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

Sponsor
Zhejiang Cancer Hospital
Study ID
NCT03276156
Phase
PHASE1
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apatinib plus S-1 — DRUG
    Drug:Apatinib (425 mg/d) + S-1 (80mg to 120 mg);Drug:Apatinib (500 mg/d) + S-1 (80mg to 120 mg);Drug:Apatinib (675mg/d) + S-1 (80mg to 120 mg);Drug:Apatinib (750 mg/d) + S-1 (80mg to 120 mg);

Study Details

The purpose of this study is to determine the maximum tolerated dose (MTD)and safety of Apatinib combined with S-1 as Second-line therapy for patients with advanced gastric or gastroesophageal junction adenocarcinoma.

Key Dates

Start date
Feb 23, 2016
Status verified
May 2017
Primary completion
Feb 22, 2018
Completion
Feb 22, 2018

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Apatinib plus S-1
    Apatinib (425/500/675/750mg,qd,p.o.) concomitantly with S-1 (80mg to 120 mg, qd,days1-14, q3w, p.o.)

Primary Outcome Measure

Progression Free Survival(PFS) [ Time Frame: Event driven, an expected average of 4 months ]

Central Contacts

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