scholarly journals First-line eradication rates comparing two shortened non-bismuth quadruple regimens againstHelicobacter pylori: an open-label, randomized, multicentre clinical trial

2015 ◽  
Vol 70 (8) ◽  
pp. 2376-2381 ◽  
Author(s):  
Antonio Cuadrado-Lavín ◽  
J. Ramón Salcines-Caviedes ◽  
Ainhoa Diaz-Perez ◽  
Miguel F. Carrascosa ◽  
María Ochagavía ◽  
...  
Keyword(s):  
Clinical Trial ◽  
First Line ◽  
Open Label ◽  
Multicentre Clinical Trial

scholarly journals Oral Nutritional Supplementation for the Dietary Management of Malnutrition in Cancer: Study Protocol of A Randomized, Open-Label, Multicentre Clinical Trial

2019 ◽  
Vol 4 (07) ◽  
Author(s):  
Edit Nadasi ◽  
Gellert Cseh
Keyword(s):  
Clinical Trial ◽  
Cancer Patients ◽  
Study Protocol ◽  
Negative Energy ◽  
Malignant Diseases ◽  
Open Label ◽  
Multicentre Clinical Trial ◽  
Patients With Cancer ◽  
Extra Energy ◽  
Oral Nutritional Supplements

In cancer, more than 30% of patients die due to cachexia and more than 50% of patients with cancer die with cachexia being present. Patients with cancer cachexia frequently develop a chronic negative energy and protein balance driven by a combination of reduced food intake and metabolic change. Several studies have already demonstrated the usefulness of oral nutritional supplements (ONS) in managing malnutrition of cancer patients. Though increased energy intake is very important in managing cancer-related malnutrition, the source of this extra energy and the presence of anti-inflammatory and immunonutritional components may also play an important role. Here we present the study protocol of a randomized, open-label, multicentre clinical trial aimed to determine whether an ONS composed according to the needs of patients with malignant diseases an ONS composed according to the needs of patients with malignant diseases is more effective than a general product in improving the nutritional status in cancer patients.

Update results from ALTER-C-001: Efficacy and safety of anlotinib plus XELOX regimen as first-line treatment followed by maintenance monotherapy of anlotinib for patients with mCRC-A single-arm, multicenter, phase Ⅱ clinical trial.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e15550-e15550
Author(s):  
Jin Yan ◽  
Yunwei Han ◽  
Li Zhang ◽  
Yongdong Jin ◽  
Hao Sun
Keyword(s):  
Clinical Trial ◽  
Adverse Events ◽  
Performance Status ◽  
Phase Iii ◽  
Line Treatment ◽  
First Line ◽  
Open Label ◽  
Ecog Performance Status ◽  
Multicenter Phase ◽  
First Line Treatment

e15550 Background: The combination of anti-VEGF or anti-EGFR targeted drugs with chemotherapy is the standard first-line therapy for metastatic colorectal cancer (mCRC), and the followed maintenance treatment is an optional approach to balance the efficacy and toxicity. However, studies regarding the maintenance strategies based on antiangiogenic TKIs are limited currently. Anlotinib, a novel oral multi-target TKI which can inhibit both tumor angiogenesis and tumor cell proliferation simultaneously, substantially prolonged the PFS with manageable toxicity for refractory mCRC in the phase III ALTER0703 clinical trial. Here we report an update on the effectiveness and safety of anlotinib plus XELOX as first-line treatment followed by anlotinib monotherapy for mCRC. Methods: In this open label, single-arm, multicenter phase II clinical trial, 53 mCRC patients without prior systemic treated, aged 18-75 and an ECOG performance status of 0 or 1 were planned to recruit. Eligible patients received capecitabine (1000 mg/m2, po, d1-14, q3w) and oxaliplatin (130 mg/m2, iv, d1, q3w) plus anlotinib (10mg, po, d1̃14, q3w) treatment for 6 cycles. After 6 cycles of inducing therapy, patients would receive anlotinib (12mg, po, d1̃14, q3w) as maintenance therapy until disease progression or intolerable adverse events (AEs). The primary endpoint was PFS; Secondary endpoints included ORR, DCR, DOR and safety. Results: By the data analysis cutoff date of January 22, 2021, a total of 18 patients were enrolled, of which 12 patients were available for efficacy assessment. In best overall response assessment, there were 50.0% PR (6/12), 33.3% SD (4/12) and 16.7% PD (2/12). The ORR was 50.0% (95% CI, 21.1-78.9%) and DCR was 83.3% (95% CI, 51.5-97.9%). The longest duration of treatment was 8.8 months and the response was still ongoing. The median PFS was not reached. The most common treatment related adverse events (TRAEs) of any grade (≥20%) were leukopenia, hypertension, neutropenia, diarrhea, fatigue, hypertriglyceridemia. Grade 3/4 TRAEs included hypertension (22.2%), hypertriglyceridemia (11.1%), lipase elevated (11.1%) and neutropenia (5.6%). No grade 5 AEs occurred. Conclusions: The update results suggested that anlotinib combined with XELOX as first line regimen followed by anlotinib monotherapy showed promising anti-tumor activity and manageable safety for patients with mCRC. And the conclusions needed to be confirmed in trials continued subsequently. Clinical trial information: ChiCTR1900028417.

Oral Nutritional Supplementation for the Dietary Management of Malnutrition in Chronic Pulmonary Diseases: Study Protocol of a Randomized, Open-label, Multicentre Clinical Trial

2018 ◽  
Vol 4 (2) ◽  
pp. 262-266
Author(s):  
Edit Nadasi ◽  
Gellert Cseh
Keyword(s):  
Clinical Trial ◽  
Study Protocol ◽  
Nutritional Supplements ◽  
Pulmonary Diseases ◽  
Dietary Management ◽  
Open Label ◽  
Multicentre Clinical Trial ◽  
Pulmonary Functions ◽  
Oral Nutritional Supplements ◽  
Chronic Pulmonary Diseases

Disease-related malnutrition is frequent in patients with chronic pulmonary diseases. Though there is no doubt about the usefulness of Oral Nutritional Supplements (ONS) in managing malnutrition in such patients, only a handful of publications are available in the literature on clinical trials with ONS in this patient population. Since the digestion of macronutrients results in a strain on the respiratory functions in severe pulmonary diseases, the source of energy may also play a crucial role in the efficacy of nutrition with ONS in such patients. Here we present the study protocol of a randomized, open-label, multicentre clinical trial aimed to determine whether a new, condition-specific ONS (with a composition tailored to the needs of patients with decreased pulmonary functions) is more effective compared to a general ONS in improving the nutritional status in patients with compromised respiratory functions.

PLATFORM: Planning treatment of oesophago-gastric (OG) cancer—A randomised maintenance therapy trial.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. TPS187-TPS187 ◽  
Author(s):  
Catherine Cafferkey ◽  
Ian Chau ◽  
Fiona Thistlethwaite ◽  
Russell D. Petty ◽  
Naureen Starling ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Overall Survival ◽  
Maintenance Therapy ◽  
Survival Benefit ◽  
Objective Response ◽  
Locally Advanced ◽  
First Line ◽  
Her2 Positive ◽  
Open Label ◽  
Line Chemotherapy

TPS187 Background: Outcomes for patients with advanced OG cancer remain poor, median overall survival for fit patients treated with platinum and fluoropyrimidine based chemotherapy is less than one year, with second line chemotherapy resulting in a modest (approximately 6 weeks) survival benefit for selected patients. Evidence from NSCLC trials suggests a survival benefit from maintenance treatment following first line chemotherapy. Emerging data also supports the use of immunotherapy in previously treated OG cancer. The PLATFORM study aims to evaluate maintenance therapy in patients with advanced OG cancer. Methods: This is a prospective, open label, multicentre, randomised phase II clinical trial which will recruit at multiple UK cancer centres. Eligible patients are those who have measurable stable disease or better following completion of first line chemotherapy (at least 6 cycles) for locally advanced unresectable or metastatic disease. First line chemotherapy regime should contain a platinum and 5-fluoropyridimine (with trastuzumab if HER2 +), doublet or triplet drug combinations are permitted. Maintenance strategies are split by HER 2 status. For HER2 negative patients these are: Arm A1: surveillance, Arm A2: capecitabine, Arm A3: MEDI 4736 (anti PDL1 inhibitor) and for HER2 positive patients; Arm B1: trastuzumab, Arm B2: in development. Target recruitment is six hundred and sixteen patients, 154 patients will be recruited to each arm, with an interim analysis following recruitment of 61 patients to each arm. An adaptive trial design enables ineffective treatments to be discontinued early, with the opportunity to add novel treatment arms as the trial progresses. Primary endpoint is progression free survival. Secondary endpoints are progression free rate at 3, 6 & 12 months, overall survival, objective response rate by RECIST 1.1, toxicity and analysis of efficacy endpoints according to biomarker status for selected arms. Thirty two patients have been registered for the study with 3 patients randomised, recruitment is ongoing. Clinical trial information: EUDRACT: 2014-002169-30.

Intra-articular treatment with triamcinolone compared with triamcinolone with hyaluronate: A randomised open-label multicentre clinical trial in 80 lame horses

2015 ◽  
Vol 48 (2) ◽  
pp. 152-158 ◽  
Author(s):  
J. C. de Grauw ◽  
M. C. Visser-Meijer ◽  
F. Lashley ◽  
P. Meeus ◽  
P. R. van Weeren
Keyword(s):  
Clinical Trial ◽  
Open Label ◽  
Multicentre Clinical Trial

Blood tumor mutational burden (bTMB) and tumor PD-L1 as predictive biomarkers of survival in MYSTIC: First-line durvalumab (D) ± tremelimumab (T) versus chemotherapy (CT) in metastatic (m) NSCLC.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 9016-9016 ◽  
Author(s):  
Naiyer A. Rizvi ◽  
Byoung Chul Cho ◽  
Niels Reinmuth ◽  
Ki Hyeong Lee ◽  
Alexander Luft ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Predictive Biomarkers ◽  
Predictive Biomarker ◽  
Small Sample ◽  
First Line ◽  
Open Label ◽  
Mutational Burden ◽  
Tumor Mutational Burden ◽  
Small Sample Sizes ◽  
Clinical Trial Information

9016 Background: MYSTIC, an open-label, Ph3 trial of first-line D (anti-PD-L1) ± T (anti-CTLA-4) vs platinum-based CT, showed an improvement in OS with D vs CT in pts with tumor cell PD-L1 expression ≥25% (PD-L1 TC ≥25%; HR 0.76 [97.54% CI 0.56–1.02], p = 0.036). Exploratory analyses showed bTMB was a predictive biomarker for OS with D±T vs CT. We report further exploratory analyses of OS according to PD-L1 and bTMB. Methods: Immunotherapy/CT-naïve pts with mNSCLC were randomized (1:1:1) to D, D+T or CT. bTMB levels (mut/Mb) were evaluated with the GuardantOMNI platform (Guardant Health), and PD-L1 TC expression with the VENTANA PD-L1 (SP263) IHC assay. Results: D improved OS vs CT in pts with PD-L1 TC ≥25% across bTMB levels (PD-L1 TC ≥25%/bTMB≥20 HR 0.79 [95% CI 0.45, 1.39]; PD-L1 TC ≥25%/bTMB < 20 HR 0.64 [95% CI 0.45, 0.90]). In contrast, D+T improved OS vs CT in pts with bTMB≥20 across different PD-L1 TC expression levels (Table; PD-L1 TC ≥25%/bTMB≥20 HR 0.44 [95% CI 0.23, 0.84]; PD-L1 TC < 1%/bTMB≥20 HR 0.42 [95% CI 0.17, 0.97]). Additional cutoffs and outcomes in subgroups defined by both biomarkers will be presented. Conclusions: These exploratory analyses from MYSTIC support PD-L1 TC expression as an appropriate predictive biomarker for OS with D vs CT, while suggesting bTMB as a predictive biomarker for OS with D+T in mNSCLC. These biomarkers appear to be independent and both may be important for mNSCLC treatment decisions. Interpretation of these data may be limited by small sample sizes; further investigations are warranted. Clinical trial information: NCT02453282. [Table: see text]

Phase III randomized sequential open-label study to evaluate the efficacy of FOLFOX + panitumumab followed by FOLFIRI + bevacizumab (Sequence 1) versus FOLFOX+ bevacizumab followed by FOLFIRI + panitumumab (Sequence 2) in untreated patients with wild-type RAS metastatic, primary left (L)-sided, unresectable colorectal cancer (CRC): The CR-SEQUENCE.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. TPS3618-TPS3618
Author(s):  
Ramon Salazar ◽  
Alfredo Carrato ◽  
Teresa Garcia Garcia ◽  
Javier Gallego Plazas ◽  
Auxiliadora Gómez-España ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Clinical Trial ◽  
Objective Response ◽  
Primary Objective ◽  
Phase Iii ◽  
Second Line ◽  
Wild Type ◽  
First Line ◽  
Open Label ◽  
Anti Vegf

TPS3618 Background: Both anti-EGFR and anti-VEGF therapies have shown clinical benefit when they are added in first and second-line in L-sided CRC. The conflicting results in anti-VEGF vs. anti-EGFR studies (FIRE-3, PEAK and CALGB/SWOG 80405 studies) suggest that the sequence of targeted therapies added to FOLFOX or FOLFIRI regimens in first- and second-line treatment could be an important factor in the overall survival (OS) of mCRC patients. Currently, there are no randomized data on the sequential use of an anti-EGFR followed by an anti-VEGF or vice versa. Therefore, the aim of this randomized clinical trial is to compare the efficacy of two treatment sequences, panitumumab followed by bevacizumab versus bevacizumab followed by panitumumab in combination with FOLFOX chemotherapy in first-line and with FOLFIRI in second-line in patients with wild-type RAS, primary L-sided, metastatic colorectal cancer (mCRC). Methods: A phase III, multicentre, open-label and randomized two-arm clinical trial. Untreated patients with wild-type RAS mCRC (determined locally), primary L-sided and unresectable will be screened for this trial. Eligible patients will be randomized 1:1 to receive first-line (1L) panitumumab plus FOLFOX and then bevacizumab plus FOLFIRI as second-line (2L) treatment (Seq. 1) or bevacizumab plus FOLFOX as 1L and then panitumumab plus FOLFIRI as 2L treatment (Seq. 2). Randomization will be stratified by number of metastatic organs involved (1 vs > 1). Primary objective is the comparison of the progression free survival (PFS) rate at 35 months (m) of Seq 1 vs Seq. 2. Secondary objectives: PFS from randomization to 2nd progression or death, OS rate at 35 months and OS of Seq. 1 vs Seq. 2; PFS, objective response rate, disease control rate, early tumour shrinkage, Depth of Response, duration and time to response and safety in 1L treatment and in 2L treatment in each Sequence arm. Exploratory objectives: impact of baseline biomarkers predictive of the efficacy in each Sequence arm and the clinical impact of clonal dynamics by longitudinal analysis of circulating tumour deoxyribonucleic acid (ctDNA) in plasma. The trial is in progress; 28 of up to 370 planned patients have been recruited at the end of January 2019 (first patient in 31 October 2018). Clinical trial information: NCT03635021.

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