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Trial record 80 of 6670 for:    Recruiting, Not yet recruiting, Available Studies | Digestion

The Maintenance Treatment of Apatinib/Capecitabine Versus Observation in Advanced Gastric Cancer

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ClinicalTrials.gov Identifier: NCT03889626
Recruitment Status : Not yet recruiting
First Posted : March 26, 2019
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Xiaodong Zhu, Fudan University

Brief Summary:
The purpose of this study is to evaluate the efficacy and tolerability of the maintenance treatment of Apatinib/Capecitabine after fluorouracil and platinum based first-line chemotherapy in advanced gastric cancer.

Condition or disease Intervention/treatment Phase
Stomach Neoplasms Gastrointestinal Neoplasms Stomach Diseases Digestive System Neoplasms Capecitabine Apatinib Neoplasms Molecular Mechanisms of Pharmacological Action Drug: Apatinib Drug: Capecitabine Phase 3

Detailed Description:
Up to now, whether maintenance therapy after first line treatment can bring survival benefits to patients with advanced gastric cancer is unknown, and let alone which drug is most suitable. Our study is designed to prove whether the maintenance treatment of Apatinib or Capecitabine are better than observation after fluorouracil/platinum based first-line chemotherapy in advanced gastric cancer

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 242 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Study of Comparing the Maintenance Treatment of Apatinib, Capecitabine and Observation After First-line Therapy in Advanced Gastric Cancer
Estimated Study Start Date : March 22, 2019
Estimated Primary Completion Date : March 22, 2022
Estimated Study Completion Date : March 22, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: Apatinib
In this arm, patients will receive a daily oral treatment with Apatinib 500mg.
Drug: Apatinib
Apatinib: 500mg qd po, q4w

Experimental: Capecitabine
In this arm , patients will receive capecitabine 1000mg/m2 twice for 14 days, and repeat every 3 weeks.
Drug: Capecitabine
Capecitabine: 1000mg/m2 bid po, d1-14, q3w

No Intervention: Observation
In this arm, no additional treatment will be given, and patients will be followed up at regular time



Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: six weeks ]
    PFS is calculated from the time of randmization to disease progression or death whichever happen first


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: six weeks ]
    OS is calculated from the time of randmization to death


Other Outcome Measures:
  1. Quality of Life (QoL) [ Time Frame: six weeks ]
    we will use EORTC QLQ-C30 to evaluate QoL.

  2. Adverse Events [ Time Frame: six weeks ]
    we will use CTC AE4.0 to evaluate adverse events.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   no younger than 18 year-old
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed advanced or metastatic gastric or gastroesophageal junction adenocarcinoma
  • ECOG PS 0-2
  • At least one measurable or evaluable lesion in the first-line chemotherapy
  • The fist line treatment should be 5-FU based regimen (e.g. ECF/EOF/EOX/FOLFOX/XELOX/XP) , and patients should received 6 cycles (3-week regimen) or 12 cycles (2-week regimen) treatment with the efficacy of non-PD
  • The time from the last cycle treatment to the enrollment cannot exceed 6 weeks
  • Adequate hepatic, renal, heart, and hematologic functions (platelets ≥75×109/L, neutrophil ≥1.5×109/L, hemoglobin ≥80 g/L, serum creatinine ≤1.5mg/dl, total bilirubin ≤1.5mg/dl, and serum transaminase ≤2.5× the ULN)

Exclusion Criteria:

  • Received 2 or more regimens for palliative chemotherapy
  • Pregnant or lactating women
  • Concurrent cancer, or history of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
  • Uncontrolled brain, or leptomeningeal involvement, complete intestinal obstruction
  • Clinically significant active bleeding, OB 2+ or higher
  • Patients with locally advanced gastric cancer who are scheduled to receive radiotherapy
  • Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months or high risk/uncontrolled arrhythmia
  • Uncontrolled significant comorbid conditions

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Responsible Party: Xiaodong Zhu, Principal Investigator and Clinical Professor, Fudan University
ClinicalTrials.gov Identifier: NCT03889626     History of Changes
Other Study ID Numbers: Apa/Cap maintenance in GC
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Xiaodong Zhu, Fudan University:
Capecitabine
Apatinib
Maintenance Treatment
Advance Gastric Cancer
Additional relevant MeSH terms:
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Digestive System Neoplasms
Digestive System Diseases
Stomach Neoplasms
Gastrointestinal Neoplasms
Stomach Diseases
Neoplasms
Neoplasms by Site
Gastrointestinal Diseases
Capecitabine
Apatinib
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors