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The tolerability of apatinib, an effective antiangiogenic agent, varies greatly in patients with stage IV cancer during treatment. This study will include patients with advanced (stage IV) gastric cancer, non-small-cell lung cancer (NSCLC), breast cancer or ovarian cancer, who will be administered apatinib treatment starting from 250 mg Qd and closely monitored for ADRs during the period of apatinib treatment. Meanwhile, relevant assay technologies will be used to precisely detect changes of various biomarkers in the patients treated by apatinib, with the aim of identifying biomarkers related to their prognosis and relevant complications so as to screen out the favored population, establish the drug's indication(s) and reduce relevant side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single group | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| apatinib | Drug | Patients with advanced (stage IV) gastric cancer, non-small-cell lung cancer (NSCLC), breast cancer or ovarian cancer will be included in this study to receive apatinib treaetment starting from 250 mg Qd and closely monitored for ADRs during apatinib treatment, with dosage adjustment performed as needed to make the treatment tolerable to the patients. |
| Measure | Description | Time Frame |
|---|---|---|
| metastasis | The patient was diagnosed as recurrence or metastasis according to the computed tomography (CT) scan | eight weeks |
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Inclusion Criteria:
Age of 18 and over, male or female;
Patients with histologically confirmed advanced (stage IV) gastric cancer, NSCLC, breast cancer or ovarian cancer, who choose monotherapy of oral vascular targeting drug (apatinib) due to intolerability or inappropriateness of other therapies;
Presence of measurable lesions (≥10mm on spiral CT scan) subject to RECIST 1.1;
Blood pressured controlled at 150/100 mHg following drug administration;
An ECOG PS score of between 0 and 1;
Findings of hematology and laboratory tests at the baseline that meet the following criteria:
Hemoglobin ≥80g/L; Absolute neutrophil count (ANC) ≥1.5×10^9/L; Platelets ≥90×10^9/L; ALT/AST ≤ 2.5×ULN; or ALT/AST ≤ 5×ULN for patients with hepatic metastases; Serum total bilirubin ≤1.5×ULN; Serum urea nitrogen and creatinine ≤ 1.5×ULN; Serum albumin ≥30g/L; Coagulation function (INR≤1.5, APTT≤1.5 ULN);
A life expectancy of at least 3 months;
Subjects who volunteer to participate in this study and have signed the Informed Consent Form (ICF), with good compliance with treatment and follow-up.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hao Long, Prof | Contact | +86 2087343261 | longhao@sysucc.org.cn | |
| Ruping Xing | Contact | +86 2087343736 | xingrp@sysucc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
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| ID | Term |
|---|---|
| C553458 | apatinib |
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|
| D005831 |
| Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |