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

NCT02776527 | Unknown Phase 4 DMC

• 1 other identifier: AHEAD-HBG001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer

Keywords

Gastric cancer; D2 Lymphadenectomy; postoprative adjuvant chemotherapy; Apatinib; disease free survival

Outcome Measures

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.

  2 years

Secondary Outcomes (1)

• overall survival

  3 years

Study Arms (2)

A group

EXPERIMENTAL

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

B group

NO INTERVENTION

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

Interventions

Apatinib Mesylate Tablets DRUG

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

Also known as: AiTan

A group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

apatinib

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Han Liang, Master

  Tianjin Medical University Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Han Liang, Master

CONTACT

086-022-23340123; tjlianghan@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2016
• First Posted: May 18, 2016
• Study Start: April 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: May 20, 2016

Record last verified: 2016-04

Locations

CN (1)