Loading clinical trials...

UNKNOWNNA

Clinical Study on Treatment of Apatinib Mesylate in First-line Maintenance of Advanced Gastric Cancer

Clinical Study on Treatment of Apatinib Mesylate in First-line Maintenance of Advanced Gastric Cancer -- Multicenter, Open, One Arm Exploratory Study

NCT03255811•DongMa

View on ClinicalTrials.gov

Summary

At present, apatinib was approved for the treatment of advanced gastric cancer after second-line or gastroesophageal junction adenocarcinoma, is in the second one, experience of medication, clinical data, no chemotherapy so now intends to carry out 40 cases of small sample exploratory research, in the conventional chemotherapy after the onset, with APA for Nigeria maintenance treatment, with a preliminary understanding of apatinib in first-line advanced gastric cancer to maintain the efficacy and safety of the treatment, and explore the feasibility of anti generate small molecule targeted therapy in advanced gastric cancer vascular pattern.

Detailed Description

The incidence of gastric cancer in China is high, and there is no standard first-line chemotherapy regimen for advanced gastric cancer. Second-line therapy usually involves first-line treatment, without the use of drugs for combination or monotherapy, and no uniform treatment. Apatinib approved provides a good solution to this problem, but this study is in limit of validity standard after all into the row, not very good reaction in clinical practice for APA imatinib reality in the treatment of advanced gastric cancer. Therefore, it is necessary to make a prospective product study to understand the gap between clinical practice and research results. This study can evaluate apatinib in treatment of advanced gastric or gastroesophageal junction safe and effective parts of adenocarcinoma in clinical practice, and the specific usage (such as dose and period). The results of this study can help the future clinical practice specification of apatinib parts for the treatment of adenocarcinoma with advanced gastric or gastroesophageal reflux, the advanced gastric or gastroesophageal adenocarcinoma patients with parts get treatment more safe and effective in the treatment of. At present, apatinib was approved for the treatment of advanced gastric cancer after second-line or gastroesophageal junction adenocarcinoma, is in the second one, experience of medication, clinical data, no chemotherapy so now intends to carry out 40 cases of small sample exploratory research, in the conventional chemotherapy after the onset, with APA for Nigeria maintenance treatment, with a preliminary understanding of apatinib in first-line advanced gastric cancer to maintain the efficacy and safety of the treatment, and explore the feasibility of anti generate small molecule targeted therapy in advanced gastric cancer vascular pattern.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. age: more than 18 years old, male or female;
•2. histologically confirmed advanced gastric or gastroesophageal junction adenocarcinoma, stomach with measurable lesions (spiral CT scan is more than 10mm, meet the RECIST standard 1.1);
•3. inoperable, locally advanced, recurrent or metastatic adenocarcinoma of the stomach or esophagogastric junction;
•4. first-line chemotherapy (oxaliplatin / cisplatin / paclitaxel combined with fluorouracil / either drug, docetaxel or S-1 / capecitabine), efficacy evaluation of SD or CR or PR may, from the last chemotherapy cycle time is not more than 28 days;
•5. when evaluating the maximum response rate of chemotherapy (chemotherapy is not less than 4 cycles), enter maintenance therapy. (maximum response rate: compared with the previous curative effect evaluation, the target lesion no longer continued to shrink);
•6. ECOG PS:0-1 points;
•7. baseline blood routine and biochemical parameters met the following criteria: Hemoglobin is larger than 80g/L,
•* the absolute neutrophil count (ANC) = 1.5 \* 109/L, Over 90 \* 109/L platelets,
•* ALT, AST less than 2.5 times the upper limit of normal value, Equal to or less than 5 times the upper limit of normal (liver metastasis),
•* the serum total bilirubin is less than 1.5 times the upper limit of normal value, Serum creatinine. Less than 1.5 times the upper limit of normal value, Serum albumin is more than 30g/L;
+3 more criteria

Exclusion Criteria

•1. confirmed of apatinib and / or its accessories allergy;
•2. with high blood pressure and the antihypertensive drug treatment can not be reduced to the normal range (\>140 systolic blood pressure mmHg, diastolic blood pressure \>90 mmHg), with I level above grade I coronary heart disease, arrhythmia (including QTc prolongation \> 450 male MS, female MS \> 470) and grade I heart function insufficiency; patients with positive urinary protein;
•3. , there are a variety of factors that affect oral medication (such as inability to swallow, nausea, vomiting, chronic diarrhea, and intestinal obstruction); The 4. has a clear tendency in patients with gastrointestinal bleeding, including the following: local active ulcerative lesions, and fecal occult blood (+ +) can not be enrolled; 2 months melena, hematemesis history; for fecal occult blood (+) and gastric primary tumor without surgical resection. And for gastroscopy, such as gastric cancer, and researchers believe that may occur in massive hemorrhage of digestive tract were;
•5\. coagulation dysfunction (INR\>1.5, APTT\>1.5, ULN), with bleeding tendency; 6. patients with central nervous system metastasis; 7. pregnant or lactating women; A patient with other malignancies within 8.5 years; 9. patients who have history of psychotropic substance abuse and are unable to quit or have mental disorders; Patients who participated in other clinical trials within 10.4 weeks; 11. received VEGFR inhibitors, such as Sola Fini and sunitinib therapy; 12. according to the researcher's judgment, there are patients who seriously endanger the safety of patients or affect the patients who complete the study; 13., the researchers considered unsuitable for inclusion.

Locations (1)

Guangdong General Hospital

Guangzhou, Guangdong, China

Key Dates

Start Date

March 25, 2017

Primary Completion Date

January 25, 2019

Completion Date

March 25, 2019

Last Updated

August 21, 2017

Enrollment

ESTIMATED participants

Conditions

Advanced Gastric Cancer

Interventions

apatinib

DRUG

Optimal Methods to Characterize ADC Resistance in Solid Tumors and Identify Clinically Useful Biomarkers

NCT07259226

Advanced Breast CancerAdvanced Gastric Cancer+2 more

View study

RECRUITINGPHASE2

Safety and Efficacy of SHR2554 Combined With Other Antitumor Therapies in Gastric or Gastro-oesophageal Junction Adenocarcinoma

NCT07102901

Advanced Gastric CancerMetastatic Gastric Cancer+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 21, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Clinical Study on Treatment of Apatinib Mesylate in First-line Maintenance of Advanced Gastric Cancer

Inclusion Criteria

Exclusion Criteria

Optimal Methods to Characterize ADC Resistance in Solid Tumors and Identify Clinically Useful Biomarkers

Safety and Efficacy of SHR2554 Combined With Other Antitumor Therapies in Gastric or Gastro-oesophageal Junction Adenocarcinoma

First-Line and Neoadjuvant Immunotherapy for Gastric Cancer

Machine Learning-driven Noninvasive Screening of Transcriptomics Liquid Biopsies for Early Diagnosis of Occult Peritoneal Metastases in Locally Advanced Gastric Cancer

SHR-A1811 for Subjects With Her2-positive Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on or After First-line Anti-HER2 Therapy-containing Regimen

Evaluation of Pressurized Intraperitoneal Aerosol Chemotherapy With VRT106 Versus PIPAC in Patients With Advanced Gastric Cancer and PeritonealMetastasis: A Prospective, Multicenter, Open-Label, Randomized Controlled Trial