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Status unknownNCT02776527Updated May 20, 2016

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

A Phase 4 interventional study of Apatinib Mesylate Tablets in Gastric Cancer, sponsored by Tianjin Medical University Cancer Institute and Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-05-20.

Sponsored by Tianjin Medical University Cancer Institute and Hospital · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Gastric Cancer

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Keywords

  • Gastric cancer
  • D2 Lymphadenectomy
  • postoprative adjuvant chemotherapy
  • Apatinib
  • disease free survival
03

In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's planned enrollment of 40 is below the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital is the lead sponsor of 484 studies on the registry; 286 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

-

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.

    -

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    A group

    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.

    Drug: Apatinib Mesylate Tablets

  • No intervention
    B group

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

Interventions

  • DrugApatinib Mesylate Tablets

    taking Apatinib Mesylate Tablets 500mg/qd orally, 28 days as a cycle, till disease progresses

    Also known as: AiTan

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 years

Secondary outcomes

  1. 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

    Time frame: 3 years

07

Study locations

1 of 1 sites recruiting
  • Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Hospital
    Tianjin, Tianjin 300060, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02776527
Lead sponsor
Tianjin Medical University Cancer Institute and Hospital
Responsible party
Sponsor
First posted
May 18, 2016
Start date
Apr 2016
Primary completion
Apr 2017 (estimated)
Completion
Apr 2017 (estimated)
Last update
May 20, 2016

Study contacts

Han Liang, Master
Contact
tjlianghan@126.com
086-022-23340123 ext. 1061
Han Liang, Master
principal investigator · Tianjin Medical University Cancer Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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