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
Information provided by (Responsible Party):
Xiaodong Zhu, Fudan University
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|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||242 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
In this arm, patients will receive a daily oral treatment with Apatinib 500mg.
Apatinib: 500mg qd po, q4w
In this arm , patients will receive capecitabine 1000mg/m2 twice for 14 days, and repeat every 3 weeks.
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 :
- 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 :
- Overall Survival (OS) [ Time Frame: six weeks ]OS is calculated from the time of randmization to death
Other Outcome Measures:
- Quality of Life (QoL) [ Time Frame: six weeks ]we will use EORTC QLQ-C30 to evaluate QoL.
- Adverse Events [ Time Frame: six weeks ]we will use CTC AE4.0 to evaluate adverse events.
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