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This study aims to explore the efficacy and safety of intra- arterial infusion of gemcitabine and oxaliplatin in locally advanced pancreatic cancer. This protocol is overseen by the Fudan University Institutional Review Board which has Federal Wide Assurance through the U.S. Department of Health & Human Services (Approved: April 25, 2002).
Primary Outcome Measures:
To compare the overall survival (OS) in patients with locally advanced pancreatic cancer treated with transcatheter arterial infusion (TAI) of chemotherapeutics or systemic delivered chemotherapy.
Secondary Outcome Measures:
To compare the progression free survival (PFS), objective response rate (ORR), quality of life (QoL), and adverse effects of treating locally advanced pancreatic cancer patients with TAI or systemic chemotherapy.
Exploratory Outcome Measures:
To evaluate the correlation between prognosis and expression of serum microRNAs of the patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAI chemotherapy | Experimental | Patients in this arm will receive transcatheter arterial infusion of chemotherapy with gemcitabine and oxaliplatin every 2 weeks, until progression of disease or adverse effects leading to treatment termination. Each 4-week period is one cycle of treatment. |
|
| Chemotherapy | Active Comparator | Patients in this arm will receive intravenous chemotherapy with gemcitabine and oxaliplatin every 2 weeks, until progression of disease or adverse effects leading to treatment termination. Each 4-week period is one cycle of treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcatheter arterial infusion | Procedure |
| ||
| Intravenous chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | From date of randomization until the date of death, assessed up to 100 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months. |
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Inclusion Criteria:
Granulocytes ≥ 1,500/uL Hemoglobin ≥ 8.0 gm/dL Platelets ≥ 100,000/uL Serum creatinine < 2.0 mg/dL Bilirubin < 1.5 mg/dL SGPT < 2.5 x normal Alk Phos < 2.5 x normal
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yehua Shen, MD, Ph D | Contact | 86-21-64175590 | 83625 | yehuash25@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhiqiang Meng, MD, Ph D | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39095759 | Derived | Huang C, Cheng CS, Shen Y, Chen H, Lin J, Hua Y, Feng L, Wu C, Wang P, Chen Z, Meng Z. Digital subtraction angiography-guided pancreatic arterial infusion of GEMOX chemotherapy in advanced pancreatic adenocarcinoma: a phase II, open-label, randomized controlled trial comparing with intravenous chemotherapy. BMC Cancer. 2024 Aug 2;24(1):941. doi: 10.1186/s12885-024-12695-8. |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Procedure |
|
| Gemcitabine | Drug |
|
| Oxaliplatin | Drug |
|
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |