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Evaluate the Efficacy of Maintenance Treatment With Capecitabine Plus Apatinib in Advanced Gastric Cancer

Primary Purpose

Gastric Cancer

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Apatinib+Capecitabine
Apatinib
Sponsored by
Huazhong University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring advanced gastric cancer, apatinib, capecitabine, maintenance

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. aged 18-75；
  2. had histologically confirmed unresectable and/or metastatic (primary or recurrent) adenocarcinoma of the stomach or gastroesophageal junction；
  3. received 4-6 cycles of Xelox/SOX regimens as first-line chemotherapy and the response was not progression disease (PD);
  4. ECOG 0-2；
  5. Patients were tested for tumor HER2 status before treatment, and patients with HER2-negative disease；
  6. presence of at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines；
  7. Subjects has to voluntarily join the study and sign the Informed Consent Form for the study;
  8. 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
  9. Receiving no form of chemotherapy, targeted therapy or other study medication;

Exclusion Criteria:

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

Sites / Locations

  • Huazhong University of Science and TechnologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Experimental

Arm Label

Maintenance Treatment Group A

Observation Group

Maintenance Treatment Group B

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

OS
From date of randomization until the date of first documented death from any cause, assessed up to 36 months

Full Information

First Posted
December 24, 2017
Last Updated
July 15, 2018
Sponsor
Huazhong University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT03598348
Brief Title
Evaluate the Efficacy of Maintenance Treatment With Capecitabine Plus Apatinib in Advanced Gastric Cancer
Official Title
Maintenance Treatment With Capecitabine Plus Apatinib vs. Apatinib and Observation After First-line XELOX/SOX Chemotherapy for Patients With Advanced Gastric Cancer: a Multicenter, Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 16, 2018 (Actual)
Primary Completion Date
January 16, 2020 (Anticipated)
Study Completion Date
October 16, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huazhong University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
advanced gastric cancer, apatinib, capecitabine, maintenance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
288 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Maintenance Treatment Group A
Arm Type
Experimental
Arm Description
Maintenance Treatment with Capecitabine plus Apatinib after First-line XELOX chemotherapy for Patients with Advanced Gastric Cancer
Arm Title
Observation Group
Arm Type
No Intervention
Arm Description
Observation after First-line XELOX chemotherapy for Patients with Advanced Gastric Cancer
Arm Title
Maintenance Treatment Group B
Arm Type
Experimental
Arm Description
Maintenance Treatment with Apatinib after First-line XELOX chemotherapy for Patients with Advanced Gastric Cancer
Intervention Type
Drug
Intervention Name(s)
Apatinib+Capecitabine
Other Intervention Name(s)
apatinib, capecitabine
Intervention Description
Capecitabine 1000mg/m2 po bid, d1-14, Apatinib 250mg po Qd, Q21d
Intervention Type
Drug
Intervention Name(s)
Apatinib
Intervention Description
Apatinib 250mg po Qd
Primary Outcome Measure Information:
Title
PFS
Description
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
Time Frame
36 months
Secondary Outcome Measure Information:
Title
OS
Description
From date of randomization until the date of first documented death from any cause, assessed up to 36 months
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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; Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xianglin Yuan, PhD,MD
Phone
8627-83663406
Email
xlyuan1020@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ping Peng, PhD,MD
Phone
8627-83663407
Email
pengpingtj@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xianglin Yuan, PhD,MD
Organizational Affiliation
Tongji Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xianglin Yuan, PhD,MD
Phone
8627-83663406
Email
xlyuan1020@163.com
First Name & Middle Initial & Last Name & Degree
Ping Peng, PhD,MD
Phone
8627-83663407
Email
pengpingtj@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Evaluate the Efficacy of Maintenance Treatment With Capecitabine Plus Apatinib in Advanced Gastric Cancer

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