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

NCT02525237 | Unknown Phase 2

• 1 other identifier: Ahead-G316
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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)

  An expected average of 24 months

Study Arms (1)

Apatinib plus S-1

EXPERIMENTAL

Apatinib (500 mg qd p.o.) concomitantly with S-1 (40 mg/m2 qd days 1-14 q3w p.o.)

Drug: Apatinib; Drug: S-1

Interventions

Apatinib DRUG

Apatinib (500 mg qd p.o.) until disease progression or intolerable toxicity

Also known as: ATAN

Apatinib plus S-1

S-1 DRUG

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

Apatinib plus S-1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients, aged ≥18 years;
• Histologically confirmed adenocarcinoma of the stomach with inoperable locally advanced or recurrent and/or metastatic disease;
• Measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1);
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 3;
• 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.
• 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;
• Life expectancy of more than 3 months;
• Duration from operation is more than 4 weeks;
• 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.
• Signed informed consent.

You may not qualify if:

• 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;
• Factors affecting the oral medication, such as inability to swallow, chronic diarrhea and intestinal obstruction;
• Patients with a clear tendency of gastrointestinal bleeding;
• Abnormal coagulation function (INR \> 1.5×ULN, APTT \> 1.5×ULN), with tendency of bleed;
• Pregnant or lactating women;
• Other conditions regimented at investigators' discretion.

Sponsors & Collaborators

• Qingdao Municipal Hospital: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

apatinib; S 1 (combination)

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Xiaochun Zhang, MD, PhD

CONTACT

+86 0532 88905767; zxc96701@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman

Study Record Dates

• First Submitted: August 11, 2015
• First Posted: August 17, 2015
• Study Start: August 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2017
• Last Updated: August 17, 2015

Record last verified: 2015-08