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The purpose of this study is to determine whether apatinib plus irinotecan can improve progression free survival compared with single irinotecan in patients with advanced gastric cancer or adenocarcinoma of esophagogastric junction who failed one lines of chemotherapy.
Gastric cancer is the leading cause of cancer death in China. Most patients are unresectable or metastatic disease at the time of diagnosis,so the prognosis is poor.Systemic therapy was required for the patients with advanced stage. Platinum combined with fluoropyrimidines always were considered as first line treatment. After failure of initial therapy, single agent of irinotecan was used as second line treatment,but limited survival benefit.Apatinib, a novel targeted inhibitor of VEGF receptor 2 (VEGFR2).The purpose of this study is to determine whether apatinib plus irinotecan can improve progression free survival compared with single irinotecan in patients with advanced gastric cancer or adenocarcinoma of esophagogastric junction who failed one lines of chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Irinotecan plus apatinib | Experimental | Irinotecan:160mg/m2, ivgtt,given on the eighth day; Apatinib:initial dose:250mg,oral,once a day, after meal ( try to take the medicine at the same time of the dauntoy ). Repeat the therapeutic schedule every 2 weeks till progressive disease or intolerable toxicities. |
|
| Irinotecan | Active Comparator | Irinotecan:180mg/m2, ivgtt,given on the eighth day. Repeat the therapeutic schedule every 2 weeks till progressive disease or intolerable toxicities. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib | Drug | Apatinib, a novel targeted inhibitor of VEGF receptor 2 (VEGFR2). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | 18 months | |
| Adverse Event(AE) | NCI CTC 4.03 | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | 18 months | |
| Disease Control Rate (DCR) | 18 months | |
| Overall Survival(OS) |
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Inclusion Criteria:
Age:18~70years;
Subjects with Histologically or cytologically confirmed advanced gastric cancer or adenocarcinoma of esophagogastric junction ï¼›
Subjects must have received no more than one lines treatment before participating,and have received no irinotecan or antiangiogenic(including apatinib)treatment previously; Note:(1) Time of first-line treatment for subjects with advanced tumour must more than 1 cycles;(2) Adjuvant / neoadjuvant therapy was allowed; adjuvant / neoadjuvant therapy will be considered as a first-line treatment if disease recurrence during treatment or after less than 24 weeks.
subjects with at least one measurable lesion as defined by RECIST (version 1.1);Lesions previously treated with radiotherapy or locoregional therapy must show radiographic evidence of disease progression to be deemed a target lesion.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1ï¼›
Survival expectation≥ 3 months;
The interval of subjects had received cytotoxic drugs, radiotherapy or surgery must more than 4 weeks(besides nitroso or mitomycin must more than 6 weeks), and the wound has healed before participating;
No serious concomitant diseases(including heart,lung,liver jaundice or gastrointestinal obstruction and so on );
Adequate organ functions defined as indicated below: (1)Adequate bone marrow function, defined as: (no blood transfusion within 14 days)
Females of childbearing potential must be a pregnancy test in 7 days before participating ( including serum or urine), and the results were negative, Females of childbearing potential must agree to use a highly effective method of contraception throughout the entire study period and for 8 weeks after study drug discontinuation. Male subjects must have had a successful vasectomy or they and their female partners must meet the criteria above (i.e.not of childbearing potential or practicing highly effective contraception throughout the study period and for 8 weeks after study drug discontinuation).
Subjects provided written informed consent before participating,Willing and able to comply with all aspects of the protocol
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianwei Yang | Contact | 008613805097959 | swzcq62@163.com | |
| Sha Huang | Contact | 008613763820570 | huangsha0210@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianwei Yang | Fujian Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jianwei Yang | Fuzhou | Fujian | 350000 | China |
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| ID | Term |
|---|---|
| C553458 | apatinib |
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Irinotecan | Drug | Irinotecan was used as second line treatment with AGC. |
|
| 18 months |
| Quality of Life (QoL) | Use the validated European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 [EORTC QLQ-C30]. | 18 months |