Suspended

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

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What is being tested

Apatinib

Drug
Who is being recruted

Digestive System Diseases+5

+ Digestive System Neoplasms

+ Gastrointestinal Diseases

From 18 to 75 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2 & 3
Interventional
Study Start: July 2015
See protocol details

Summary

Principal SponsorHebei Medical University
Study ContactZhao Qun, MD
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2015

Actual date on which the first participant was enrolled.

Eligible patients will receive apatinib treatment(500mg qd p.o. q28d) until until disease progression or intolerable toxicity or patients withdrawal of consent after 4 cycles of DC first-line chemotherapy or only DC first-line chemotherapy.

Official TitleApatinib as Maintenance Therapy After First-line Chemotherapy(DC for 4 Cycles) in Postoperative Recurrence/Metastasis Progressive Gastric Cancer
NCT02509806
Principal SponsorHebei Medical University
Study ContactZhao Qun, MD
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

48 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsNeoplasmsNeoplasms by SiteStomach DiseasesStomach Neoplasms

Criteria

Inclusion Criteria: 1. Age: 18 to75 years old; 2. Histologically proven progressive gastric cancer. All pts were received D2 gastrectomy and recurrence / metastasis occured; 3. 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; 4. ECOG PS of 0-1; 5. 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; 6. An expected survival of ≥ 3 months; 7. 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. 8. Patient has to voluntarily join the study and sign the Informed Consent Form for the study; Exclusion Criteria: 1. Confirmed that apatinib and/or its accessories allergy; 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 II cardiac dysfunction; 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 vomiting blood in the past 2 months; 5. Abnormal Coagulation (INR\>1.5、APTT\>1.5 UNL), with tendency of bleed; 6. Associated with CNS (central nervous system) metastases; 7. Pregnant or lactating women; 8. Pts with other malignant tumor within 5 years(except cured skin basal cell carcinoma and cervical carcinoma); 9. With psychotropic drug abuse history and can't get rid of or mental disorder patients; 10. Participated in other clinical trials within 4 weeks. 11. Pts received VEGFR inhibitor treatment(i.e. sorafenib, sunitinib); 12. Any other condition that might place the patient at undue risk or preclude a patient from completing the study; 13. Other conditions regimented at investigators' discretion.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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)

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Fourth Affiliated Hospital of Hebei Medical University

Shijiazhuang, ChinaOpen Fourth Affiliated Hospital of Hebei Medical University in Google Maps
SuspendedOne Study Center