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A Clinical Trial of Maintenance Treatment of Apatinib in Advanced Gastric Cancer Patients Have Completed Postoprative Adjuvant Chemotherapy

Primary Purpose

Gastric Cancer

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Apatinib Mesylate Tablets
Sponsored by
Tianjin Medical University Cancer Institute and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Gastric cancer, D2 Lymphadenectomy, postoprative adjuvant chemotherapy, Apatinib, disease free survival

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age of patients ranges from 18 to75 years old.
  2. Score of the Eastern Cooperative Oncology Group (ECOG) performance status ranges from 0 to 2.
  3. All tumor tissues were histologically verified as advanced gastric cancer, and patients with no less than 15 dissected lymph nodes and stage of ⅢB or ⅢC according to TNM, were chosen.
  4. Gastric cancer patients underwent the curative gastrectomy with D2 lymphadenectomy.
  5. Gastric cancer patients received postoprative adjuvant chemotherapy of eight cycles of Xelox. During the period of chemotherapy, no one relapses. If the patients could well tolerate the adjuvant chemotherapy, it is recommended that patients can obtain maintenance treatment of Apatinib after postoprative adjuvant chemotherapy of eight cycles of Xelox.
  6. Previously, patients did not receive the therapy of Apatinib or other VEGFR inhibitor, such as Sorafenib, Sunitinib.
  7. The blood examination is normal: neutrophil count≥1.5×109/L；hemoglobin≥80 g/L；blood platelet count≥100×109/L；total bilirubin≤1.5×ULN；ALT、AST≤2.5×ULN；

  8. Patients have no serious heart, lung, liver, kidney diseases and jaundice and digestive tract obstruction. Patients have no an acute infection.

    -

Exclusion Criteria:

  1. The score of KPS<60 or anticipated survival time<3 months.
  2. Previously, patients received neoadjuvant chemotherapy.
  3. Within six months, patients encountered heart cerebral disease, got an uncontrolled hypertension (systolic blood pressure>140 mmHg, diastolic blood pressure>90 mmHg), had serious coronary heart disease, serious arrhythmia, first-grade cardiac insufficiency. Patients have positive urinary protein.
  4. Patients have clear gastrointestinal bleeding tendency, local active ulcer lesions, fecal occult blood (++); Patients have the symptoms of melena and haematemesis within 2 months.
  5. Coagulopathy (INR>1.5、APTT>1.5 ULN), hemorrhage tendency.
  6. Patients have these symptoms, such as dysphagia, nausea, vomiting, chronic diarrhea and intestinal obstruction.
  7. Patients have these symptoms, such as neurological diseases, mental illness, serious infection.
  8. Patients were pregnant, in nursing, or have bearing requirement during the study period.
  9. Patients got other primary malignant tumors (except curable skin basal cell carcinoma and cervical cancer in situ) except gastric cancer within 5 years.
  10. Patients have distant metastasis.

  11. Within 6 months before study starts and in the process of this study, patients participate in other clinical researches.

    -

Sites / Locations

  • Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

A group

B group

Arm Description

D2 Radical Gastrectomy adding received postoprative adjuvant chemotherapy of eight cycles of Xelox,and taking Apatinib 500mg/qd orally, 28 days as a cycle, till disease progresses.

D2 Radical Gastrectomy adding received postoprative adjuvant chemotherapy of eight cycles of Xelox

Outcomes

Primary Outcome Measures

disease free survival
Disease free survival (DFS) was defined as the length of time from the date of randomization to the date of first documentation of relapse of gastric cancer or any other type of cancer or death.

Secondary Outcome Measures

overall survival
Overall survival (OS) was defined as the length of time from the date of randomization to the date of death of various reasons

Full Information

First Posted
May 15, 2016
Last Updated
May 19, 2016
Sponsor
Tianjin Medical University Cancer Institute and Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02776527
Brief Title
A Clinical Trial of Maintenance Treatment of Apatinib in Advanced Gastric Cancer Patients Have Completed Postoprative Adjuvant Chemotherapy
Official Title
A Clinical Trial of Maintenance Treatment of Apatinib in Advanced Gastric Cancer Patients Have Completed Postoprative Adjuvant Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
April 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The main purpose of this study is to evaluate whether the Apatinib can improve the disease free survival (DFS) of gastric cancer patients in stage IIIB/IIIc, who had completed postoprative adjuvant chemotherapy. Meanwhile, the investigators also will evaluate whether the Apatinib can improve the overall survival (OS), estimate the quality of life of patients have taken the Apatinib and monitor the security of Apatinib.
Detailed Description
The investigators will recruit 40 gastric cancer patients who underwent D2 lymphadenectomy and histologically verified as stage ⅢB or ⅢC according to the seventh edition of the TNM classification for gastric cancer. When these patients have completed 8 cycles of Xelox as adjuvant chemotherapy without any recurrence, they will randomly assigned to group A or B. Each group possesses 20 gastric cancer patients finally. Patients in group A will receive the best supportive care，and take Apatinib 500mg/qd orally, 28 days as a cycle, till disease progresses. Patients in group B will receive the best supportive care. Through follow-up and statistics, the investigators will observe whether Apatinib can improve the disease free survival (DFS) of gastric cancer patients with stage IIIb&IIIC. Meanwhile, the investigators also will observe whether the Apatinib can improve the overall survival (OS) and estimate the quality of life of patients have taken the Apatinib.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Gastric cancer, D2 Lymphadenectomy, postoprative adjuvant chemotherapy, Apatinib, disease free survival

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A group
Arm Type
Experimental
Arm Description
D2 Radical Gastrectomy adding received postoprative adjuvant chemotherapy of eight cycles of Xelox,and taking Apatinib 500mg/qd orally, 28 days as a cycle, till disease progresses.
Arm Title
B group
Arm Type
No Intervention
Arm Description
D2 Radical Gastrectomy adding received postoprative adjuvant chemotherapy of eight cycles of Xelox
Intervention Type
Drug
Intervention Name(s)
Apatinib Mesylate Tablets
Other Intervention Name(s)
AiTan
Intervention Description
taking Apatinib Mesylate Tablets 500mg/qd orally, 28 days as a cycle, till disease progresses
Primary Outcome Measure Information:
Title
disease free survival
Description
Disease free survival (DFS) was defined as the length of time from the date of randomization to the date of first documentation of relapse of gastric cancer or any other type of cancer or death.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
overall survival
Description
Overall survival (OS) was defined as the length of time from the date of randomization to the date of death of various reasons
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age of patients ranges from 18 to75 years old. Score of the Eastern Cooperative Oncology Group (ECOG) performance status ranges from 0 to 2. All tumor tissues were histologically verified as advanced gastric cancer, and patients with no less than 15 dissected lymph nodes and stage of ⅢB or ⅢC according to TNM, were chosen. Gastric cancer patients underwent the curative gastrectomy with D2 lymphadenectomy. Gastric cancer patients received postoprative adjuvant chemotherapy of eight cycles of Xelox. During the period of chemotherapy, no one relapses. If the patients could well tolerate the adjuvant chemotherapy, it is recommended that patients can obtain maintenance treatment of Apatinib after postoprative adjuvant chemotherapy of eight cycles of Xelox. Previously, patients did not receive the therapy of Apatinib or other VEGFR inhibitor, such as Sorafenib, Sunitinib. The blood examination is normal: neutrophil count≥1.5×109/L；hemoglobin≥80 g/L；blood platelet count≥100×109/L；total bilirubin≤1.5×ULN；ALT、AST≤2.5×ULN； Patients have no serious heart, lung, liver, kidney diseases and jaundice and digestive tract obstruction. Patients have no an acute infection. - Exclusion Criteria: The score of KPS<60 or anticipated survival time<3 months. Previously, patients received neoadjuvant chemotherapy. Within six months, patients encountered heart cerebral disease, got an uncontrolled hypertension (systolic blood pressure>140 mmHg, diastolic blood pressure>90 mmHg), had serious coronary heart disease, serious arrhythmia, first-grade cardiac insufficiency. Patients have positive urinary protein. Patients have clear gastrointestinal bleeding tendency, local active ulcer lesions, fecal occult blood (++); Patients have the symptoms of melena and haematemesis within 2 months. Coagulopathy (INR>1.5、APTT>1.5 ULN), hemorrhage tendency. Patients have these symptoms, such as dysphagia, nausea, vomiting, chronic diarrhea and intestinal obstruction. Patients have these symptoms, such as neurological diseases, mental illness, serious infection. Patients were pregnant, in nursing, or have bearing requirement during the study period. Patients got other primary malignant tumors (except curable skin basal cell carcinoma and cervical cancer in situ) except gastric cancer within 5 years. Patients have distant metastasis. Within 6 months before study starts and in the process of this study, patients participate in other clinical researches. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Han Liang, Master
Phone
086-022-23340123
Ext
1061
Email
tjlianghan@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Han Liang, Master
Organizational Affiliation
Tianjin Medical University Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liang Han, Master
Phone
086-022-23340123
Ext
1061
Email
tjlianghan@126.com

12. IPD Sharing Statement

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A Clinical Trial of Maintenance Treatment of Apatinib in Advanced Gastric Cancer Patients Have Completed Postoprative Adjuvant Chemotherapy

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