NCT03271073

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2 gastric-cancer

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
Last Updated

September 1, 2017

Status Verified

August 1, 2017

Enrollment Period

2.5 years

First QC Date

August 31, 2017

Last Update Submit

August 31, 2017

Conditions

Gastric Cancer

Keywords

gastric cancergastroesophageal junction cancerApatinibS1

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Overall survival (OS)

    Approximately 2 years

  • Safety (incidence of adverse events)

    Approximately 1 year

  • Quality of life(QoL)

    Approximately 2 years

Study Arms (1)

Apatinib plus S1

EXPERIMENTAL

patients with advanced gastric cancer enrolled after failure of first-line systemic chemotherapy will be given Apatinib plus S1 till progressive disease,death or non-tolerable toxicity

Drug: Apatinib

Interventions

ApatinibDRUG

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

Also known as: S1
Apatinib plus S1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients, aged between 18 and 75 years old;
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2;
  • 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;
  • Failure or intolerance to at least one prior line of systemic chemotherapy regimen;
  • 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);
  • Expected survival of ≥ 12 weeks.

You may not qualify if:

  • 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;
  • 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;
  • Abnormal Coagulation (INR\>1.5、APTT\>1.5 UNL), with tendency of bleed;
  • Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
  • Previous treatment with VEGFR inhibitor (i.e. Apatinib, sorafenib, sunitinib);
  • With psychotropic drug abuse history and can't get rid of or mental disorder patients;
  • Associated with CNS (central nervous system) metastases;
  • Active bacterial infections;
  • Pregnant or breast-feeding women;
  • Any other condition that might place the patient at undue risk or preclude a patient from completing the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Friendship Hospital

Beijing, Beijing Municipality, 100050, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

apatinibS 1 (combination)

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Wei Deng, M.D.

    Beijing Friendship Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Deng, M.D.

CONTACT

+8613426136152dengweiwei@126.com

Zhigang Bai, M.D.

CONTACT

+8613126617140bai_zhg@163.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
assistant dean, professor

Study Record Dates

First Submitted

August 31, 2017

First Posted

September 1, 2017

Study Start

February 1, 2016

Primary Completion

July 31, 2018

Study Completion

January 31, 2019

Last Updated

September 1, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)