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Capecitabine clinical trials

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NCT ID: NCT04720131 Completed - Clinical trials for Biliary Tract Cancer

Camrelizumab Combined With Apatinib and Capecitabine in Patients With Advanced Biliary Tract Cancer.

Start date: January 1, 2021
Phase: Phase 2
Study type: Interventional

Biliary tract cancer (BTC) is a series of rare malignancies with poor overall prognosis. Radical surgery the preferred treatment option, but most patients have lost the opportunity of surgery at the time of diagnosis. At present, there are limited systematical treatment options for biliary tract cancer, with poor efficacy and short duration of responses. In the past few years, immune checkpoint inhibitors (ICIs) therapy has gradually been added to the advanced biliary comprehensive treatment. However, in view of the low incidence and high heterogeneity of BTC, more large number of clinical trials and practices need to be carried out, and the effective combination regimens and predictive biomarkers need to be explored. This study is a single-arm, open-label, prospective cohort study, combining Camrelizumab with apatinib and capecitabine as the first-line or second-line treatment for patients with advanced biliary tract cancer. The study aims to explore the efficacy and safety of the combination regimen, and try to find biomarkers that can guild treatment. In this study, 34 patients were enrolled by the Simon's two-stage design, with the objective response rate as the primary endpoint and the disease control rate, progression-free survival, overall survival and safety as secondary endpoints. It is expected that the three-drug combination regimen will have significant efficacy and manageable adverse reactions, and predictive biomarkers can be found.

NCT ID: NCT03889626 Not yet recruiting - Neoplasms Clinical Trials

The Maintenance Treatment of Apatinib/Capecitabine Versus Observation in Advanced Gastric Cancer

Start date: March 22, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and tolerability of the maintenance treatment of Apatinib/Capecitabine after fluorouracil and platinum based first-line chemotherapy in advanced gastric cancer.

NCT ID: NCT03500380 Active, not recruiting - Breast Neoplasms Clinical Trials

A Study of RC48-ADC Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer With or Without Liver Metastases

Start date: April 24, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

This is a randomized, open, parallel-controlled, multicenter, phase II/III, seamless design clinical trial to compare the efficacy and safety of RC48-ADC with capecitabine + lapatinib in locally advanced or metastatic human epidermal growth factor receptor 2 (HER2) positive breast cancer and HER2-positive advanced breast cancer with liver metastasis.

NCT ID: NCT03258099 Active, not recruiting - Solid Tumor Clinical Trials

Association of Genetic Polymorphisms With Capecitabine-based Chemotherapy Toxicities in Chinese Solid Tumor Patients

Start date: December 28, 2017
Phase:
Study type: Observational

Capecitabine is one of the most active agents in the treatment of many kinds of solid tumors. However, variability in toxicity and response remains a major problem for patients receiving capecitabine. It is general that there are many factors for individual differences of drugs in clinical application, of which genetic factors accounted for more than 20%. Toxicities of capecitabine, such as diarrhea, hand-foot syndrome or anemia, were evaluated for possible relationship with pharmacogenetic polymorphisms in several pharmacogenomics studies. Due to the levels of evidence of those studies are low and lack of sufficient research data of Chinese, it has the important significance in studying individual differences of capecitabine in toxicities, through the pharmacogenomics research. The aim of this study is to evaluating the association genetic polymorphisms with capecitabine-based chemotherapy toxicities in chinese solid tumor patients. By detecting the gene polymorphism, investigators intend to study the pharmacokinetic/pharmacogenomics (PK-PG) correlation of capecitabine and provide scientific basis for precise medication guide for people to use capecitabine.

NCT ID: NCT03079440 Completed - Clinical trials for Neuroendocrine Tumors

TEMCAP in Grade 3 and Low Ki-67 Gastroenteropancreatic Neuroendocrine Tumors

Start date: May 15, 2017
Phase: Phase 2
Study type: Interventional

GI tract including pancreas is the one of most common primary sites of neuroendocrine tumors. Current grading of neuroendocrine tumors are based on the 2010 WHO classification. This classifies grade 3 tumors as the neuroendocrine tumor with mitosis > 20 per 10 high power field or Ki-67 labeling index > 20%. Etoposide-based chemotherapy, mostly as the combination with cisplatin, has been the mainstay of the treatment for patients with grade 3 neuroendocrine tumors. However, a recent large retrospective analysis has suggested this regimen may not be effective in relatively low Ki-67 labeling index. Therefore, the investigators designed a clinical trial testing temozolomide-capecitabine combination, which has been mostly investigated in well differentiated (ie., grade 1 or 2) neuroendocrine tumors, in patients with grade 3 and low Ki-67 gastroenteropancreatic neuroendocrine tumors.

NCT ID: NCT03079427 Completed - Cholangiocarcinoma Clinical Trials

Adjuvant Capecitabine vs Gemcitabine Plus Cisplatin in Resected Extrahepatic Cholangiocarcinoma

Start date: May 15, 2017
Phase: Phase 2
Study type: Interventional

There is no proven adjuvant treatment after curative surgical resection in patients with cholangiocarcinoma, although previous meta-analysis suggested potential survival benefit of adjuvant chemotherapy or radiotherapy in patients with lymph node-positive resected cholangiocarcinoma. Despite of lack of level 1 evidence and no data which regimen is optimal, adjuvant chemotherapy is widely used in daily practice setting. Based on this background, the investigators designed the randomized phase 2 trial comparing capecitabine and gemcitabine plus cisplatin in patients with resected lymph node-positive extrahepatic cholangiocarcinoma.

NCT ID: NCT03030508 Enrolling by invitation - Colorectal Cancer Clinical Trials

Discovery and Validate of Multi-genetic Biomarkers for Capecitabine in Chinese Colorectal Patients

Start date: January 2016
Phase: N/A
Study type: Observational

At present, chemotherapy is widely used in the adjuvant treatment of colorectal cancer patients after surgery. Capecitabine is one of the main chemotherapeutic drugs. But the effect is not good enough, the adverse reaction is serious, and the individual differences were significant. The present study shows that these problems are related to the differences in the exposure of capecitabine and its metabolites in different patients. The genetic biomarkers for capecitabine include DRD, MTHFR and TYMS. Mutations in these genes directly affect the expression of metabolic enzymes involved in capecitabine and control the concentration of capecitabine and its metabolites. However, these markers have been obtained through clinical trials in the United States, and their role in predicting the effectiveness or safety of capecitabine and its metabolites has not been validated in Chinese cancer patients.The study was based on a case study of patients with colorectal cancer in China, and capecitabine as the primary postoperative chemotherapy regimen to verify whether the available biomarkers can be used to predict the effectiveness and safety of capecitabine. To clarify the effect of capecitabine on endogenous metabolites, and to study the mechanism of its effect, so as to discover new biomarkers.

NCT ID: NCT02012634 Recruiting - Breast Cancer Clinical Trials

Metronomic Chemotherapy of Capecitabine After Standard Adjuvant Chemotherapy in Operable Triple Negative Breast Cancer

MACRO
Start date: January 2013
Phase: Phase 3
Study type: Observational

A Multi-center, III Phase,Randomized Controlled Clinical Study of Capecitabine Metronomic Chemotherapy After Standard Adjuvant Chemotherapy in Operable Triple Negative Breast Cancer