XELOX Combined With Apatinib as Post-operative Chemotherapy in Locally Advanced Gastric Adenocarcinoma

July 24, 2018 updated by: Anhui Provincial Hospital

A Phase I/II Clinical Study to Compare Postoperative Chemotherapy of Oxaliplatin With Capecitabine（XELOX）Combined With APATINIB as Post-operative Chemotherapy in Locally Advanced Gastric Adenocarcinoma With D2 Dissection

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Stage 1 (phase I tolerance study) : 12 patients were enrolled in the dose-climbing study:According to the principle of dose-climbing test,todetermine the subjects' MTD, with the following three dose levels:

  • Capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w) + apatinib 250 mg, qd x180d; ②. Capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w) + apatinib 375 mg, qd x180d; ③. Capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w) + apatinib 500 mg, qd x180d;

Stage 2 (phase II exploratory study) :

①.Test group: subjects received 8 cycles of postoperative XELOX regimen (capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w) + apatinib maximum tolerated dose

②.Control group: Subjects received 8 cycles of XELOX regimen after surgery (capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w).

Eligible patients will receive 8 cycles of postoperative adjuvant therapy and will be followed up to death

Study Type

Interventional

Enrollment (Anticipated)

52

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Xinyang He, master
  • Phone Number: 13505518319
  • Email: HXY2333@126.com

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230000
        • Anhui Provincial Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. ECOG score is 0-1;
  2. Radical gastrectomy (D2, R0) for gastric cancer has been performed (more than 16 lymph nodes have been detected);
  3. Postoperative histology confirmed gastric adenocarcinoma；
  4. The pathological stage of gastric cancer is ⅢA-ⅢC stage (8th AJCC TNM);

  5. 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
  6. The electrocardiogram was basically normal before the first 4 weeks after admission, and there were no obvious clinical symptoms of heart disease;
  7. Sign informed consent.

Exclusion Criteria:

  1. Patients with severe hypertension and poor drug control;
  2. Various factors that affect oral drugs such as (inability to swallow, complete or incomplete gastrointestinal obstruction, active gastrointestinal bleeding, perforation ) ;
  3. Patients with previous bradycardia or prolonged QT interval;
  4. Patients with postoperative gastrointestinal fistula and wound rupture;
  5. Known allergy to capecitabine or oxaliplatin, or metabolic disorder;
  6. Patients receiving preoperative chemotherapy, radiotherapy or targeted therapy before;
  7. Patients Using other experimental drugs at the same time or joining in other clinical trials.
  8. 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.
  9. Patients with peripheral nervous system disorder or with a history of significant psychiatric disorder and central nervous system disorder;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: treatment group
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
XELOX + apatinib's MTD
Other Names:
  • XELOX
ACTIVE_COMPARATOR: Control group
8 cycles of postoperative XELOX regimen (capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w)
Drug: Apatinib
XELOX + apatinib's MTD
Other Names:
  • XELOX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival (DFS)
Time Frame: 3 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anhui Provincial Hospital

Investigators

  • Principal Investigator: Xinyang He, master, Anhui Provincial Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2018

Primary Completion (ANTICIPATED)

January 30, 2025

Study Completion (ANTICIPATED)

January 30, 2025

Study Registration Dates

First Submitted

June 14, 2018

First Submitted That Met QC Criteria

July 24, 2018

First Posted (ACTUAL)

July 26, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 26, 2018

Last Update Submitted That Met QC Criteria

July 24, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AHTH-201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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