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

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

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.

Study Overview

• Status: Unknown
• Conditions: Gastric Cancer
• Intervention / Treatment: Drug: Apatinib; Drug: S-1

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Apatinib plus S-1; Apatinib (500 mg qd p.o.) concomitantly with S-1 (40 mg/m2 qd days 1-14 q3w p.o.)	Drug: Apatinib; Apatinib (500 mg qd p.o.) until disease progression or intolerable toxicity; Other Names: ATAN; Drug: S-1; S-1 (40 mg/m2 qd days 1-14 q3w p.o.) until disease progression or intolerable toxicity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression Free Survival	Event driven, an expected average of 8 months
Safety will be assessed by incidence of adverse events	An expected average of 8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR)		An expected average of 8 months
Disease control rate (DCR)		An expected average of 8 months
Overall survival (OS)		Event driven, an expected average of 24 months
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

Collaborators and Investigators

• Sponsor: Qingdao Municipal Hospital
• Collaborators: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Anticipated): August 1, 2016
• Study Completion (Anticipated): August 1, 2017

Study Registration Dates

• First Submitted: August 11, 2015
• First Submitted That Met QC Criteria: August 14, 2015
• First Posted (Estimate): August 17, 2015

Study Record Updates

• Last Update Posted (Estimate): August 17, 2015
• Last Update Submitted That Met QC Criteria: August 14, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Apatinib
• Other Study ID Numbers: Ahead-G316