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This phase II study is to evaluate the safety and efficacy of CT-based adaptive radiation therapy followed by adjuvant anti-PD-1 antibody immunotherapy in treating patients with different types and stages of thoracic malignancies. (CARTAI)
PRIMARY OBJECTIVES:
I. To evaluate the safety and toxicity of anti-programmed cell death 1 (PD-1) inhibition consolidation therapy after radiation therapy for multiple thoracic malignancies.
SECONDARY OBJECTIVES:
I. To assess the efficacy of adjuvant anti-PD-1 antibody immunotherapy after radiotherapy.
II. To understand the dynamics and interactions of IDO with others immune pathway biomarkers.
III. To evaluate whether IDO immune status could predict the treatment outcomes of radiation and immune combined therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anti-PD-1 antibody | Experimental | IBI308 200mg intravenous drip every three weeks following adaptive radiation therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI308 | Drug | A humanized anti-PD-1 monoclonal antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| AEs and SAEs at 6 months | Number of participants with adverse events and serious adverse events at 6 months will be measured. [CTCAE v4.03] | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective response rate is the percentage of patients with at least once occurrence of PR or CR [RECIST v1.1] | Estimated to be up to 3 years |
| DoR | Duration of response is the time interval from first occurrence of PR or CR until PD or death [RECIST v1.1] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haihua Yang, MD | Contact | +86 13819639006 | yhh93181@hotmail.com | |
| Yinnan Meng, MD | Contact | +86 13486208109 | mengyn6484@enzemed.com |
| Name | Affiliation | Role |
|---|---|---|
| Fengming (Spring) Kong, MD | Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University | Principal Investigator |
| Haihua Yang, MD | Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taizhou Hospital of Zhejiang Province | Recruiting | Taizhou | Zhejiang | 317000 | China |
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| ID | Term |
|---|---|
| C000632826 | sintilimab |
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| Estimated to be up to 3 years |
| AEs | Number of patients with acute and chronic adverse events will be measured [CTCAE v4.03] | Estimated to be up to 3 years |
| PFS | Progression-Free-Survival is the time interval from the start of treatment until disease progression or death by any cause [RECIST v1.1] | Estimated to be up to 3 years |
| OS | Overall Survival is the time interval from the start of treatment to death from any cause. | Estimated to be up to 3 years |
| Yinnan Meng, MD | Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University | Principal Investigator |