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

Gastric Cancer Clinical Trial

Official title:

A Exploratory Study of Apatinib in Combination With S1 in Patients With Advanced Gastric Evaluating the Efficacy and Safety

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03271073
• Other study ID #: AHEAD-Y001
• Status: Recruiting
• Phase: Phase 2
• First received: August 31, 2017
• Last updated: August 31, 2017
• Start date: February 1, 2016
• Est. completion date: January 31, 2019

Study information

• Verified date: August 2017
• Source: Beijing Friendship Hospital
• Contact: Wei Deng, M.D.
• Phone: +8613426136152
• Email: dengweiwei[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 31, 2019
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Beijing Friendship Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Approximately 1 year
Secondary	Overall survival (OS)	defined as the time from randomize to death	Approximately 2 years
Secondary	Safety (incidence of adverse events)	incidence of adverse events	Approximately 1 year
Secondary	Quality of life(QoL)	as measured by the European Organization for Research and Treatment of Cancer questionnaire (EORTC QLQ C30)	Approximately 2 years