Clinical Research Directory

Phase I Nab-Paclitaxel Plus Gemcitabine With Proton Therapy for Locally Advanced Pancreatic Cancer (LAPC)

The purpose of this study is to determine the maximum tolerated dose of the chemotherapy drugs nab-paclitaxel and gemcitabine when combined with hypofractionated ablative proton therapy for the treatment of locally advanced pancreatic cancer. You will receive proton therapy once a day (Monday - Friday) for 3 weeks. Participants will also receive chemotherapy on each Monday of those three weeks.

Endoscopic Ultrasound-Guided Loco-regional Chemotherapy Injection as Adjuvant Therapy for Locally Advanced Pancreatic Cancer.

this is a randomized controlled trial aims to compare between patients with locally advanced pancreatic cancer treated with EUS-guided injection of gemcitabine in addition to systemic chemotherapy, versus those who treated with the standard systemic chemotherapy alone, regarding to(progression -free survival and response rate). Researchers will compare Arm A: patients received EUS-FNI of gemcitabine plus standard systemic chemotherapy to Arm B : patients receiving the standard systemic chemotherapy alone.

Combined Chemotherapy And Ablative Radiotherapy (SBRT) As First-Line Treatment In Locally Advanced Inoperable Pancreatic Cancer (SBRT-PANC)

This prospective interventional clinical study evaluates the efficacy and safety of combining systemic chemotherapy followed by ablative stereotactic body radiotherapy (SBRT) as first-line treatment in adult patients with locally advanced, inoperable pancreatic cancer. The study aims to determine the response rate after SBRT delivered following initial chemotherapy, as well as time to disease progression and treatment-related toxicity. Patients receive standard first-line chemotherapy and, in the absence of disease progression, undergo ablative SBRT to the primary tumor, followed by continuation of systemic therapy according to clinical practice. The study is conducted in Slovenia, with patient enrollment expanded to additional participating clinical centers following an approved amendment.

FOLFIRINOX Versus OncoSil™ in Addition to FOLFIRINOX in Patients With Locally Advanced Pancreatic Adenocarcinoma

The purpose of the study is to assess the safety and efficacy of OncoSil™ when given in addition to standard FOLFIRINOX chemotherapy for treatment of Locally Advanced Pancreatic Cancer

Chemotherapy With or Without IMD10 (Focused Ultrasound) in the Treatment of Borderline Resectable or Locally Advanced Pancreatic Cancer

The purpose of this Interventional clinical trial is to evaluate safety and efficacy of 'IMD10 (focused ultrasound)' in the treatment of borderline resectable pancreatic cancer or locally advanced pancreatic cancer.

Alpha Radiation Emitters Device (DaRT) for the Treatment of Locally Advanced Pancreatic Cancer

A unique approach for cancer treatment including radioactive sources named Alpha DaRT sources: Ra - 224 coated onto stainless steel tubes inserted into the tumor for the treatment of Locally Advanced Pancreatic Cancer .

Intra-arterial Gemcitabine vs. IV Gemcitabine and Nab-Paclitaxel Following Radiotherapy for LAPC

The study is a multi-center, open-label, randomized active controlled study of subjects with locally advanced pancreatic adenocarcinoma which is unresectable.

MicroEnvironment Tumor Effects of Radiotherapy - Comprehensive Radiobiology Assessment TRial

This study is a dynamically adjustable prospective longitudinal study designed to capture biospecimen (biopsy, blood, surgical) and multimodal treatment-related data (imaging, dosimetry, clinical) before, during, and after treatment with definitive-intent chemoradiotherapy for patients with locally advanced cervical and pancreatic cancer.

Stereotactic Centralized Ablative Radiotherapy for Locally Advanced Pancreatic Cancer: A Single-Arm Phase I Safety and Feasibility Study

This is a single-arm, phase I clinical study designed to evaluate the safety and feasibility of SCART (Stereotactic Centralized Ablative Radiation Therapy) dose escalation in patients with locally advanced pancreatic cancer. Pancreatic cancer carries a dismal prognosis, and the majority of patients are not surgical candidates at diagnosis. Radiotherapy is an important local treatment modality, but conventional approaches have shown limited efficacy. SCART is intended to deliver higher ablative doses to the tumor core while minimizing toxicity to surrounding normal tissues. In this trial, eligible patients will receive SCART with escalating dose levels using a standard 3+3 design. The primary endpoints are to determine the dose-limiting toxicity (DLT) and the maximum tolerated dose (MTD). Secondary endpoints include overall survival (OS), local control rate (LCR), and objective response rate (ORR).

Ceralasertib (AZD6738) Alone and in Combination With Olaparib or Durvalumab in Patients With Solid Tumors

This phase II trial studies how well ceralasertib, am Ataxia telangiectasia and Rad3-related (ATR) kinase inhibitor, works alone or in combination with olaparib or durvalumab in treating participants with renal cell carcinoma (RCC), urothelial carcinoma, all pancreatic cancers, endometrial cancer, and other solid tumors excluding clear cell ovarian cancer that have spread to nearby tissue or lymph nodes or other parts of the body. ATR kinase inhibitor AZD6738 and olaparib or durvalumab may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not known if giving ATR kinase inhibitor AZD6738 with or without olaparib or durvalumab may work better in treating participants with solid tumors.

Systemic Therapy With a Loco-regional Treatment in Patients With Locally Advanced Pancreatic Cancer

Background Pancreatic cancer is one the leading causes of cancer-related death in Canada. Approximately 40 percent of patients with pancreatic cancer present with locally advanced pancreatic cancer and are not candidate for curative surgery. The optimal management of patients with locally advanced pancreatic cancer remains unknown. Most patients are treated with chemotherapy alone and role of local treatment such as radiation is not well defined. Other conventional ablative therapies such as thermal ablation and cryoablation have limited role in locally advanced pancreatic cancer due to the risk of collateral damage to the adjacent structures. Irreversible electroporation (IRE) is a novel non-thermal ablation technology that does not cause injury to nearby blood vessels, ducts, and bowel and has potential to provide longer disease control and thereby a better overall survival. The current study aims to prospectively validate effectiveness and safety of IRE in real-world patients with locally advanced pancreatic cancer. Objectives 1\) To determine 12-month progression-free survival (PFS) and 24-month overall survival rates of patients with locally advanced pancreatic cancer who are treated with combination chemotherapy and IRE and 2) to compare progression-free and overall survival of patients with locally advanced pancreatic cancer who are treated with combination chemotherapy and IRE versus combination chemotherapy alone. Design Prospective multicenter single arm study. Methods Based on the assumption of doubling of PFS of patients who are being treated with IRE and chemotherapy versus chemotherapy alone we estimated a sample of n=27 of adult patients with histologically proven non-metastatic locally advanced adenocarcinomas. Eligible patients will be recruited at the two major cancer centers in Saskatchewan. All IRE eligible patients will receive 12 weeks of induction chemotherapy and will undergo repeat imaging studies. If there is no disease progression IRE will be performed. An additional 12 weeks of chemotherapy will be recommended. Patients who are not eligible for IRE due to size criteria will receive chemotherapy at the discretion of treating oncologist till disease progression or till they become eligible for IRE. Quality of life will be assessed every three months or until disease progression. Significance Despite progress in the management of most solid organ cancers and better outcomes, little advancement has been made in the treatment of patients with locally advanced pancreatic cancer. Unfortunately, most patients have very limited life expectancy. There is an unmet need for novel approaches in the management of patients with locally advanced pancreatic cancer. IRE in combination with chemotherapy has potential to improve local disease control and thereby improves survival and may prove a valuable tool to add in the multidisciplinary treatment of cancer. The result of this study will be used for the development of a future multicenter national phase III trials.

A New Clinical Pathway for Personalized Management of Borderline Resectable and Locally Advanced Pancreatic Cancer

NORPACT-3 is a nationwide, Norwegian single arm prospective study that evaluates the resectability rates and survival in patients with borderline resectable and locally advanced pancreatic cancer who received primary chemotherapy. Eligible patients are treated with primary chemotherapy possibly followed by surgical exploration and resection. All Norwegian centres performing pancreatic surgery have agreed to collaborate in this trial. The assignment of the medical intervention is not at the discretion of the investigator, but follow the national Norwegian guidelines regarding diagnostic work up, oncological and surgical treatment and follow up. The primary aim is a national resection rate of 50% in BRPC and 15% in LAPC in patients initiating primary chemotherapy, with adequate overall survival and morbidity/mortality (after resection median overall survival of 24 months, 1 year survival 80%, and 5 year survival \>20% + 90 day postoperative mortality ≤5%, 90-day postoperative major morbidity (Clavien Dindo grade 3) ≤40%).

Clinical Study of Tumor Treating Fields Combined with Gemcitabine and Albumin-bound Paclitaxel in the First-line Treatment of Locally Advanced Pancreatic Cancer

The Objectives of this clinical trial is to evaluate the efficacy and safety of tumor treating fields combined with gemcitabine and albumin bound paclitaxel in the treatment of locally advanced pancreatic cancer.

mFOLFIRINOX Plus Anlotinib and Sintilimab for Advanced Pancreatic Cancer

This study is a prospective, single-arm, multicenter, phase Ib/II clinical trial that treats previously untreated patients with locally advanced or metastatic pancreatic cancer using mFOLFIRINOX in combination with anlotinib and sintilimab. The purpose of this trial is to evaluate the efficacy and safety of this treatment regimen and to preliminarily explore the correlation between biomarkers and treatment outcomes.

NALIRIFOX Combined With PD-1 Sequential Radiotherapy Versus NALIRIFOX as Conversion Therapy of Locally Advanced Pancreatic Cancer

The purpose of the prospective, open, randomized controlled, multicenter, exploratory clinical study is to evaluate efficacy and safety of NALIRIFOX Combined With PD-1 Sequential Radiotherapy Versus NALIRIFOX for Conversion Therapy for Locally Advanced Pancreatic Cancer

NALIRIFOX Combined With PD-1 Sequential Radiotherapy Versus AG Combined With PD-1 Sequential Radiotherapy as First-line Treatment of Locally Advanced Pancreatic Cancer

The purpose of the study is to evaluate the efficacy and safety of NALIRINOX combined with PD-1 synchronous sequential SBRT or AG combined with PD-1 synchronous sequential SBRT as first line systematical therapy in patients with ocally advanced pancreatic cancer.

Nimotuzumab Plus NALIRIFOX in Locally Advanced Pancreatic Cancer

This is a prospective, open-label, single arm clinical study. The main purpose of the study is to evaluate the clinical efficacy and safety of Nimotuzumab combined with NALIRIFOX in the treatment of locally advanced pancreatic cancer (LAPC).

Surufatinib and Serplulimab Combined With AG Regimen Compare With AG Regimen as Conversion Therapy for Patients With Locally Advanced Pancreatic Cancer (SAGE)

This is a Phase II Randomized Controlled PILOT clinical study. The purpose of this study is to explore the efficacy and safety of surufatinib and serplulimab in combination with albumin-paclitaxel and gemcitabine in the conversion therapy for patients with unresectable locally advanced pancreatic cancer. Furthermore, it compares the efficacy of surufatinib and serplulimab in combination with albumin-paclitaxel and gemcitabine to the albumin-paclitaxel and gemcitabine regimen in the conversion therapy for patients with unresectable locally advanced pancreatic cancer.

SBRT Combined With Zimberelimab (GLS-010) in Locally Advanced Pancreatic Cancer (SPARK-1 Study)

This trial is designed to investigate the efficacy and safety of patients with locally advanced pancreatic cancer by SBRT combined with Zimberelimab(GLS-010).