NCT03599778

Brief Summary

To observe and evaluate the efficacy and safety of oxaliplatin with oapecitabine（XELOX）combined with apatinib as post-operative chemotherapy in locally advanced gastric adenocarcinoma with D2 dissection

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
52

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2018

Longer than P75 for phase_1

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

June 14, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2025

Completed
Last Updated

July 26, 2018

Status Verified

July 1, 2018

Enrollment Period

6.4 years

First QC Date

June 14, 2018

Last Update Submit

July 24, 2018

Conditions

Gastric Carcinoma

Keywords

apatinibGastric Carcinomapost-operative chemotherapy

Outcome Measures

Primary Outcomes (1)

  • Disease-free survival (DFS)

    Disease-free survival (DFS) is defined as the time from the beginning of treatment to Disease recurrence or death due to Disease progression

    3 months

Study Arms (2)

treatment group

EXPERIMENTAL

8 cycles of postoperative XELOX regimen (capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w) + apatinib'MTD(maximum tolerated dose)

Drug: Apatinib

Control group

ACTIVE COMPARATOR

8 cycles of postoperative XELOX regimen (capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w)

Drug: Apatinib

Interventions

ApatinibDRUG

XELOX + apatinib's MTD

Also known as: XELOX
Control grouptreatment group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ECOG score is 0-1;
  • Radical gastrectomy (D2, R0) for gastric cancer has been performed (more than 16 lymph nodes have been detected);
  • Postoperative histology confirmed gastric adenocarcinoma；
  • The pathological stage of gastric cancer is ⅢA-ⅢC stage (8th AJCC TNM);
  • Subjects' baseline blood routine and biochemical indicators meet the following standards:
  • ANC≥1.5×109/L;
  • Hb≥90g/L;
  • PLT≥100×109/L;
  • TBIL≤1.5×ULN;
  • ALT and AST≤2×ULN;
  • Cr≤1.5×ULN
  • INR：1.0～1.5; APTT is within the normal range
  • The electrocardiogram was basically normal before the first 4 weeks after admission, and there were no obvious clinical symptoms of heart disease;
  • Sign informed consent.

You may not qualify if:

  • Patients with severe hypertension and poor drug control;
  • Various factors that affect oral drugs such as (inability to swallow, complete or incomplete gastrointestinal obstruction, active gastrointestinal bleeding, perforation ) ;
  • Patients with previous bradycardia or prolonged QT interval;
  • Patients with postoperative gastrointestinal fistula and wound rupture;
  • Known allergy to capecitabine or oxaliplatin, or metabolic disorder;
  • Patients receiving preoperative chemotherapy, radiotherapy or targeted therapy before;
  • Patients Using other experimental drugs at the same time or joining in other clinical trials.
  • Patients with severe liver diseases (such as liver cirrhosis), nephropathy, respiratory diseases or chronic systemic diseases such as uncontrollable diabetes and hypertension; Clinical symptoms of heart disease,such as congestive heart failure,coronary heart disease symptoms, arrhythmia, hypertension,that hard to control,or having myocardial infarction attack in six months or cardiac insufficiency.
  • Patients with peripheral nervous system disorder or with a history of significant psychiatric disorder and central nervous system disorder;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anhui Provincial Cancer Hospital

Hefei, Anhui, 230000, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

apatinibXELOX

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Xinyang He, master

    Anhui Provincial Cancer Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xinyang He, master

CONTACT

13505518319HXY2333@126.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2018

First Posted

July 26, 2018

Study Start

September 1, 2018

Primary Completion

January 30, 2025

Study Completion

January 30, 2025

Last Updated

July 26, 2018

Record last verified: 2018-07

Locations

CN(1)