Study of Apatinib and Capecitabine Combination to Maintain Treating Metastatic Colorectal Cancer

Study Overview
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Brief Summary
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To control apatinib and capecitabine combination to maintain treating metastatic colorectal cancer.

Detailed Description
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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.

Official Title
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Phase 1 Study of Apatinib and Capecitabine Combination to Maintain Treating Metastatic Colorectal Cancer

Conditions
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Metastatic Colorectal Cancer

Intervention / Treatment
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* Drug: Apatinib and Capecitabine
* Drug: Capecitabine


Participation Criteria
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Eligibility Criteria
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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: Hb≥9 g/dL Absolute neutrophil count ≥1.0 × 109 /L Platelet count≥75 × 109 /L Serum bilirubin ≤ 1.5 × ULN, which would not be appropriate for patients with Gilbert syndrome (Persistent or recurrent hyperbilirubinemia, mainly unconjugated bilirubin, with no evidence of hemolysis or abnormal liver pathology) which can consult a doctor ALT&AST ≤ 2.5 × ULN; for patients with liver metastases, ALT&AST ≤ 5 × ULN Calculate the creatinine clearance rate by Cockcroft-Gault formula Creatinine clearance rate measured( by actual body weight) or by measuring urine collection for 24 hours> 40 mL/min(the value of the measurement of the 24 - hour urine collection will be used to determine eligibility if the two methods are used) 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: Patients with hypertension and can not be reduced to the normal range with antihypertensive drugs(systolic pressure >140 mmHg / diastolic pressure > 90 mmHg),patients with coronary heart disease more than grade II, arrhythmia (including QTc interval Prolongation men>450 ms, women >470 ms) and cardiac insufficiency; With a variety of factors affecting oral drugs(such as unable to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction, etc.); Special note: patients with the risk of gastrointestinal bleeding can not be included, including the following: active peptic ulcer lesions and fecal occult blood (+ +); patients with melena and hematemesis in 3 months; for patients with fecal occult blood (+) and primary gastric tumor without surgery should be carried out gastroscopy, patients with ulcero carcinoma of stomach and believed to cause the lesion to bleed by the physician; Abnormal coagulation function(INR>1.5×ULN、 APTT>1.5×ULN) with bleeding tendency; With Symptomatic central nervous system metastasis; Pregnant or lactating women; Other patients unsuitable for inclusion considered by the physician.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A: apatinib and capecitabine<br>Arm A: apatinib and capecitabine apatinib 250mg qdpo; capecitabine 1000mg/m2 qdpo d1-14 q3w | Drug: Apatinib and Capecitabine<br>* Combine Apatinib and Capecitabine to Maintain Treating Metastatic Colorectal Cancer<br>* Other names: Arm A;|
| Active Comparator: B: capecitabine single drug<br>Arm B: capecitabine single drug capecitabine 1000mg/m2 qdpo d1-14 q3w | Drug: Capecitabine<br>* Single Drug Capecitabine to Maintain Treating Metastatic Colorectal Cancer<br>* Other names: Arm B;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastatic Colorectal Cancer, Apatinib, Capecitabine