NCT03598348

Brief Summary

This is a multicenter, randomized, controlled trial to evaluate the efficacy and safety of Maintenance Treatment with Capecitabine plus Apatinib, Apatinib and Observation after First-line XELOX/SOX chemotherapy for Patients with Advanced 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
288

participants targeted

Target at P25-P50 for phase_3 gastric-cancer

Timeline
Completed

Started Jan 2018

Shorter than P25 for phase_3 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

First Submitted

Initial submission to the registry

December 24, 2017

Completed
23 days until next milestone

Study Start

First participant enrolled

January 16, 2018

Completed
6 months until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2020

Completed
Last Updated

July 26, 2018

Status Verified

July 1, 2018

Enrollment Period

2 years

First QC Date

December 24, 2017

Last Update Submit

July 15, 2018

Conditions

Gastric Cancer

Keywords

advanced gastric cancer, apatinib, capecitabine, maintenance

Outcome Measures

Primary Outcomes (1)

  • PFS

    From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

    36 months

Secondary Outcomes (1)

  • OS

    36 months

Study Arms (3)

Maintenance Treatment Group A

EXPERIMENTAL

Maintenance Treatment with Capecitabine plus Apatinib after First-line XELOX chemotherapy for Patients with Advanced Gastric Cancer

Drug: Apatinib+Capecitabine

Observation Group

NO INTERVENTION

Observation after First-line XELOX chemotherapy for Patients with Advanced Gastric Cancer

Maintenance Treatment Group B

EXPERIMENTAL

Maintenance Treatment with Apatinib after First-line XELOX chemotherapy for Patients with Advanced Gastric Cancer

Drug: Apatinib

Interventions

Apatinib+CapecitabineDRUG

Capecitabine 1000mg/m2 po bid, d1-14, Apatinib 250mg po Qd, Q21d

Also known as: apatinib, capecitabine
Maintenance Treatment Group A
ApatinibDRUG

Apatinib 250mg po Qd

Maintenance Treatment Group B

Eligibility Criteria

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

You may qualify if:

  • aged 18-75；
  • had histologically confirmed unresectable and/or metastatic (primary or recurrent) adenocarcinoma of the stomach or gastroesophageal junction；
  • received 4-6 cycles of Xelox/SOX regimens as first-line chemotherapy and the response was not progression disease (PD);
  • ECOG 0-2；
  • Patients were tested for tumor HER2 status before treatment, and patients with HER2-negative disease；
  • presence of at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines；
  • Subjects has to voluntarily join the study and sign the Informed Consent Form for the study;
  • Adequate organ function as defined below: Hematologic ANC ≥ 2\*109/L, Platelets ≥ 100\*109/L, AST and ALT ≤ 2.5×ULN, TBIL ≤ 1.5×ULN
  • Receiving no form of chemotherapy, targeted therapy or other study medication;

You may not qualify if:

  • previous radiotherapy to the abdomen；
  • previous treatment for advanced disease (neoadjuvant chemotherapy was permitted if administered \>6 months before enrollment)；
  • pregnant or lactating women or women of childbearing potential；
  • disease progression during the first-line chemotherapy;
  • active gastrointestinal bleeding, arterial thrombosis or cerebrovascular accident within 6 months before enrollment
  • previous treatment of apatinib and Ramucirumab

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

apatinibCapecitabine

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Xianglin Yuan, PhD,MD

    Tongji Hospital

    STUDY CHAIR

Central Study Contacts

Xianglin Yuan, PhD,MD

CONTACT

8627-83663406xlyuan1020@163.com

Ping Peng, PhD,MD

CONTACT

8627-83663407pengpingtj@163.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Chief physician

Study Record Dates

First Submitted

December 24, 2017

First Posted

July 26, 2018

Study Start

January 16, 2018

Primary Completion

January 16, 2020

Study Completion

October 16, 2020

Last Updated

July 26, 2018

Record last verified: 2018-07

Locations

CN(1)