by principal investigator or physician-in-charge.
References
Publications (0)
Data not yet available
No reference posted for this study.