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Withdrawn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
About this trial
This is an interventional treatment trial for Neoadjuvant Treatment focused on measuring Neoadjuvant Treatment, Rectal cancer, Anlotinib
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.
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
NCT ID
NCT04620473
First Posted
October 29, 2020
Last Updated
September 22, 2021
Sponsor
Shanghai Minimally Invasive Surgery Center
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
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