Apatinib as Maintenance Therapy After First-line Chemotherapy(DC for 4 Cycles) in Postoperative Recurrence/Metastasis Progressive Gastric Cancer

NCT02509806 | Unknown Phase 2

• 1 other identifier: Ahead-G309
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the efficacy and safety of apatinib as maintenance therapy after first-line chemotherapy in Postoperative Recurrence / Metastasis Progressive Gastric Cancer.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  An expected average of 12 weeks

Study Arms (2)

Apatinib Maintenance Therapy After First-line Chemotherapy

EXPERIMENTAL

Apatinib Mesylate Tablets 500 mg qd p.o. after DC First-line Chemotherapy (Docetaxel 60-85mg/m2 i.v. d1, Cisplatin 60-75mg/m2 i.v. d1, q21d）

Drug: Apatinib

No Intervention After First-line Chemotherapy

NO INTERVENTION

No Intervention after DC First-line Chemotherapy (Docetaxel 60-85mg/m2 i.v. d1, Cisplatin 60-75mg/m2 i.v. d1, q21d）

Interventions

Apatinib DRUG

Apatinib Mesylate Tablets 500 mg qd p.o.

Also known as: ATAN

Apatinib Maintenance Therapy After First-line Chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 to75 years old;
• Histologically proven progressive gastric cancer. All pts were received D2 gastrectomy and recurrence / metastasis occured;
• Complete 4 cycles DC first-line chemotherapy and no and no disease progression occurred. DC: Docetaxel 60-85mg/m2 iv d1, Cisplatin 60-75mg/m2 iv d1, q21d;
• ECOG PS of 0-1;
• Major organ function has to meet the following criteria:
• ANC ≥ 1.5 × 109 / L; HB ≥ 90g / L; PLT ≥ 100 × 109 / L; Bilirubin \<1.5 times the upper limit of normal (ULN); ALT and AST \<2.5 × ULN; liver metastases, if any, the ALT and AST\<5 × ULN;
• An expected survival of ≥ 3 months;
• 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.
• Patient has to voluntarily join the study and sign the Informed Consent Form for the study;

You may not qualify if:

• Confirmed that apatinib and/or its accessories allergy;
• 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 II cardiac dysfunction;
• Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
• 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 vomiting blood in the past 2 months;
• Abnormal Coagulation (INR\>1.5、APTT\>1.5 UNL), with tendency of bleed;
• Associated with CNS (central nervous system) metastases;
• Pregnant or lactating women;
• Pts with other malignant tumor within 5 years(except cured skin basal cell carcinoma and cervical carcinoma);
• With psychotropic drug abuse history and can't get rid of or mental disorder patients;
• Participated in other clinical trials within 4 weeks.
• Pts received VEGFR inhibitor treatment(i.e. sorafenib, sunitinib);
• Any other condition that might place the patient at undue risk or preclude a patient from completing the study;
• Other conditions regimented at investigators' discretion.

Sponsors & Collaborators

• Hebei Medical University: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

Fourth Affiliated Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050011, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

apatinib

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Zhao Qun, MD

CONTACT

0311-86543035; zhaoqun516@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investgator

Study Record Dates

• First Submitted: July 26, 2015
• First Posted: July 28, 2015
• Study Start: July 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: October 9, 2017

Record last verified: 2017-10

Locations

CN (1)