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

NCT03255811 | Unknown DMC

• 1 other identifier: Gastrointestinal cancer
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Gastric Cancer

Keywords

Advanced gastric cancer apatinib Maintenance therapy

Outcome Measures

Primary Outcomes (1)

• Evaluation of apatinib mesylate tablets as first-line maintenance treatment for advanced gastric or gastroesophageal junction progression free survival site adenocarcinoma

  Progression free survival

  2 years

Study Arms (1)

The dosage regimen

EXPERIMENTAL

The chemotherapy response rate reached the maximum after 14-28 days, apatinib, 750 mg (QD), once a day, half an hour after meal (daily dosing time should be as same as possible), with warm boiling water delivery service. 28 days for a dosing cycle.

Drug: apatinib

Interventions

apatinib DRUG

Apatinib mesylate tablets treatment and to maintain the actual benefit in progression free survival.

The dosage regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age: more than 18 years old, male or female;
• 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);
• inoperable, locally advanced, recurrent or metastatic adenocarcinoma of the stomach or esophagogastric junction;
• 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;
• 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);
• ECOG PS:0-1 points;
• 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;
• more than the expected survival time in March;
• women of childbearing age must have pregnancy tests (serum or urine) within 7 days prior to admission, and the results are negative and are willing to take the appropriate method of contraception at 8 weeks after the trial and at the end of the test. For men, surgical sterilization should be applied, or consent to the appropriate method of contraception 8 weeks after the trial and at the end of the trial;
• subjects voluntarily joined the study, signed informed consent, good compliance, and followed up.

You may not qualify if:

• confirmed of apatinib and / or its accessories allergy;
• 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;
• , 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;

Sponsors & Collaborators

• DongMa: lead

Study Sites (1)

Guangdong General Hospital

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Interventions

apatinib

Study Officials

• Ma Dong, graduate

  Leading Investigator

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of gastrointestinal oncology

Model Details: 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.

Study Record Dates

• First Submitted: August 17, 2017
• First Posted: August 21, 2017
• Study Start: March 25, 2017
• Primary Completion: January 25, 2019
• Study Completion: March 25, 2019
• Last Updated: August 21, 2017

Record last verified: 2017-08

Locations

CN (1)