A Study of Apatinib Combined With S1 in Patients With Advanced Gastric Cancer

NCT ID: NCT03271073

Last Updated: 2017-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-01

Study Completion Date

2019-01-31

Brief Summary

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Antiangiogenesis therapy plays an important role in cancer treatment. Apatinib showed good safety and efficacy as third-line therapy for advanced gastric cancer.We conducted this trial to investigate the safety and efficacy of apatinib combined with S1 after failure of first-line chemotherapy in advanced gastric cancer or gastroesophageal junction carcinoma patients.

Detailed Description

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Conditions

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Gastric Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Apatinib plus S1

patients with advanced gastric cancer enrolled after failure of first-line systemic chemotherapy will be given Apatinib plus S1 till progressive disease,death or non-tolerable toxicity

Group Type EXPERIMENTAL

Apatinib

Intervention Type DRUG

Apatinib,500mg,qd,po,d1-21;S1,40mg,bid,d1-14;every 21days a cycle

Interventions

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Apatinib

Apatinib,500mg,qd,po,d1-21;S1,40mg,bid,d1-14;every 21days a cycle

Intervention Type DRUG

Other Intervention Names

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S1

Eligibility Criteria

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Inclusion Criteria

1. Adult patients, aged between 18 and 75 years old;
2. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2;
3. Histologically confirmed advanced or metastatic adenocarcinoma of gastric cancer(AGC) , including adenocarcinoma of the gastroesophageal junction ,one or more measurable or nonmeasurable evaluable lesions per RECIST 1.1;
4. Failure or intolerance to at least one prior line of systemic chemotherapy regimen;
5. Adequate liver, renal, heart, and bone-marrow functions ( hemoglobin≥ 80g/L, platelets ≥ 100 × 10\*9/L, neutrophil ≥1.5 × 10\*9/L, total bilirubin ≤1.5 ×ULN, and serum transaminase≤2.5×ULN);
6. Expected survival of ≥ 12 weeks.

Exclusion Criteria

1. 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 I cardiac dysfunction;
2. 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;
3. Abnormal Coagulation (INR\>1.5、APTT\>1.5 UNL), with tendency of bleed;
4. Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
5. Previous treatment with VEGFR inhibitor (i.e. Apatinib, sorafenib, sunitinib);
6. With psychotropic drug abuse history and can't get rid of or mental disorder patients;
7. Associated with CNS (central nervous system) metastases;
8. Active bacterial infections;
9. Pregnant or breast-feeding women;
10. Any other condition that might place the patient at undue risk or preclude a patient from completing the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhongtao Zhang

assistant dean, professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wei Deng, M.D.

Role: PRINCIPAL_INVESTIGATOR

Beijing Friendship Hospital

Locations

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Beijing Friendship Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wei Deng, M.D.

Role: CONTACT

+8613426136152

Zhigang Bai, M.D.

Role: CONTACT

+8613126617140

Facility Contacts

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Wei Deng, M.D.

Role: primary

+8613426136152

Zhigang Bai, M.D.

Role: backup

+8613126617140

Other Identifiers

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AHEAD-Y001

Identifier Type: -

Identifier Source: org_study_id

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