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

Overview

To control apatinib and capecitabine combination to maintain treating metastatic colorectal cancer.

Full Title of Study: “Phase 1 Study of Apatinib and Capecitabine Combination to Maintain Treating Metastatic Colorectal Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: February 28, 2018

Detailed Description

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.

Interventions

  • Drug: “Apatinib” and “Capecitabine”
    • Combine “Apatinib” and “Capecitabine” to Maintain Treating Metastatic Colorectal Cancer
  • Drug: “Capecitabine”
    • Single Drug “Capecitabine” to Maintain Treating Metastatic Colorectal Cancer

Arms, Groups and Cohorts

  • Experimental: A: “apatinib” and “capecitabine”
    • Arm A: “apatinib” and “capecitabine” apatinib 250mg qdpo; capecitabine 1000mg/m2 qdpo d1-14 q3w
  • Active Comparator: B: “capecitabine” single drug
    • Arm B: “capecitabine” single drug “capecitabine” 1000mg/m2 qdpo d1-14 q3w

Clinical Trial Outcome Measures

Primary Measures

  • Progression-free Survival of Patients with Apatinib and Capecitabine Combination That is prolonged
    • Time Frame: up to 10 months
    • Patients with double drug group have more longer progression-free survival (PFS) than patients with single drug group

Participating in This Clinical Trial

Inclusion Criteria

1. Informed consent form should be issued prior to conducting any research process; 2. Men or women aged 18-75 years; 3. Patients with advanced and / or metastatic colorectal cancer confirmed by histology or cytology; 4. Patients who has not exposed to apatinib previously and had received oxaliplatin combined with fluorouracil chemotherapy; 5. The estimated survival time is longer than 3 months; 6. ECOG score was 0 or 1; 7. 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; 8. 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) 9. 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; 10. Patients volunteered to participate in the trial and signed informed consent form with good compliance. Exclusion Criteria:

1. 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; 2. With a variety of factors affecting oral drugs(such as unable to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction, etc.); 3. 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; 4. Abnormal coagulation function(INR>1.5×ULN、 APTT>1.5×ULN) with bleeding tendency; 5. With Symptomatic central nervous system metastasis; 6. Pregnant or lactating women; 7. Other patients unsuitable for inclusion considered by the physician.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Yanqiao Zhang
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Yanqiao Zhang, Head of Gastroenterology – Harbin Medical University

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