Apatinib in Combination With S-1 as First-Line Treatment in Patients With Advanced Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

Apatinib in Combination With S-1 as First-Line Treatment in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02525237
• Other study ID #: Ahead-G316
• Status: Not yet recruiting
• Phase: Phase 2
• First received: August 11, 2015
• Last updated: August 14, 2015
• Start date: August 2015
• Est. completion date: August 2017

Study information

• Verified date: August 2015
• Source: Qingdao Municipal Hospital
• Contact: Xiaochun Zhang, MD, PhD
• Phone: +86 0532 88905767
• Email: zxc96701[@]126.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of Apatinib combined with S-1 as first-line therapy for patients with advanced gastric or gastroesophageal junction adenocarcinoma.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: August 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adult patients, aged =18 years;

2. Histologically confirmed adenocarcinoma of the stomach with inoperable locally advanced or recurrent and/or metastatic disease;

3. Measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1);

4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 3;

5. No previous chemotherapy for advanced/metastatic disease 1) Prior adjuvant/neoadjuvant therapy is allowed if at least 6 months has elapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the study); 2) No previous targeted therapy; 3) For patients who can't tolerate first-line chemotherapy or refuse to accept chemotherapy, if they request to participate in this study, may receive apatinib monotherapy after consultation with the principal investigator in consideration of ethics.

6. Hematological, Biochemical and Organ Functions: HB = 80 g/L, ANC = 1.5×109/L, PLT = 80×109/L, BIL < 1.5×ULN, ALT or AST < 2.5×ULN (or < 5×ULN in patients with liver metastases), Serum Cr = 1×ULN, Cr clearance = 50 mL/min;

7. Life expectancy of more than 3 months;

8. Duration from operation is more than 4 weeks;

9. For women of child-bearing age, the pregnancy test results (serum or urine) within 7 days before enrolment must be negative. They will 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), will take appropriate methods for contraception during the study until the 8th week post the last administration of study drug.

10. Signed informed consent.

Exclusion Criteria:

1. Patients with poor-controlled arterial hypertension (systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mm Hg) despite standard medical management; Coronary heart disease, arrhythmia (including QT interval prolongation, for man > 450 ms, for woman > 470 ms), and cardiac dysfunction greater than Class II;

2. Factors affecting the oral medication, such as inability to swallow, chronic diarrhea and intestinal obstruction;

3. Patients with a clear tendency of gastrointestinal bleeding;

4. Abnormal coagulation function (INR > 1.5×ULN, APTT > 1.5×ULN), with tendency of bleed;

5. Pregnant or lactating women;

6. Other conditions regimented at investigators' discretion.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Apatinib
Apatinib (500 mg qd p.o.) until disease progression or intolerable toxicity
• S-1
S-1 (40 mg/m2 qd days 1-14 q3w p.o.) until disease progression or intolerable toxicity

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Qingdao Municipal Hospital	Jiangsu HengRui Medicine Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival		Event driven, an expected average of 8 months	No
Primary	Safety will be assessed by incidence of adverse events		An expected average of 8 months	Yes
Secondary	Objective response rate (ORR)		An expected average of 8 months	No
Secondary	Disease control rate (DCR)		An expected average of 8 months	No
Secondary	Overall survival (OS)		Event driven, an expected average of 24 months	No
Secondary	Quality of life (QoL)	Quality of life of patient will be measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 [EORTC QLQ-C30].	An expected average of 24 months	Yes