NCT02529878

Brief Summary

The prognosis of metastatic gastric cancer is poor. Chemotherapy occasionally converts an initially unresectable gastric cancer to a resectable cancer. Previous studies showed patients with unresectable gastric cancer may obtain a survival benefit from chemotherapy and subsequent curative surgery. The key of conversion therapy of initially unresectable metastatic GC is the high response rate. Apatinib, a novel targeted inhibitor of VEGF receptor 2 (VEGFR2), shows significant antitumor activity in the patients with GC. The purpose of this study is to investigate the efficacy and safety of S1/Paclitaxel chemotherapy plus Apatinib in the conversion therapys of metastatic gastric cancer.

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
30

participants targeted

Target at below P25 for phase_2 gastric-cancer

Timeline
Completed

Started Aug 2015

Typical duration for phase_2 gastric-cancer

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

August 1, 2015

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

August 19, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 20, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

July 26, 2016

Status Verified

February 1, 2016

Enrollment Period

1 year

First QC Date

August 19, 2015

Last Update Submit

July 23, 2016

Conditions

Gastric Cancer

Keywords

gastric canerApatinibS1conversion therapymetastatic gastric cancer

Outcome Measures

Primary Outcomes (1)

  • radical resection rate

    the radical resection rates

    4 months

Secondary Outcomes (3)

  • overall survival

    3 years

  • adverse events

    6 months

  • reaction rate

    4 months

Study Arms (1)

conversion treatment

EXPERIMENTAL

after 3 cycles S1/Paclitaxel chemotherapy plus Apatinib,subsequent surgery will be conducted with curative intent

Drug: S1/Paclitaxel chemotherapy plus Apatinib

Interventions

S1/Paclitaxel chemotherapy plus ApatinibDRUG

S1:60mg twice daily(after the breakfast and supper) for two weeks, and then suspend for one week Paclitaxel:150mg/m2,iv, 3h, at day1 Apatinib:500mg once daily

Also known as: SPA
conversion treatment

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • unresectable gastric cancer as proven histologically(AJCC, version 7) under any following condition: unable radical excision due to the local metastasis of invasion metastasis to the lymph node beside the abdominal aorta, non-extensive metastasis to liver( not more than three metastatic foci of radical excision), Peritoneal metastasis(CY1,P1,P2), kukerburg tumor
  • Definitely diagnosed as above stage of gastric cancer before operation via CT of MRI, ultrasonic endoscopy, PET-CT, or through the laparoscopic exploration if necessary
  • Untreated(e.g. radiotherapy, chemotherapy, target therapy and immunotherapy)
  • Negative HER-2 state
  • ECOG(Eastern Cooperative Oncology Group) :0\~2
  • Age: 18\~75 years old
  • Normal hemodynamic indices before the recruitment(including blood cell count and liver/kidney function ). For example: WBC\>4.0\*109/L, NE\>1.5\*109/L, PLT\>100\*109/L, BIL\<1.5 times of upper limit of normal reference value, ALT and AST\<2.5 times of upper limit of normal reference value, and CRE\<1.2mg/dl
  • Good cardiac function before the recruitment, no seizure of myocardial infarction in past half years, and controllable hypertension and other coronary heart disease
  • Not concomitant with other uncontrollable benign disease before the recruitment(e.g. the infection in the kidney, lung and liver)
  • Not participating in other clinical trials before and during the treatment
  • Signed the Informed Consent Form

You may not qualify if:

  • Distal metastasis to lung, brain, and bone
  • Ever operation on the stomach
  • Operation intolerance due to other systemic basic disease
  • Ever administrated with other drugs(including TCM drugs) before the recruitment, or no guarantee of progress according to the study requirement after recruitment
  • Allergy to the drugs in this protocol
  • Pregnant and lactating women
  • Women at childbearing age and of pregnancy desire during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the First Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310006, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

apatinib

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Xiangdong Cheng, MD

    The First Affiliated Hospital of Zhejiang Chinese Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiangdong Cheng, MD

CONTACT

+86-057187070965getfar@foxmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2015

First Posted

August 20, 2015

Study Start

August 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2019

Last Updated

July 26, 2016

Record last verified: 2016-02

Locations

CN(1)