Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This trial is designed to investigate the efficacy and safety of patients with locally advanced pancreatic cancer by SBRT combined with Zimberelimab(GLS-010).
This a prospective, single-arm, multicenter study evaluating the efficacy and safety of stereotactic radiotherapy (SBRT) and Zimberelimab(GLS-010) in patients with pancreatic cancer. The primary endpoint is OS, and the secondary are PFS, ORR,DCR and adverse events.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SBRT Combined With Zimberelimab | Experimental | Patients diagnosed with locally advanced pancreatic cancer are treated with SBRT combined with Zimberelimab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic body radiation(SBRT) | Radiation | SBRT: 7-10 Gy/F, 5 doses Zimberelimab: 240mg d1 iv Q21D, within 7 days after SBRT completion. Receiving a minimum of six cycles of treatment, or disease progression or intolerable toxic side effects. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | Overall survival (PFS) will be defined as the elapsed time from the first date of study treatment until death from any cause. For patients who remain alive, follow-up time will be censored at the date of last disease assessment. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | Progression-free survival (PFS) will be defined as the elapsed time from the first date of study treatment until documented disease progression (as per RECIST 1.1) or death from any cause, whichever is earlier. For patients who remain alive without progression, follow-up time will be censored at the date of last disease assessment. | 2 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junjie Wang, M.D. | Contact | +8613701076310 | wangjunjie_puth@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Junjie Wang, M.D. | Peking University Third Hospital | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| C000719848 | zimberelimab |
| D007167 | Immunotherapy |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Zimberelimab (GLS-010) | Drug | Zimberelimab (GLS-010),240mg d1 iv Q21D |
|
|
| Objective response rate (ORR) | Disease control rate will be defined as PR +CR rate. | 2 years |
| Disease Control Rate (DCR) | Disease control rate will be defined as objective response rate + steady disease rate. | 2 years |
| Adverse Events | Based on NCI-CTC AE v5.0 | 2 years |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |