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Digestive System Neoplasms clinical trials

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NCT ID: NCT04197310 Completed - Clinical trials for Neuroendocrine Tumors

Cabozantinib and Nivolumab for Carcinoid Tumors

Start date: December 26, 2019
Phase: Phase 2
Study type: Interventional

This research study, is studying the combination of cabozantinib and nivolumab in treating advanced carcinoid tumors. - Carcinoid tumor is another term used to refer to neuroendocrine tumors that arise in organs such as the gastrointestinal tract, lungs, or thymus.

NCT ID: NCT04145297 Completed - Clinical trials for Gastrointestinal Neoplasms

Ulixertinib (BVD-523) and Hydroxychloroquine in Patients w Advanced MAPK-Mutated Gastrointestinal Adenocarcinomas

UTAH
Start date: March 17, 2020
Phase: Phase 1
Study type: Interventional

Open-label dose escalation of Ulixertinib combined with fixed dose of hydroxychloroquine.

NCT ID: NCT04137289 Completed - Cholangiocarcinoma Clinical Trials

A Study to Find a Safe and Effective Dose of BI 905711 in Patients With Advanced Gastrointestinal Cancer

Start date: March 11, 2020
Phase: Phase 1
Study type: Interventional

Phase Ia - Explore safety and establish the maximum tolerated dose (MTD)/recommended dose levels for phase Ib expansion phase of BI 905711 based on the frequency of patients experiencing dose limiting toxicities (DLTs) during the MTD evaluation period. The MTD evaluation period is defined as the first two treatment cycles (from first dose administration until the day preceding the third dose administration or end of REP in case of discontinuation before start of Cycle 3). Phase Ia - Explore pharmacokinetics/pharmacodynamics, and efficacy to guide the determination of a potentially effective dose range for phase Ib in the absence of MTD. Phase Ib - Evaluate efficacy and safety of BI 905711 at a potentially effective dose range and determine the Recommended Phase 2 Dose (RP2D)

NCT ID: NCT04080843 Completed - Colorectal Cancer Clinical Trials

Anlotinib Hydrochloride Capsules Combined With CAPEOX in RAS and BRAF Wild-type mCRC Patients

ALTER-C-002
Start date: November 15, 2019
Phase: Phase 2
Study type: Interventional

This is an Open, Single Arm, Exploratory and Phase II Clinical Trial of Anlotinib Hydrochloride Capsules Combined With CAPEOX in RAS and BRAF wild-type patients with Metastatic Colorectal Carcinoma(CRC) as 1st Therapy. After 6 cycles of combined therapy, patients will receive capecitabine and anlotinib as maintenance therapy until tumor progression.In order to observe and evaluate the efficacy and safety of Anlotinib Hydrochloride Capsules combined with CAPEOX in treatment of patients with mCRC. The patients who are pathologically confirmed as RAS and BRAF wild-type mCRC will be enrolled. Condition or disease Invention/treatment Phase Colorectal Cancer Drug: Anlotinib Hydrochloride Drug: Capecitabine Drug: Oxaliplatin Phase 2

NCT ID: NCT04010227 Completed - Clinical trials for Gastrointestinal Neoplasms

Telephone Support for Advanced Gastrointestinal Cancer Patients and Caregivers

Start date: September 16, 2019
Phase: N/A
Study type: Interventional

This trial tests telephone-based Acceptance and Commitment Therapy (ACT), a type of psychotherapy, to reduce fatigue interference with activities, mood, and cognition in advanced gastrointestinal (GI) cancer patients and family caregiver burden. ACT includes mindfulness exercises (e.g., meditations, performing activities with greater awareness), identifying personal values (e.g., family, spirituality), and engaging in activities consistent with these values. A total of 40 patient-caregiver dyads were randomly assigned in equal numbers to either the ACT intervention or an education/support condition. Dyads in both conditions participated in six weekly 50-minute telephone sessions. Outcomes were assessed at baseline, 2 weeks post-intervention, and 3 months post-intervention. The investigators hypothesize that ACT will lead to improved primary and secondary outcomes as compared to education/support. Study findings will inform a large-scale trial of intervention efficacy.

NCT ID: NCT03763526 Completed - Clinical trials for Digestive System Cancer

Association Between Perioperative Nutritional Status and Surgical Outcome in Digestive System Cancer Patients

Start date: December 20, 2018
Phase:
Study type: Observational

Malnutrition is a common problem in cancer patients. It negatively influences patients' prognosis and quality of life. In gastrointestinal patients, it is also caused by insufficient food intake due to dysphagia, lack of appetite, nausea, vomiting, impaired digestion and absorption. Furthermore, influence of prior oncologic treatment (surgery, chemotherapy, and radiotherapy), have been associated with prolonged hospital stay, more postoperative complications and low survival outcome1-4. So, the proper assessment of nutrition status to detect perioperative malnutrition may allow appropriate nutritional therapy and improve survival5. However, the important factor which prolongs survival rate is good preoperative nutrition status because it effects the postoperative nutrition outcome. The objective of this study is to correlate the association between pre- and postoperative nutrition status and surgical outcomes. The Nutrition Alert Form (NAF) is a clinical tool for determining nutritional status. The NAF was modified from Subjective Global Assessment (SGA)6, and it is easy to use and does not require nutritional expertise based on laboratory and physical examination. Therefore, the NAF has been used extensively for screening of malnutrition in hospitalized Thai patients and it can classify the nutritional status into three groups : NAF-A (Normal-Mild malnutrition), NAF-B (Moderate malnutrition), NAF-C (Severe malnutrition)

NCT ID: NCT03722511 Completed - Diarrhea Clinical Trials

Evaluating an Amino Acid Based Medical Food w/ Diarrhea in Carcinoid Syndrome & Other NETs

Start date: December 6, 2018
Phase: Phase 2
Study type: Interventional

Primary Objective: To assess how an amino acid based medical food (Enterade®) helps maintain the intestine's ability to absorb and retain fluids, leading to a reduction in diarrhea due to Neuroendocrine Tumors (NET) and/or Carcinoid Syndrome. This improvement in the absorption will be assessed in part by evaluating changes in average daily stool frequency from baseline in patients receiving Enterade®. Each subject serves as his or her own control. Secondary Objectives: - To assess subject reported health-related quality of life in subjects before and after compound administration. - To characterize the side effect profile and tolerability of Enterade® as measured by the number of total 8-oz Enterade® bottles consumed throughout the trial, and average drinks per day. - To evaluate changes in serum electrolytes before and after administration of Eenterade®. - To assess intravenous fluid requirement and/or hospitalization for dehydration secondary to diarrhea between control observation period and active Enterade® period. - To evaluate difference in utilization of standard-of-care anti-diarrheal medications between control observation period and Enterade® period. - To compare subjective feeling of bloating and flatulence before and after administration of Enterade®. - To evaluate changes in patient weight before and after administration of Enterade®.

NCT ID: NCT03717298 Completed - Pancreatic Cancer Clinical Trials

Evaluation of Ocoxin-Viusid® in Advanced Pancreatic Adenocarcinoma

Start date: October 30, 2018
Phase: Phase 2
Study type: Interventional

The investigators hypothesized that with the administration of the nutritional supplement Ocoxin-Viusid® is expected to improve the quality of life and enhance tolerance to chemotherapy in at least 70% of patients diagnosed with advanced pancreatic adenocarcinoma, treated at the "Hermanos Ameijeiras" Surgical Clinical Hospital. Phase II clinical trial, open, multicenter, nonrandomized.

NCT ID: NCT03674294 Completed - Clinical trials for Gastrointestinal Neoplasms

Aprepitant Triple Therapy for the Prevention of CINV in Nondrinking and Young Women Who Received Moderately Emetogenic Chemotherapy

CINV
Start date: August 4, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to study whether adding Aprepitant to Palonosetron and dexamethasone can further prevent the incidence and severity of nausea and vomiting caused by FOLFIRI or FOLFOX chemotherapy regimen among gastrointestinal malignancy patients with high risk factors of chemotherapy-associated adverse events.

NCT ID: NCT03559543 Completed - Clinical trials for Gastrointestinal Neoplasms

Evaluation of Ocoxin®-Viusid® in Metastatic Colorectal Adenocarcinoma

Start date: October 25, 2018
Phase: Phase 2
Study type: Interventional

The research product, registered as a nutritional supplement (Ocoxin®, oral solution), manufactured by Laboratorios Catalysis S. L., comes in the form of single-dose vials of 30 ml. It will be used at a rate of 60 ml daily (1 vial every 12 hours). Our main objective is To evaluate the effect of Ocoxin®-Viusid® on the quality of life of patients with metastatic colorectal adenocarcinoma. Our hypothesis is that the administration of the nutritional supplement Ocoxin®-Viusid® it is expected to improve the quality of life and enhance tolerance to chemotherapy in at least 70% of patients.