Apatinib as Maintenance Therapy After First Line Treatment in Locally Advanced or Metastatic Gastric Cancer

NCT ID: NCT02537171

Last Updated: 2016-08-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-10-31

Brief Summary

The study is to evaluate the efficacy of Apatinib in patients with advanced or metastatic adenocarcinoma of stomach or gastroesophageal junction.

Detailed Description

The study is to investigate the efficacy of Apatinib as maintenance therapy after first fine treatment in patients with advanced or metastatic adenocarcinoma of stomach or gastroesophageal junction through progression-free survival(PFS). Apatinib will be given to patients who have received first-line chemotherapy with an efficacy assessment of stable disease(SD), complete response(CR), or partial response(PR) after 4 cycles. Patients were randomly assigned to 750mg group or 500mg group continually until disease progression or intolerable toxicity or patients withdrawal of consent, and the sample size is 40 individuals.

Conditions

Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Apatinib 750mg group

Apatinib mesylate tablets(ATAN) is taken 750mg every day orally, half hour after breakfast with warm water. The drug is taken 4 weeks one cycle until disease progression or intolerable toxicity or death.The dose of the study drug may be modified following the occurence of a clinically significant adverse event(AE).

Group Type: ACTIVE_COMPARATOR

apatinib

Intervention Type: DRUG

Patients will be randomly assigned on a 1:1 basis to treatment with Apatinib 750mg group or Apatinib 500mg group.

Apatinib 500mg group

Apatinib Mesylate Tablets(ATAN) is taken 500mg every day orally, half hour after breakfast with warm water. The drug is taken 4 weeks one cycle until disease progression or intolerable toxicity or death.Treatment will be discontinued if the subject is unable to tolerate a daily dose of 500mg.

Group Type: ACTIVE_COMPARATOR

apatinib

Intervention Type: DRUG

Patients will be randomly assigned on a 1:1 basis to treatment with Apatinib 750mg group or Apatinib 500mg group.

Interventions

apatinib

Patients will be randomly assigned on a 1:1 basis to treatment with Apatinib 750mg group or Apatinib 500mg group.

Intervention Type: DRUG

Other Intervention Names

ATAN

Eligibility Criteria

Inclusion Criteria

1. Age≥18 years;

2. Pathologically diagnosed with advanced gastric adenocarcinoma (including gastroesophageal junction) with measurable metastases outside the stomach (≥10mm on spiral CT scan, and meet the criteria of Response Evaluation Criteria in Solid Tumors 1.1);

3. Locally advanced, recurrent or metastatic gastric or gastro-oesophageal junction adenocarcinoma;

4. Finished first-line chemotherapy (fluorouracil combined with oxaliplatin, cisplatin, paclitaxel or docetaxel) 3 weeks a cycle for 4 cycles, of which the last efficacy assessment is SD, PR or CR. No more than 28 days from the starting day of last cycle of chemotherapy;

5. Eastern Cooperative Oncology Group（ECOG）performance status 0 or 1;

6. Blood routine test and Biochemical tests:

• Hemoglobin ≥ 80g / L;
• Absolute neutrophil count (ANC) ≥ 1.5 × 109 / L;
• Platelet count≥ 90 × 109 / L;
• Alanine aminotransferase (ALT)and Aspartate aminotransferase (AST) <2.5× upper limit of normal (ULN); liver metastases, if any, the ALT and AST<5 × ULN;
• Serum total bilirubin≤1.5 × ULN;
• Serum creatinine≤1.5 × ULN;
• Serum albumin≥30g/L;

7. Life expectancy more than 3 months;

8. Voluntarily join the study and sign the Informed Consent Form for the study;

9. Pregnancy test (serum or urine) has to be performed for woman of childbearing age within 7 days before enrolment and the test result must be negative. They shall take appropriate methods for contraception during the study until the 8th week post the last administration of study drug. For men, (previous surgical sterilization accepted), shall agree to take appropriate methods of contraception during the study until the 8th week post the last administration of study drug.

Exclusion Criteria

1. Patients with a known history of allergic reactions and/or hypersensitivity attributed to apatinib or its accessories;

2. Subjects with poor-controlled arterial hypertension (systolic blood pressure> 140 mmHg and diastolic blood pressure > 90 mm Hg) despite standard medical management; Coronary heart disease greater than ClassⅠ; Ⅰ-level arrhythmia (including QT interval prolongation, for man ≥ 450 ms, for woman ≥ 470 ms) together with Class Ⅰcardiac dysfunction; Patients with positive urinary protein;

3. Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);

4. Subjects with high gastrointestinal bleeding risk, including the following conditions: local active ulcer lesions with positive fecal occult blood test (++); history of black stool, or haematemesis in the past 2 months;primary lesion in stomach with positive fecal occult blood test (+) should be evaluated by endoscopy and other potential massive haemorrhage conditions evaluated by the investigator;

5. Abnormal Coagulation (international normalized ratio>1.5, activated partial thromboplastin time>1.5 UNL), with tendency of bleeding;

6. Associated with central nervous system (CNS) metastases;

7. Pregnant or lactating women;

8. Suffering from other malignancies within 5 years;

9. History of uncontrolled psychotropic drug abuse or mental disorders;

10. Participated in other clinical study within 4 weeks;

11. Prior VEGFR inhibitor treatment,such as sorafenib and sunitinib ;

12. Concomitant disease conditions judged by investigator that may seriously affect subject's safety or affect the study completion;

13. Other cases that the researcher found ineligible

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xu jianming, M.D.

Role: PRINCIPAL_INVESTIGATOR

307 Hospital of PLA

Locations

307 Hospital of PLA

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xu jianming, M.D.

Role: CONTACT

jmxu2003@yahoo.com

+861066947178

Facility Contacts

Xu jianming

Role: primary

jmxu2003@yahoo.com

+861066947178

Other Identifiers

AHEAD-G303

Identifier Type: -

Identifier Source: org_study_id