<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03813641</url>
  </required_header>
  <id_info>
    <org_study_id>Shenzhen CRC-002</org_study_id>
    <nct_id>NCT03813641</nct_id>
  </id_info>
  <brief_title>RALOX or CAPOX + Bevacizumab in the First-line Treatment of Advanced CRC(ROCB Study)</brief_title>
  <official_title>Phase Ⅱ Clinical Study of RALOX or CAPOX Combined With Bevacizumab in the First-line Treatment of Advanced Colorectal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shenzhen People's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shenzhen People's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Raltitrexed is an inhibitor of thymidylate synthase.As a folate antimetabolite drug,&#xD;
      raltitrexed has been used in treatment of colorectal cancer(CRC) since 1998, and also used in&#xD;
      malignant mesothelioma.Several phase III studies performed in patients with advanced CRC&#xD;
      showed that it is as effective as 5-fluorouracil(5-FU) /leucovorin(LV) with regard to&#xD;
      response rates and survival. The combination of raltitrexed with oxaliplatin shows response&#xD;
      rates of 41%-54% and median survivals of 14.6-14.8 months, which are comparable to those&#xD;
      achieved with 5-FU/LV combination with oxaliplatin. This study discussed the efficacy and&#xD;
      safety of raltitrexed-oxaliplatin(RALOX) combined with bevacizumab or&#xD;
      capecitabine-oxaliplatin(CAPOX) combined with bevacizumab in first-line treatment of patients&#xD;
      with advanced colorectal cancer who could not undergo radical surgery. The main endpoint will&#xD;
      be progression free survival (PFS). The secondary endpoints will be overall survival,&#xD;
      objective response rate and disease control rate (OS,ORR and DCR).It is expected that&#xD;
      raltitrexed may be one of options for the treatment of advanced CRC in the first-line&#xD;
      setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      According to the inclusion and exclusion criteria, the patients will be randomly divided into&#xD;
      two groups: the experimental group (group A) will be administered with raltitrexed 3mg/m2&#xD;
      intravenously combined with oxaliplatin and bevacizumab, repeated every 21 days. The control&#xD;
      group (group B) will be administered with orally capecitabine (1000mg/m2, d 1-14) combined&#xD;
      with oxaliplatin and bevacizumab, repeated every 21 days. After 8 cycles of treatments, if&#xD;
      evaluated as complete response(CR),partial response(PR) or stable disease(SD), CRC patients&#xD;
      will go into maintenance therapy wtih raltitrexed combined with bevacizumab in group A or&#xD;
      capecitabine combined with bevacizumab in group B respectively, ended in disease&#xD;
      progression(PD) , symptoms deterioration, unacceptable toxicity, death or withdrawal of&#xD;
      consent (whichever occurs first). The radiological efficacy will be evaluated every 6 weeks&#xD;
      (2 treatment cycles) and non-PD (PD criteria referring to RECIST 1.1 criteria) patients will&#xD;
      continue to be treated until the cancer progression or the patient's intolerable toxicity or&#xD;
      death. Toxic side effects and quality of life will be assessed at the same time.&#xD;
&#xD;
      Follow up participants and analyse primary endpoint (PFS) and secondary endpoints (OS,ORR and&#xD;
      DCR).The causes of confirmed missing data in the trial should be recorded in detail to&#xD;
      determine the mechanism of missing data and choose the suitable missing data handling&#xD;
      methods.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 28, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">February 28, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Randomized controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression-free Survival (PFS) Time</measure>
    <time_frame>The follow-up period ranges from the first patient recruited to the last patient within 6 months after admission, up to 2 years.</time_frame>
    <description>PFS is defined as the time from the date of randomization until the date of objectively determined progressive disease (PD) [according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v). 1.1] or death due to any cause, whichever will be first. PD is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). Participants who died without a reported prior progression will be considered to have progressed on the day of their death. Participants who do not progress or be lost to follow-up will be censored at the day of their last radiographic tumor assessment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>The follow-up period ranges from the first patient recruited to the last patient within 6 months after admission,up to 2 years.</time_frame>
    <description>OS is defined as the time in months from the date of randomization to the date of death from any cause. For participants not known to have died as of the cut-off date, OS will be censored at the last known date alive.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving an Objective Response (Objective Response Rate)</measure>
    <time_frame>The follow-up period ranges from the first patient recruited to the last patient within 3 months after admission.</time_frame>
    <description>The objective response rate is equal to the proportion of participants achieving a best overall response of partial response or complete response (PR + CR). Response is defined using RECIST, v. 1.1 criteria. CR is defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt;10 mm and normalization of tumor marker level of non-target lesions; PR is defined as having at least a 30% decrease in sum of longest diameter of target lesions taking as reference the baseline sum diameter.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving a Stable Disease (SD) or a confirmed CR or PR (Disease Control Rate)</measure>
    <time_frame>The follow-up period ranges from the first patient recruited to the last patient within 3 months after admission.</time_frame>
    <description>Participants achieved disease control if they have a best overall response of CR, PR or SD. According to RECIST v1.1, CR is the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to &lt;10 mm, the disappearance of all non-target lesions, and the normalization of tumor marker levels (if tumor markers were initially above the ULN); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. SD is neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>RALOX + bevacizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oxaliplatin 130mg/m2, i.v.gtt 2h, d1 Raltitrexed 3mg/m2, i.v.gtt 15min ,d1 Bevacizumab 7.5mg/kg, i.v.gtt, d1 The above schemes are repeated every three weeks. After 8 cycles, such as CR, PR or SD, the regimen is changed to raltitrexed (3mg/m2, intravenous drip for 15 minutes, d1)+bevacizumab (7.5mg/kg, intravenous drip, d1). The regimen is repeated every 3 weeks until the disease progresses.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CAPOX + bevacizumab</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Oxaliplatin 130mg/m2, i.v.gtt 2h, d1 Capecitabine 1000mg/m2, po. ,d1 Bevacizumab 7.5mg/kg, i.v.gtt, d1 The above schemes are repeated every three weeks. After 8 cycles, such as CR, PR or SD, the regimen is changed to Capecitabine (1000mg/m2 po. d1-14)+bevacizumab (7.5mg/kg, intravenous drip, d1). The regimen is repeated every 3 weeks until the disease progresses.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Raltitrexed</intervention_name>
    <description>Experimental: Oxaliplatin + Raltitrexed + Bevacizumab The above schemes are repeated every three weeks. After 8 cycles, such as CR, PR or SD, the regimen is changed to Raltitrexed (3mg/m2, intravenous drip for 15 minutes, d1)+bevacizumab (7.5mg/kg, intravenous drip, d1). The regimen is repeated every 3 weeks until the disease progresses.</description>
    <arm_group_label>RALOX + bevacizumab</arm_group_label>
    <other_name>Tomudex</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Capecitabine</intervention_name>
    <description>Other: Oxaliplatin + Capecitabine + Bevacizumab The above schemes are repeated every three weeks. After 8 cycles, such as CR, PR or SD, the regimen is changed to Capecitabine (1000mg/m2 po. d1-14)+bevacizumab (7.5mg/kg, intravenous drip, d1). The regimen is repeated every 3 weeks until the disease progresses.</description>
    <arm_group_label>CAPOX + bevacizumab</arm_group_label>
    <other_name>Xeloda</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18~75 years;&#xD;
&#xD;
          -  Patients are diagnosed by histopathological and/or cytological examination as local&#xD;
             advanced or metastatic colorectal cancer who are unable to undergo radical surgery&#xD;
             with no symptom of the primary lesions；&#xD;
&#xD;
          -  There are one or more measurable lesions, the longest diameter of which is at least 10&#xD;
             mm by spiral CT scanning (RECIST standard, version 1.1)&#xD;
&#xD;
          -  ECOG performance status (ECOG PS) 0~1;&#xD;
&#xD;
          -  Life expectancy not less than 3 month&#xD;
&#xD;
          -  Blood routine, liver and kidney function reached the following criteria within 14 days&#xD;
             before screening:&#xD;
&#xD;
        Absolute neutrophil count (&gt; 1.5x109/L); hemoglobin (&gt; 9.0 g/dl); platelet count (&gt; 100&#xD;
        x109/L); total bilirubin (&lt; 1.5 times the normal upper limit (ULN); alanine&#xD;
        aminotransferase and glutamic oxaloacetate aminotransferase (&lt; 2.5 x ULN) in patients with&#xD;
        liver metastasis (&lt; 5 x ULN); alkaline phosphatase （&lt; 3 x ULN（ in patients with liver&#xD;
        metastasis &lt; 5 x ULN)）; serum creatinine （&lt; 1.5 x ULN）;&#xD;
&#xD;
          -  Adequate blood coagulation function [International Normalized Ratio (INR) ≤1.5 and&#xD;
             Partial Thromboplastin Time (PTT) or activated PTT (aPTT) ≤1.5 x upper limit of normal&#xD;
             (ULN)). Participants on full-dose anticoagulation must be in a stable phase of&#xD;
             anticoagulant therapy and if taking oral anticoagulation, participants must have an&#xD;
             INR ≤3 without clinically significant active bleeding or a high risk of bleeding.&#xD;
&#xD;
          -  Agree to provide histological specimens from previous operations for biomarker&#xD;
             assessment and specimens remain。&#xD;
&#xD;
          -  Signed informed consent to be provided&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous treatment with Raltitrexed；&#xD;
&#xD;
          -  With a large amount of pleural effusions or ascites requiring puncture drainage；&#xD;
&#xD;
          -  Active clinical severe infections include hepatitis；&#xD;
&#xD;
          -  One of the following complications: 1) Gastrointestinal obstruction (including&#xD;
             paralytic ileus) or gastrointestinal bleeding 2) Symptomatic cardiac disease&#xD;
             (including unstable angina, myocardial infarction, and heart failure) 3) Pulmonary&#xD;
             fibrosis or interstitial pneumonia 4) Uncontrolled diabetes mellitus 5) Uncontrolled&#xD;
             diarrhea (that affects daily activities although adequate therapy )&#xD;
&#xD;
          -  Symptomatic brain or meningeal metastasis (unless the patient has been treated for &gt; 6&#xD;
             months, the imaging results are negative in the 4 weeks before entering the study, and&#xD;
             the clinical symptoms associated with the tumor are stable at the time of entering the&#xD;
             study);&#xD;
&#xD;
          -  Undergoing kidney dialysis；&#xD;
&#xD;
          -  History of other malignant tumors within 5 years, except for cured cervical carcinoma&#xD;
             in situ or basal cell carcinoma of the skin;&#xD;
&#xD;
          -  Drug abuse and medical, psychological or social conditions may interfere with&#xD;
             patients' participation in the study or have an impact on the evaluation of the study&#xD;
             results；&#xD;
&#xD;
          -  Pregnant or lactating females, and males and females reluctant to use contraception&#xD;
&#xD;
          -  History of concurrent gastrointestinal perforation or gastrointestinal perforation&#xD;
             within 1 year prior to enrollment&#xD;
&#xD;
          -  Pulmonary hemorrhage/hemoptysis ≥ Grade 2 (identified as bright red blood of not less&#xD;
             2.5mL) within 1 month before enrollment.&#xD;
&#xD;
          -  History of thoracotomy,laparotomy, or intestinal resection within 28 days prior to&#xD;
             enrollment;&#xD;
&#xD;
          -  Unhealed wound (other than suture wounds due to implantation of a central venous&#xD;
             port), traumatic fracture, or gastrointestinal ulcer&#xD;
&#xD;
          -  Current cerebrovascular disease or thromboembolism or either within 1 year before&#xD;
             enrollment&#xD;
&#xD;
          -  Current anticoagulation therapy or requiring anticoagulation agents (&gt; 325 mg/day of&#xD;
             aspirin)&#xD;
&#xD;
          -  Bleeding diathesis, coagulopathy, or coagulation factor abnormality (INR ≥1.5 within&#xD;
             14 days before enrollment)&#xD;
&#xD;
          -  Uncontrolled hypertension&#xD;
&#xD;
          -  Urine dipstick for proteinuria &gt;+2&#xD;
&#xD;
          -  Researchers think those should be excluded&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ruilian Xu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shen Zhen People's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ruilian Xu, MD</last_name>
    <phone>+8675522942497</phone>
    <email>xuruilian@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Wan He, MD,phD</last_name>
    <phone>+8675522942411</phone>
    <email>hewanshenzhen@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Shenzhen People's Hospital</name>
      <address>
        <city>Shenzhen</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ruilian Xu, MD</last_name>
      <phone>+8675522942497</phone>
      <email>xuruilian@126.com</email>
    </contact>
    <contact_backup>
      <last_name>Wan He, MD,PhD</last_name>
      <phone>+8675522942449</phone>
      <email>hewanshenzhen@hotmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
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  <verification_date>September 2019</verification_date>
  <study_first_submitted>January 20, 2019</study_first_submitted>
  <study_first_submitted_qc>January 20, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>September 5, 2019</last_update_submitted>
  <last_update_submitted_qc>September 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shenzhen People's Hospital</investigator_affiliation>
    <investigator_full_name>Ruilian Xu</investigator_full_name>
    <investigator_title>Phase Ⅱ Clinical Study of RALOX or CAPOX Combined With Bevacizumab in the First-line Treatment of Advanced Colorectal Cancer</investigator_title>
  </responsible_party>
  <keyword>Raltitrexed</keyword>
  <keyword>First-line therapy</keyword>
  <keyword>Bevacizumab</keyword>
  <keyword>Colorectal Cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Capecitabine</mesh_term>
    <mesh_term>Raltitrexed</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03813641
org study id: Shenzhen CRC-002
nct id: NCT03813641
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Raltitrexed is an inhibitor of thymidylate synthase.As a folate antimetabolite drug,
      raltitrexed has been used in treatment of colorectal cancer(CRC) since 1998, and also used in
      malignant mesothelioma.Several phase III studies performed in patients with advanced CRC
      showed that it is as effective as 5-fluorouracil(5-FU) /leucovorin(LV) with regard to
      response rates and survival. The combination of raltitrexed with oxaliplatin shows response
      rates of 41%-54% and median survivals of 14.6-14.8 months, which are comparable to those
      achieved with 5-FU/LV combination with oxaliplatin. This study discussed the efficacy and
      safety of raltitrexed-oxaliplatin(RALOX) combined with bevacizumab or
      capecitabine-oxaliplatin(CAPOX) combined with bevacizumab in first-line treatment of patients
      with advanced colorectal cancer who could not undergo radical surgery. The main endpoint will
      be progression free survival (PFS). The secondary endpoints will be overall survival,
      objective response rate and disease control rate (OS,ORR and DCR).It is expected that
      raltitrexed may be one of options for the treatment of advanced CRC in the first-line
      setting.
According to the inclusion and exclusion criteria, the patients will be randomly divided into
      two groups: the experimental group (group A) will be administered with raltitrexed 3mg/m2
      intravenously combined with oxaliplatin and bevacizumab, repeated every 21 days. The control
      group (group B) will be administered with orally capecitabine (1000mg/m2, d 1-14) combined
      with oxaliplatin and bevacizumab, repeated every 21 days. After 8 cycles of treatments, if
      evaluated as complete response(CR),partial response(PR) or stable disease(SD), CRC patients
      will go into maintenance therapy wtih raltitrexed combined with bevacizumab in group A or
      capecitabine combined with bevacizumab in group B respectively, ended in disease
      progression(PD) , symptoms deterioration, unacceptable toxicity, death or withdrawal of
      consent (whichever occurs first). The radiological efficacy will be evaluated every 6 weeks
      (2 treatment cycles) and non-PD (PD criteria referring to RECIST 1.1 criteria) patients will
      continue to be treated until the cancer progression or the patient's intolerable toxicity or
      death. Toxic side effects and quality of life will be assessed at the same time.

      Follow up participants and analyse primary endpoint (PFS) and secondary endpoints (OS,ORR and
      DCR).The causes of confirmed missing data in the trial should be recorded in detail to
      determine the mechanism of missing data and choose the suitable missing data handling
      methods.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled trial
primary purpose: Treatment
masking: None (Open Label)
measure: Progression-free Survival (PFS) Time
time frame: The follow-up period ranges from the first patient recruited to the last patient within 6 months after admission, up to 2 years.
description: PFS is defined as the time from the date of randomization until the date of objectively determined progressive disease (PD) [according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v). 1.1] or death due to any cause, whichever will be first. PD is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). Participants who died without a reported prior progression will be considered to have progressed on the day of their death. Participants who do not progress or be lost to follow-up will be censored at the day of their last radiographic tumor assessment.
measure: Overall Survival (OS)
time frame: The follow-up period ranges from the first patient recruited to the last patient within 6 months after admission,up to 2 years.
description: OS is defined as the time in months from the date of randomization to the date of death from any cause. For participants not known to have died as of the cut-off date, OS will be censored at the last known date alive.
measure: Percentage of Participants Achieving an Objective Response (Objective Response Rate)
time frame: The follow-up period ranges from the first patient recruited to the last patient within 3 months after admission.
description: The objective response rate is equal to the proportion of participants achieving a best overall response of partial response or complete response (PR + CR). Response is defined using RECIST, v. 1.1 criteria. CR is defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm and normalization of tumor marker level of non-target lesions; PR is defined as having at least a 30% decrease in sum of longest diameter of target lesions taking as reference the baseline sum diameter.
measure: Percentage of Participants Achieving a Stable Disease (SD) or a confirmed CR or PR (Disease Control Rate)
time frame: The follow-up period ranges from the first patient recruited to the last patient within 3 months after admission.
description: Participants achieved disease control if they have a best overall response of CR, PR or SD. According to RECIST v1.1, CR is the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all non-target lesions, and the normalization of tumor marker levels (if tumor markers were initially above the ULN); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. SD is neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started.
arm group label: RALOX + bevacizumab
arm group type: Experimental
description: Oxaliplatin 130mg/m2, i.v.gtt 2h, d1 Raltitrexed 3mg/m2, i.v.gtt 15min ,d1 Bevacizumab 7.5mg/kg, i.v.gtt, d1 The above schemes are repeated every three weeks. After 8 cycles, such as CR, PR or SD, the regimen is changed to raltitrexed (3mg/m2, intravenous drip for 15 minutes, d1)+bevacizumab (7.5mg/kg, intravenous drip, d1). The regimen is repeated every 3 weeks until the disease progresses.
arm group label: CAPOX + bevacizumab
arm group type: Active Comparator
description: Oxaliplatin 130mg/m2, i.v.gtt 2h, d1 Capecitabine 1000mg/m2, po. ,d1 Bevacizumab 7.5mg/kg, i.v.gtt, d1 The above schemes are repeated every three weeks. After 8 cycles, such as CR, PR or SD, the regimen is changed to Capecitabine (1000mg/m2 po. d1-14)+bevacizumab (7.5mg/kg, intravenous drip, d1). The regimen is repeated every 3 weeks until the disease progresses.
intervention type: Drug
intervention name: Raltitrexed
description: Experimental: Oxaliplatin + Raltitrexed + Bevacizumab The above schemes are repeated every three weeks. After 8 cycles, such as CR, PR or SD, the regimen is changed to Raltitrexed (3mg/m2, intravenous drip for 15 minutes, d1)+bevacizumab (7.5mg/kg, intravenous drip, d1). The regimen is repeated every 3 weeks until the disease progresses.
arm group label: RALOX + bevacizumab
other name: Tomudex
intervention type: Drug
intervention name: Capecitabine
description: Other: Oxaliplatin + Capecitabine + Bevacizumab The above schemes are repeated every three weeks. After 8 cycles, such as CR, PR or SD, the regimen is changed to Capecitabine (1000mg/m2 po. d1-14)+bevacizumab (7.5mg/kg, intravenous drip, d1). The regimen is repeated every 3 weeks until the disease progresses.
arm group label: CAPOX + bevacizumab
other name: Xeloda
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Ruilian Xu, MD
role: Principal Investigator
affiliation: Shen Zhen People's Hospital
last name: Ruilian Xu, MD
phone: +8675522942497
email: xuruilian@126.com
last name: Wan He, MD,phD
phone: +8675522942411
email: hewanshenzhen@hotmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
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responsible party type: Principal Investigator
investigator affiliation: Shenzhen People's Hospital
investigator full name: Ruilian Xu
investigator title: Phase Ⅱ Clinical Study of RALOX or CAPOX Combined With Bevacizumab in the First-line Treatment of Advanced Colorectal Cancer
mesh term: Colorectal Neoplasms
mesh term: Capecitabine
mesh term: Raltitrexed
sharing ipd: No