Back to resultsA Study of Apatinib Combined With S1 in Patients With Advanced Gastric Cancer
Primary Purpose
Gastric Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Apatinib
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring gastric cancer, gastroesophageal junction cancer, Apatinib, S1
Eligibility Criteria
Inclusion Criteria:
- Adult patients, aged between 18 and 75 years old;
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2;
- 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;
- Failure or intolerance to at least one prior line of systemic chemotherapy regimen;
- 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);
- Expected survival of ≥ 12 weeks.
Exclusion Criteria:
- 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;
- 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;
- Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
- Previous treatment with VEGFR inhibitor (i.e. Apatinib, sorafenib, sunitinib);
- With psychotropic drug abuse history and can't get rid of or mental disorder patients;
- Associated with CNS (central nervous system) metastases;
- Active bacterial infections;
- Pregnant or breast-feeding women;
- Any other condition that might place the patient at undue risk or preclude a patient from completing the study.
Sites / Locations
- Beijing Friendship HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Apatinib plus S1
Arm Description
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
Outcomes
Primary Outcome Measures
Progression-free survival (PFS)
defined as the time from randomize to progression or death; RECIST guidelines were used to define all responses after patients had received every 6 weeks of therapy
Secondary Outcome Measures
Overall survival (OS)
defined as the time from randomize to death
Safety (incidence of adverse events)
incidence of adverse events
Quality of life(QoL)
as measured by the European Organization for Research and Treatment of Cancer questionnaire (EORTC QLQ C30)
Full Information
NCT ID
NCT03271073
First Posted
August 31, 2017
Last Updated
August 31, 2017
Sponsor
Beijing Friendship Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03271073
Brief Title
A Study of Apatinib Combined With S1 in Patients With Advanced Gastric Cancer
Official Title
A Exploratory Study of Apatinib in Combination With S1 in Patients With Advanced Gastric Evaluating the Efficacy and Safety
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2016 (Actual)
Primary Completion Date
July 31, 2018 (Anticipated)
Study Completion Date
January 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Friendship Hospital
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
gastric cancer, gastroesophageal junction cancer, Apatinib, S1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Apatinib plus S1
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Apatinib
Other Intervention Name(s)
S1
Intervention Description
Apatinib,500mg,qd,po,d1-21;S1,40mg,bid,d1-14;every 21days a cycle
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
defined as the time from randomize to progression or death; RECIST guidelines were used to define all responses after patients had received every 6 weeks of therapy
Time Frame
Approximately 1 year
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
defined as the time from randomize to death
Time Frame
Approximately 2 years
Title
Safety (incidence of adverse events)
Description
incidence of adverse events
Time Frame
Approximately 1 year
Title
Quality of life(QoL)
Description
as measured by the European Organization for Research and Treatment of Cancer questionnaire (EORTC QLQ C30)
Time Frame
Approximately 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients, aged between 18 and 75 years old;
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2;
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;
Failure or intolerance to at least one prior line of systemic chemotherapy regimen;
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);
Expected survival of ≥ 12 weeks.
Exclusion Criteria:
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;
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;
Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
Previous treatment with VEGFR inhibitor (i.e. Apatinib, sorafenib, sunitinib);
With psychotropic drug abuse history and can't get rid of or mental disorder patients;
Associated with CNS (central nervous system) metastases;
Active bacterial infections;
Pregnant or breast-feeding women;
Any other condition that might place the patient at undue risk or preclude a patient from completing the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Deng, M.D.
Phone
+8613426136152
Email
dengweiwei@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhigang Bai, M.D.
Phone
+8613126617140
Email
bai_zhg@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Deng, M.D.
Organizational Affiliation
Beijing Friendship Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Deng, M.D.
Phone
+8613426136152
Email
dengweiwei@126.com
First Name & Middle Initial & Last Name & Degree
Zhigang Bai, M.D.
Phone
+8613126617140
Email
bai_zhg@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of Apatinib Combined With S1 in Patients With Advanced Gastric Cancer
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