search
Back to results

Anlotinib Hydrochloride Combined With Capeox in the Neoadjuvant Treatment of Locally Advanced Rectal Cancer

Primary Purpose

Neoadjuvant Treatment, Rectal Cancer, Anlotinib

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Anlotinib+Capeox
Capeox
Sponsored by
Shanghai Minimally Invasive Surgery Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoadjuvant Treatment focused on measuring Neoadjuvant Treatment, Rectal cancer, Anlotinib

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subjects voluntarily join the study and sign an informed consent form, have good compliance and cooperate with follow-up;
  2. Male or female patients between the ages of 18-75;
  3. Patients diagnosed as rectal adenocarcinoma by histology or cytology;
  4. Stage: Locally advanced stage (T3-4N0M0 or T1-4N+M0);
  5. Evaluation of middle and low rectal cancer with the lower pole of the tumor less than 12 cm from the anal margin by MRI;
  6. Have not received other anti-angiogenic drugs or chemotherapy drugs in the past;
  7. ECOG (Eastern US Cooperative Oncology Group) score: 0-1 points;
  8. Has sufficient organ and bone marrow function

Exclusion Criteria:

  1. Other malignant tumors that have appeared or are currently suffering from within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) ) And T1 (tumor infiltration basement membrane)];
  2. A distant transfer occurs;
  3. Those who have multiple factors that affect oral medications (such as inability to swallow, chronic diarrhea, etc.);
  4. Accompanied by pleural effusion or ascites, causing respiratory syndrome (NCI-CTC AE V5.0 grade ≥ 2 dyspnea);
  5. Patients with any severe and/or uncontrollable disease;
  6. Patients with gastrointestinal diseases with bleeding tendency (such as active gastrointestinal ulcers) or patients determined by the researcher to cause gastrointestinal bleeding, perforation or obstruction
  7. Patients whose imaging shows that the tumor has invaded the tissues around important blood vessels or the investigator judges that the tumor is likely to invade important blood vessels and cause fatal bleeding during the follow-up study;
  8. Received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before grouping;
  9. Regardless of the severity, patients with any signs of bleeding or medical history; within 4 weeks before grouping, patients with any bleeding or bleeding events NCI-CTC AE V5.0 grade ≥ 3, unhealed wounds, ulcers Or fracture
  10. Those who have had arterial/venous thrombotic events within 6 months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism;
  11. People with a history of psychotropic drug abuse and unable to quit or have mental disorders;
  12. Participated in other anti-tumor drug clinical trials within four weeks;
  13. According to the judgment of the investigator, those with concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study;
  14. Female patients who are pregnant or breastfeeding;
  15. Known hypersensitivity to any study drug.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Anlotinib+Capeox

    Capeox

    Arm Description

    neoadjuvant treatment with Anlotinib hydrochloride combined with Capeox

    neoadjuvant treatment with Capeox

    Outcomes

    Primary Outcome Measures

    Objective Response Rate(ORR)
    Refers to the proportion of subjects whose tumors have shrunk to a certain amount and maintained for a certain period of time in the FAS concentration, including CR and PR cases

    Secondary Outcome Measures

    Pathological complete response rate
    Refers to the pathological examination of primary tumors and lymph node surgical specimens without residual infiltrating tumor cells (ypT0N0)
    R0 resection rate
    Refers to the surgically removed tissue without residual cancer cells
    Local disease recurrence time
    Refers to the tumor reappearing at or near the same site as the primary cancer. The starting time is the first day after surgery.
    Overall survive
    Refers to the time from the start of randomization to death due to any cause. The starting time is the first day after surgery.
    Disease-free survival rate
    It refers to the time from the beginning of randomization to the incurable resection, local recurrence or metastasis, or death from any cause. The starting time is the first day after surgery.
    Postoperative complications
    Postoperative complications

    Full Information

    First Posted
    October 29, 2020
    Last Updated
    September 22, 2021
    Sponsor
    Shanghai Minimally Invasive Surgery Center
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04620473
    Brief Title
    Anlotinib Hydrochloride Combined With Capeox in the Neoadjuvant Treatment of Locally Advanced Rectal Cancer
    Official Title
    Anlotinib Hydrochloride Combined With Capeox in the Neoadjuvant Treatment of Locally Advanced Rectal cancer-a Prospective, Open, Single Center and Randomized Controlled Phase Ⅱ Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    No approval from ethical committee
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    December 1, 2023 (Anticipated)
    Study Completion Date
    October 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shanghai Minimally Invasive Surgery Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    Prospectively Investigate the effectiveness and safety of anlotinib hydrochloride combined with Capeox in neoadjuvant treatment of patients with locally advanced rectal cancer.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neoadjuvant Treatment, Rectal Cancer, Anlotinib
    Keywords
    Neoadjuvant Treatment, Rectal cancer, Anlotinib

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Anlotinib+Capeox
    Arm Type
    Experimental
    Arm Description
    neoadjuvant treatment with Anlotinib hydrochloride combined with Capeox
    Arm Title
    Capeox
    Arm Type
    Active Comparator
    Arm Description
    neoadjuvant treatment with Capeox
    Intervention Type
    Drug
    Intervention Name(s)
    Anlotinib+Capeox
    Intervention Description
    to use Anlotinib hydrochloride combined with Capeox in the neoadjuvant treatment of locally advanced rectal cancer
    Intervention Type
    Drug
    Intervention Name(s)
    Capeox
    Intervention Description
    to use Capeox in the neoadjuvant treatment of locally advanced rectal cancer
    Primary Outcome Measure Information:
    Title
    Objective Response Rate(ORR)
    Description
    Refers to the proportion of subjects whose tumors have shrunk to a certain amount and maintained for a certain period of time in the FAS concentration, including CR and PR cases
    Time Frame
    an average of three months
    Secondary Outcome Measure Information:
    Title
    Pathological complete response rate
    Description
    Refers to the pathological examination of primary tumors and lymph node surgical specimens without residual infiltrating tumor cells (ypT0N0)
    Time Frame
    one month after surgery
    Title
    R0 resection rate
    Description
    Refers to the surgically removed tissue without residual cancer cells
    Time Frame
    one month after surgery
    Title
    Local disease recurrence time
    Description
    Refers to the tumor reappearing at or near the same site as the primary cancer. The starting time is the first day after surgery.
    Time Frame
    3 years after surgery
    Title
    Overall survive
    Description
    Refers to the time from the start of randomization to death due to any cause. The starting time is the first day after surgery.
    Time Frame
    3 years after surgery
    Title
    Disease-free survival rate
    Description
    It refers to the time from the beginning of randomization to the incurable resection, local recurrence or metastasis, or death from any cause. The starting time is the first day after surgery.
    Time Frame
    3 years after surgery
    Title
    Postoperative complications
    Description
    Postoperative complications
    Time Frame
    one month after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects voluntarily join the study and sign an informed consent form, have good compliance and cooperate with follow-up; Male or female patients between the ages of 18-75; Patients diagnosed as rectal adenocarcinoma by histology or cytology; Stage: Locally advanced stage (T3-4N0M0 or T1-4N+M0); Evaluation of middle and low rectal cancer with the lower pole of the tumor less than 12 cm from the anal margin by MRI; Have not received other anti-angiogenic drugs or chemotherapy drugs in the past; ECOG (Eastern US Cooperative Oncology Group) score: 0-1 points; Has sufficient organ and bone marrow function Exclusion Criteria: Other malignant tumors that have appeared or are currently suffering from within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) ) And T1 (tumor infiltration basement membrane)]; A distant transfer occurs; Those who have multiple factors that affect oral medications (such as inability to swallow, chronic diarrhea, etc.); Accompanied by pleural effusion or ascites, causing respiratory syndrome (NCI-CTC AE V5.0 grade ≥ 2 dyspnea); Patients with any severe and/or uncontrollable disease; Patients with gastrointestinal diseases with bleeding tendency (such as active gastrointestinal ulcers) or patients determined by the researcher to cause gastrointestinal bleeding, perforation or obstruction Patients whose imaging shows that the tumor has invaded the tissues around important blood vessels or the investigator judges that the tumor is likely to invade important blood vessels and cause fatal bleeding during the follow-up study; Received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before grouping; Regardless of the severity, patients with any signs of bleeding or medical history; within 4 weeks before grouping, patients with any bleeding or bleeding events NCI-CTC AE V5.0 grade ≥ 3, unhealed wounds, ulcers Or fracture Those who have had arterial/venous thrombotic events within 6 months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism; People with a history of psychotropic drug abuse and unable to quit or have mental disorders; Participated in other anti-tumor drug clinical trials within four weeks; According to the judgment of the investigator, those with concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study; Female patients who are pregnant or breastfeeding; Known hypersensitivity to any study drug.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Anlotinib Hydrochloride Combined With Capeox in the Neoadjuvant Treatment of Locally Advanced Rectal Cancer

    We'll reach out to this number within 24 hrs