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 study is a prospective, single-arm trial, aiming to enroll 30 patients with unresectable locally advanced or oligometastatic pancreatic cancer. The study will evaluate the efficacy and safety of nintedanib combined with radiotherapy and chemotherapy (gemcitabine or capecitabine monotherapy). The primary endpoint of this study is the 1-year local control rate (LCR).
1. Radiotherapy: Conventional fractionated radiotherapy or SBRT can be selected.
2. Nintuzumab: Nintuzumab 400mg, intravenous infusion, on day 1, administered once a week (QW). Mix400 mg of nintuzumab injection with 250ml of sodium chloride solution, and the infusion time should be more than 60 minutes. Administer concurrently during radiotherapy and discontinue use after radiotherapy.
3. Chemotherapy (either tegafur or capecitabine, choose one):
Continue the treatment until the disease progresses or an intolerable toxic reaction occurs.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nimotuzumab + chemoradiotherapy group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nimotuzumab combined with chemoradiotherapy | Drug | The patient received treatment with nimotuzumab combined with radiotherapy and chemotherapy. The radiotherapy could be conducted using conventional fractionated radiotherapy or SBRT, and the chemotherapy could be carried out using tegafur or capecitabine. |
| Measure | Description | Time Frame |
|---|---|---|
| LCR | Local Control Rate | The 1-year local control rate (LCR) of patients receiving nivolumab combined with radiotherapy and chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| OS | overall survival | The survival rates for 1 year, 2 years, and 5 years |
| PFS | Progression-free survival | Every 3 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Radiotherapy Oncology, Peking University First Hospital | Beijing | Beijing Municipality | 100034 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| ID | Term |
|---|---|
| D059248 | Chemoradiotherapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
Not provided
Not provided