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Clinical Study of Apatinib Combined With Second - Line Chemotherapy for Metastatic Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT03412994
Recruitment Status : Not yet recruiting
First Posted : January 29, 2018
Last Update Posted : January 29, 2018
Sponsor:
Information provided by (Responsible Party):
Liqiang Zhong, The Second People's Hospital of Yibin

Brief Summary:
(1) Evaluate the efficacy of apatinib in combination with standard second-line chemotherapy for advanced colorectal cancer. Whether it can prolong Progression Free Survival (PFS), overall survival (OS) in patients with advanced colorectal cancer and reduce symptoms and improve quality of life compared with standard second-line chemotherapy; (2) Observe the safety of apatinib for the treatment of advanced colorectal cancer.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Drug: Apatinib Drug: standard second-line chemotherapy Phase 2

Detailed Description:

Standard second line chemotherapy includes chemotherapy based on irinotecan or chemotherapy based on oxaliplatin.

Apatinib is a small-molecule tyrosine kinase inhibitor (TKI) that highly selectively binds to and strongly inhibits vascular endothelial growth factor receptor 2 (VEGFR-2), with a decrease in VEGF-mediated endothelial cell migration, proliferation, and tumor microvascular density. A phase II trail of Apatinib has been demonstrated that Apatinib is safe to treat the metastatic colorectal cancer and the disease control rate can reach 50%.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Parallel-controlled, Exploratory Clinical Trial of Second-line Chemotherapy With Second-line Chemotherapy Versus Second-line Chemotherapy With Apatinib in the Treatment of Metastatic Colorectal Cancer
Estimated Study Start Date : February 28, 2018
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Apatinib group

Apatinib combined with second-line chemotherapy (5-Fu combined with irinotecan or oxaliplatin standard regimen ) Apatinib tablets: 500 mg po qd . Continuous medication, the cycle is consistent with the chemotherapy cycle.

Oxaliplatin: Day 1, 130mg/m2, IV infusion. Capecitabine: Day 1-14, 1000mg/m2 Twice Daily, po. A total of 6 cycles, 3 weeks apart of chemotherapy.(Take CAPEOX for example)

Drug: Apatinib
Apatinib in combination with standard second-line chemotherapy for advanced colorectal cancer
Other Name: YN968D1

Drug: standard second-line chemotherapy
The second line standard chemotherapy regimen recommended by the NCCN
Other Name: FOLFOX、FOLFIRI、CapeOX

Placebo Comparator: Control group
Oxaliplatin: Day 1, 130mg/m2, IV infusion. Capecitabine: Day 1-14, 1000mg/m2 Twice Daily, po. A total of 6 cycles, 3 weeks apart of chemotherapy.(Take CAPEOX for example)
Drug: standard second-line chemotherapy
The second line standard chemotherapy regimen recommended by the NCCN
Other Name: FOLFOX、FOLFIRI、CapeOX




Primary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: Approximately 2 year ]
    the time from randomize to progression or death; RECIST guidelines were used to define all responses after patients had received every 4 weeks of therapy


Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: Approximately 3 years ]
    Defined as the time from randomize to death

  2. Objective Response Rate (ORR) [ Time Frame: Approximately 2 years ]
    ORR=complete response (CR) + partial response (PR)

  3. Disease control rate(DCR) [ Time Frame: Approximately 2 years ]
    Defined as the rate of complete response , partial response and stable disease according to RECIST guidelines

  4. Quality of life(QoL) [ Time Frame: Approximately 2 year ]
    As measured by the European Organization for Research and Treatment of Cancer questionnaire (EORTC QLQ C30)



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female aged 18 to 70 years old;
  2. Histologically or cytologically proven patients with metastatic colorectal cancer have undergone a first-line standard regimen recommended by the NCCN guidelines for progression;
  3. According to the RECIST 1.1 criteria, the patient has at least one target lesion that can measure the diameter;
  4. ECOG PS ≤ 2;
  5. Expected survival time of more than 12 weeks.
  6. The level of organ function must meet the following requirements:

    Bone marrow: neutrophil count (ANC) ≥ 1.5 × 10^9/L, platelet ≥ 75 × 10^9/L, hemoglobin ≥ 90g/L.

    Liver: serum bilirubin ≤ 2 times the upper limit of normal, aminotransferase AST and ALT ≤ 2.5 times the normal upper limit.

    Kidney: Serum creatinine ≤1.5 times upper limit of normal.

  7. Patient compliance is good;
  8. Understand and voluntarily sign a written informed consent.

Exclusion Criteria:

  1. Other previous or concurrent malignancy, except cured skin basal cell carcinoma and cervical carcinoma in situ;
  2. Already known to be allergic to apatinib or any excipient;
  3. Use unapproved drugs or other test medications within 4 weeks prior to enrollment;
  4. There are many factors that affect oral medications (such as inability to swallow, chronic diarrhea and intestinal obstruction);
  5. Patients with a history of CNS metastases or CNS metastases;
  6. A history of bleeding, with any serious grading within 4 weeks prior to screening reaching a bleeding event of 3 degrees Celsius or greater in CTCAE4.0;
  7. Serious infection;
  8. Serious cardiovascular disease: uncontrolled hypertension, unstable angina, grade 3-4 heart failure (NYHA standard), congestive heart failure;
  9. urinary routine urinary protein ≥ ++ and confirmed 24-hour urinary protein quantitation> 1.0 g;
  10. Within 30 days after major surgery;
  11. Thrombotic disease. Anemia or venous thrombosis occurred in the previous year, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, pulmonary embolism, etc.;
  12. Those with history of psychotropic substance abuse who can not be abstinent or have mental disorders;
  13. Have clinical symptoms, need clinical intervention pleural effusion or ascites;
  14. At the investigator's discretion, there is a serious concomitant condition that compromises the patient's safety or affects the patient in completing the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03412994


Contacts
Contact: Liqiang Zhong 15283572951 zhongliqiang@163.com

Sponsors and Collaborators
Liqiang Zhong
Investigators
Study Chair: Liqiang Zhong Yibin Second People's Hospital

Responsible Party: Liqiang Zhong, deputy director of the physicians, The Second People's Hospital of Yibin
ClinicalTrials.gov Identifier: NCT03412994     History of Changes
Other Study ID Numbers: ChiCTR1800014478
First Posted: January 29, 2018    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases