Active clinical trials for "Pancreatic Neoplasms"

This is a multicenter, prospective, observational study to evaluate the utility of the Invitae Personalized Cancer MonitoringTM assay for patients with resectable and unresectable pancreatic cancer. Using tumor tissue, a personalized blood test (the Invitae Personalized Cancer MonitoringTM test) will be developed that can be used for repeated monitoring to assess for the presence or absence of circulating tumor DNA (ctDNA). The presence of residual cancer cells after treatment is known as molecular residual disease (MRD) and the detection of ctDNA can provide evidence of the presence of MRD. Participants in this study will have their blood drawn at various time points throughout their cancer treatment to test for ctDNA and monitoring with the Invitae Personalized Cancer MonitoringTM test will continue until disease progression or the duration of the study.

This is a single-center, open-label randomized controlled Phase II clinical study to observe and evaluate the efficacy and safety of Sovantinib in combination with AG versus AG first-line treatment in patients with locally advanced or metastatic pancreatic cancer. According to the literature analysis, the mPFS of gemcitabine combined with albumin-binding paclitaxel in first-line treatment of metastatic pancreatic cancer was 3.56 months in historical controlled studies, and the expected PFS of soantinib combined with AG regimen increased from 2.06 months to 4.5 months after 2 cycles of AG regimen. Follow-up time was 12 months and enrollment time was 18 months. α=0.05 and β=0.2 were used for bilateral test, and the PASS 22 software was used for analysis. The sample size of AG group in the control group was 29 cases, and that of AG combined with Solvatinib in the experimental group was 29 cases. The total sample size needed to be enrolled was 58 cases, and a total of 65 subjects were required according to the 10% shedding rate. This study was divided into three stages: screening period, treatment period and follow-up period. During treatment, tumor status was assessed by imaging every 6 weeks (±7 days) until disease progression (PD, RECIST 1.1) or death (during patient treatment) or toxicity intolerance or other protocol criteria for discontinuation of study therapy were met. A maximum of 6 treatment cycles of AG chemotherapy were specified, and soantinib was continued until disease progression (PD, RECIST 1.1) or death (during patient treatment) or toxicity intolerance or other criteria for discontinuation of study therapy were met in the protocol. Tumor treatment and survival status after disease progression were recorded. Safety outcomes included AE, changes in laboratory test values, vital signs and electrocardiogram changes.

Advanced pancreatic cancer is a highly aggressive and fatal disease with an extremely low 5-year survival rate. Combined chemotherapy is the mainstay of treatment for patients with unresectable advanced pancreatic cancer, and the combination of nab-paclitaxel and gemcitabine (AG regimen) has been one of the most commonly used regimens for more than a decade. However, chemo-resistance often occurs within half a year and the efficacy remains unsatisfied with an overall survival of only 9~11 months. Immune checkpoint inhibitors (ICIs) such as anti-PD-1/L1 antibody and anti-CTLA-4 antibody have demonstrated encouraging anti-tumor efficacy in multiple solid tumors including lung cancer, gastric cancer, and esophageal cancer, while obtained controversial results when combined with chemotherapy in pancreatic cancer. Recently, the immune-suppression tumor microenvironment (TME) of pancreatic cancer has been described in several pre-clinical studies, which may explain the resistance against ICIs and chemotherapy. KN046 is a recombinant humanized PD-L1/CTLA-4 bispecific antibody with innovative designs include a proprietary CTLA-4 domain antibody with a significantly improved safety profile, a bispecific antibody fused with PD-L1 antibody targeting the TME with high PD-L1 expression. Recent clinical studies have shown promising anti-tumor activity of KN046 in pancreatic cancer. Surufatinib, also known as HMPL-012 or Sulfatinib, is a small molecular tyrosine kinase inhibitor (TKI) targeting the Vascular Endothelial Growth Factor Receptor (VEGFR), Fibroblast Growth Factor Receptor (FGFR) and Colony Stimulating Factor-1 Receptor (CSF-1R), which has a dual mechanism of action of anti-angiogenesis and regulation of immune microenvironment. Previous studies have suggested synergic effect of surufatinib in combination with anti-PD-1 antibodies. This phase Ib/II clinical trial is intended to investigate the activity and safety of the combination of surufatinib combined with KN046 and the AG regimen chemotherapy as first-line treatment in patients with unresectable locally advanced or metastatic pancreatic cancer.

This study is a multicenter, open-label, phase II study to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activities of AK104，a PD-1/CTLA-4 bispecific antibody, in combination with gemcitabine and nab-paclitaxel as first-line therapy in subjects with advanced unresectable or metastatic pancreatic ductal adenocarcinoma.

Compare open and laparoscopic assisted pancreaticoduodenectomy regarding intraoprative blood loss, organ injury, completion of planned laparoscopic steps, duration and early post operative course of pain, hem stability, oral feeding, leakage(pancreatic, billary and intestinal). ,bleeding, mortality, lymph nodes and safety margins .

Rationale: Adjuvant chemotherapy after surgery significantly improved the survival of PC patients, but there is a problem that only about 50% of patients start adjuvant chemotherapy after pancreatectomy. Neoadjuvant chemotherapy might control potential metastatic lesion which are not being detected in early diseases status and improve the R0 resection rate. In addition, it prevents futile surgery by selecting patients with rapid progression of disease. Furthermore, compared to chemotherapy administered after surgery, more patients can complete the planned chemotherapy schedule in neoadjuvant setting. Asians differ from Westerners not only in racial differences, but also in average size and body surface area. Accordingly, there is an urgent need for clinical studies on the dose, toxicity, dosing cycle, and efficacy of anticancer drugs that reflect actual clinical trials in Asian countries for Asians. There are still few studies worldwide that prospectively explored the efficacy of neoadjuvant chemotherapy in resectable PC and the administration of neoadjuvant therapy in resectable PC depends on individual clinical judgment. Therefore, systematic and prospective clinical trials are essential to standardize treatment protocol in resectable PC. Obective: To investigate whether 6 cycles of preoperative mFOLFIRINOX - surgery - 6 cycles of postoperative mFOLFIRINOX improves overall survival by intention-to-treat compared to surgery followed by 12 cycles of postoperative mFOLFIRINOX. Study design: open-label, multicenter, randomized, phase 3 clinical trial Study population: Patients with resectable pancreatic cancer and ECOG performance 0 or 1. Intervention: Invervention arm : 6 cycles of neoadjuvant mFOLFIRINOX followed by surgical resection and 6 cycles of adjuvant mFOLFIRINOX Comparator arm : surgical resection followed by 12 cycles of adjuvant mFOLFIRINOX Primary endpoint: 2-year overall survival rate by intention-to-treat

The overall study objective of this trial study is to identify and evaluate strategies to improve the accessibility of the video education with result dependent disclosure (VERDI) model, increasingly utilized as a pre-genetic testing (pretest) education alternative in clinical practice, to better serve a more diverse patient population at risk for hereditary cancers.

Pancreatic cancer (PC) is a deadly disease and surgical resection of the tumor is the only hope of cure. Approximately 20-25% of the PC patients are candidates for intended curative resection, but despite microscopically radical resection the majority of patients will have recurrent disease within 2 years. This indicates that most patients will harbour non-detected (i.e. occult) cancer cells at the time of resection. Studies suggest that free tumor cells in the peritoneum and in the blood are part of this occult disease burden, and that patients with such findings should not be operated but treated as having metastatic disease. However, the exact incidence of these tumor cells in an unselected cohort of patients undergoing pancreatic resection is unknown, and the potential impact on postoperative survival is also uncertain. In recent years, molecular biomarkers are increasingly being regarded as both predictive and prognostic tools for cancer patients. This study will use the most optimal available methods to investigate the incidence of biomarkers for tumor cells in the peritoneum and blood in PC patients, and to relate these findings to the final outcome of the resected patients. This project has become highly relevant since new treatment methods (i.e. Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC)) may be used to eradicate free tumor cells. A recent systematic review and meta-analysis demonstrated that PC patients with positive peritoneal cytology (Cy+) had a significant poorer survival than patients with negative peritoneal cytology (Cy-) (HR 3.18), and the authors concluded that Cy+ patients should not undergo surgery. This conclusion was supported by a significant lower overall survival and a higher peritoneal recurrence rate after resection of Cy+ patients when compared to Cy- patients. Agreement that Cy+ in resectable PDAC is a negative predictor of prognosis came from another recent meta-analysis and systematic review. However, this study also indicated that the median OS was worse in patients without than in those with resection among patients with Cy+, thereby emphasizing need of further careful assessment of indications for radical resection in Cy+ patients. KRAS mutations have been detected in circulating tumor DNA (ctDNA) in the blood (liquid biopsies) from patients with metastatic PC, and ctDNA is considered a marker of poor prognosis. Similar, KRAS mutations were found in the plasma of one-third of patients with a resectable tumor, and ctDNA positive (ctDNA+) patients had a significantly poorer overall survival (13.6 months vs 27.6 months, p<0.0001). Similar conclusions were drawn in recent systematic reviews and meta-analyses, while one study failed to confirm these results. The detection of KRAS mutations in cell-free DNA has also been identified as a prognostic biomarker in PC patients. If looking at studies including all stages of PC patients, the prevalence of KRAS mutations in liquid biopsies was 40.8%, and these mutations had a negative impact on overall survival with a HR of 3.16. Different ctDNA detection methods have been used, however the recent introduction of digital droplet PCR (ddPCR), a new robust PCR method for quantifying low-abundance point mutations in cell-free circulating DNA, shows promising results and offers increased sensitivity and reproducibility relative to quantitative PCR (qPCR). The treatment of resectable, locally advanced and metastatic PC has changed significantly over the past few years. New chemotherapy regimens have improved survival in metastatic PC, and these regimens (+/- radiation therapy) are presently being tested in both resectable and locally advanced PC with promising preliminary results. In theory, these new regimens may be potentially effective against ctDNA in PC patients, whereas the effect on peritoneal lavage positive (PLF+) PC patients is more speculative due to the low intraperitoneal concentrations of systemic chemotherapy. However, the latter problem may be solved by using Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) which allows better intraperitoneal distribution, concentration and accumulation of chemotherapy, without the systemic side effects. It may be speculated that the highly sensitive ddPCR of KRAS may be a better tool for PLF+ detection when focusing on PC patients, as up to 95% of these harbour mutations in this gene. So far, only very few studies used PCR to evaluate KRAS mutations in PLF in PC patients. Main study aims are: We aim to investigate the incidence of PLF+ and KRAS ctDNA in the blood from an unselected cohort of PC patients scheduled for attempted curative surgery. Secondly, we will study the prognostic impact of PLF+ and KRAS ctDNA positivity in PC patients.

The Marathon of Hope Cancer Centres Network (MOHCCN) is a national network of cancer centres that pursue collaborative cancer research in precision medicine (an emerging approach for disease treatment and prevention that considers individual variability in DNA, environment and lifestyle) to accelerate the discovery of innovations and improve the health outcomes for cancer patients

No validated biomarkers to identify PC at an early stage and to predict treatment outcomes in the individual patient exist. The objective of the present study is to find diagnostic, prognostic and predictive biomarkers.