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To control apatinib and capecitabine combination to maintain treating metastatic colorectal cancer.
To control apatinib and capecitabine combination to maintain treating metastatic colorectal cancer,primary endpoint include in mPFS; secondary endpoint include in mOS, tolerance and security.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: "apatinib" and "capecitabine" | Experimental | Arm A: "apatinib" and "capecitabine" apatinib 250mg qdpo; capecitabine 1000mg/m2 qdpo d1-14 q3w |
|
| B: "capecitabine" single drug | Active Comparator | Arm B: "capecitabine" single drug "capecitabine" 1000mg/m2 qdpo d1-14 q3w |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "Apatinib" and "Capecitabine" | Drug | Combine "Apatinib" and "Capecitabine" to Maintain Treating Metastatic Colorectal Cancer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival of Patients with Apatinib and Capecitabine Combination That is prolonged | Patients with double drug group have more longer progression-free survival (PFS) than patients with single drug group | up to 10 months |
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Inclusion Criteria:
Informed consent form should be issued prior to conducting any research process;
Men or women aged 18-75 years;
Patients with advanced and / or metastatic colorectal cancer confirmed by histology or cytology;
Patients who has not exposed to apatinib previously and had received oxaliplatin combined with fluorouracil chemotherapy;
The estimated survival time is longer than 3 months;
ECOG score was 0 or 1;
According to the RECIST v1.1 guidance, at least 1 lesion(who had not received radiotherapy) showed that the longest diameter≥10mm(except for lymph node, the short axis of the lymph node must be≥15mm) through CT or MRI(intravenous contrast agent was preferred ) accurate measurement and the lesion should be suitable for repeatable and accurate measurement; the lesion located in the previously irradiated area can be used as a measurable lesion if the lesion was proved in progress;
With sufficient organ and bone marrow function, defined as follows:
Women of childbearing age must have a pregnancy test (serum or urine) within 7 days before inclusion, the results should be negative and they are willing to use the appropriate methods of contraception during the trial and within 6 months of the last experimental drug administration. Men should agree to use appropriate methods of contraception during the trial and within 6 months of the last experimental drug administration;
Patients volunteered to participate in the trial and signed informed consent form with good compliance.
Exclusion Criteria:
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C553458 | apatinib |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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| "Capecitabine" | Drug | Single Drug "Capecitabine" to Maintain Treating Metastatic Colorectal Cancer |
|
|
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |