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

Neoplasms Clinical Trial

Official title:

A Phase III Study of Comparing the Maintenance Treatment of Apatinib, Capecitabine and Observation After First-line Therapy in Advanced Gastric Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03889626
• Other study ID #: Apa/Cap maintenance in GC
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: March 22, 2019
• Est. completion date: March 22, 2024

Study information

• Verified date: March 2019
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 242
• Est. completion date: March 22, 2024
• Est. primary completion date: March 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Apatinib
• Capecitabine
• Digestive System Neoplasms
• Gastrointestinal Neoplasms
• Molecular Mechanisms of Pharmacological Action
• Neoplasms
• Stomach Diseases
• Stomach Neoplasms

Intervention

Drug:
• Apatinib
Apatinib: 500mg qd po, q4w
• Capecitabine
Capecitabine: 1000mg/m2 bid po, d1-14, q3w

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of Life (QoL)	we will use EORTC QLQ-C30 to evaluate QoL.	six weeks
Other	Adverse Events	we will use CTC AE4.0 to evaluate adverse events.	six weeks
Primary	Progression Free Survival (PFS)	PFS is calculated from the time of randmization to disease progression or death whichever happen first	six weeks
Secondary	Overall Survival (OS)	OS is calculated from the time of randmization to death	six weeks