Effect of Drug Clinical Trial
Official title:
Treatment With Nivolumab and All-trans Retinoic Acid for Patients With Refractory Pancreatic Cancer
This study is to examine the anticancer activity of the combination therapy with all-trans retinoic acid and nivolumab in patients with chemotherapy-refractory advanced or metastatic pancreatic adenocarcinoma.
Pancreatic cancer is an aggressive and lethal disease. Even two combination regimens, FOLFIRINOX and albumin-bound paclitaxel in combination with gemcitabine, are superior to gemcitabine alone as the first-line treatments, the prognosis of patients with locally advanced or metastatic pancreatic cancer remains poor, with a median overall survival of 8 to 11 months and an estimated 2-year survival of only 2%. Even more, there is currently no available treatment proven beneficial for patients who fail the second-line therapy with liposomal irinotecan in combination with 5-FU. Immune checkpoint inhibitors targeting PD-1 or PD-L1 represent a popular treatment option for patients with some kinds of cancers, but previous studies in pancreatic cancer have failed. One critical challenge for immunotherapy in pancreatic cancer is to find efficient therapeutic approaches to reverse this "cold" tumor into a "hot" tumor. Our previous basic studies revealed that all-trans retinoic acid repressed pancreatic adenocarcinoma cell growth and colony formation. Set-to-set genetic analysis revealed that genes regulated by all-trans retinoic acid were predominantly involved in immune response including interleukin-6, tumor necrotic factor-α, IFNs signaling, and PD-L1. Furthermore, mice bearing pancreatic cancer treated with combination of anti-PD-1 and all-trans retinoic acid had a significantly longer survival compared to mice treated with anti-PD-1 or all-trans retinoic acid alone. Based on the previous findings, we propose this pilot, compassionate use of combination therapy with all-trans retinoic acid and nivolumab for patients with locally advanced or metastatic pancreatic adenocarcinoma who are refractory to current available treatment. This study will also examine ADAR1 as a novel prognostic and predictive biomarker for pancreatic adenocarcinoma patients. This study will help to delineate the role of ADAR1 as a predictive biomarker for immunotherapy, all-trans retinoic acid as a suppressor of ADAR1, and most importantly, the combination of all-trans retinoic acid and nivolumab as an effective anticancer therapy for patients with pancreatic adenocarcinoma. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT04549012 -
Determination of Blood Loss After CS
|
Early Phase 1 | |
| Active, not recruiting |
NCT06114758 -
Comparison Effectiveness of Rectal Misoprostol & Intravenous Tranexamic Acid Reducing Hemorrhage in Myomectomy
|
||
| Completed |
NCT05076253 -
Efficacy of Ivermectin in COVID-19
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04573049 -
The Effectiveness and Safety of Levosimendan in Patients With Severe Aortic Stenosis and Heart Failure Undergoing Transcatheter Aortic Valve Replacement
|
Phase 4 | |
| Not yet recruiting |
NCT04562493 -
Comparative Effect of Transforaminal Injection of Magnesium Sulphate Versus Ozone Therapy on Oxidative Stress Biomarkers in Lumbar Disc Related Radicular Pain
|
N/A | |
| Completed |
NCT04762147 -
Comparison of Perioperative Analgesia Between Intravenous Paracetamol and Fentanyl for Rigid Hysteroscopy
|
Phase 3 | |
| Completed |
NCT06432309 -
Opicapone as Adjunctive Therapy to Levodopa-Carbidopa Intestinal Gel in Parkinson's Disease
|
N/A | |
| Not yet recruiting |
NCT05510986 -
The Effect of Oxycodone Hydrochloride on CRBD After TURBT Under General Anesthesia
|
N/A | |
| Recruiting |
NCT05968885 -
Evaluation the Efficacy Between Botox Injection and Combination Pharmacotherapy in Patients With Detrusor Overactivity
|
Phase 4 | |
| Recruiting |
NCT05092074 -
Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) for Patients With Hepatitis C Virus Infection
|
||
| Recruiting |
NCT05595044 -
Effect of Vitamin D Therapy in Autism Spectrum Disorder
|
Phase 1 | |
| Not yet recruiting |
NCT06100510 -
PFA 100 Evaluation and Reference Interval HOACNY
|
Phase 4 | |
| Completed |
NCT05060913 -
Emla Cream Versus Benzocaine on Analgesia
|
Early Phase 1 | |
| Not yet recruiting |
NCT05293119 -
Role of Tofacitinib in Vitiligo Patients
|
Early Phase 1 | |
| Not yet recruiting |
NCT06414018 -
Effect of Equivalent Dose Sufentanil and Afentanil in Bronchoscopic Treatment
|
N/A | |
| Recruiting |
NCT05786859 -
The Efficacy and Safety of Rifaximin Treatment
|
Early Phase 1 | |
| Not yet recruiting |
NCT06290219 -
The Effect of Platelet-rich Plasma Nasal Injection in the Treatment of Traumatic Olfactory Dysfunction
|
Phase 3 | |
| Completed |
NCT05277480 -
Apatinib With Ifosfamide Plus Etoposide for Relapsed or Refractory Osteosarcoma (OAIE)
|
Phase 2 | |
| Not yet recruiting |
NCT04892212 -
Sirolimus in Treatment of Proteinuric Flares of Lupus Nephritis
|
Phase 2/Phase 3 | |
| Not yet recruiting |
NCT05918146 -
Dextrose Therapy on Physical Therapy in Subdeltoid Bursitis
|
Phase 4 |