Apatinib for Resectable Colorectal Cancer (NCT03228043) | Clinical Trial Compass
WithdrawnNot Applicable
Apatinib for Resectable Colorectal Cancer
Stopped: It's not possible to complete in our hospital.
China0Started 2020-03-01
Plain-language summary
Objective: To compare the outcome of patients with colorectal cancer who treated with adjuvant therapy or Apatinib with adjuvant therapy postoperatively.
Language: English.
Who can participate
Age range18 Years ā 75 Years
SexALL
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Inclusion criteria
ā. ECOG performance status score: 0-1.
ā. All colorectal cancer patients underwent curative intent surgery
ā. Patients in stage ā ”(Any T, N0, M0) with multiple high-risk factors or stage ā ¢ (any T, N1-2, M0) which confirmed by pathology.
ā. Patients who did not receive other treatments for colorectal adenocarcinoma after surgery;
ā. The main organ function is good, patients must meet the following requirements with 14 days before using Apatinib:
ā. The surgical incision has been healed, and no bleeding tendency;
ā. Sign informed consent;
ā. Compliance is good, family members agreed to accept survival follow-up.
Exclusion criteria
ā. Patients with other malignancies, except for cured skin basal cell carcinoma and cervical cancer in situ.
ā. Participated in other drug clinical trials within four weeks.
ā. Have a variety of factors that affect oral medication (such as unable to swallow, chronic diarrhea and intestinal obstruction, etc.).
ā. Have a history of bleeding, screening within 4 weeks before any serious grade to CTCAE4.0 3 degrees or more bleeding events.
. Patients with central nervous system metastases or a history of central nervous system metastases before screening. For patients with suspected central nervous system metastases, CT or MRI examinations must be performed within 28 days prior to randomization to exclude central nervous system metastasis.
ā. History of high blood pressure can not be controlled with a single antihypertensive drug therapy (With a systolic blood pressure\> 140 mmHg, diastolic blood pressure\> 90 mmHg. A history of unstable angina within 3 months or a new diagnosis of angina within 6 months (Including QTcF: male ā„ 450 ms, female ā„470 ms) required long-term use of antiarrhythmic drugs and New York Heart Association classification ā„ Class II cardiac insufficiency.
ā. Urinary protein ā„ ++ and urine protein\> 1.0 g in 24 hours.
ā. Patients with anastomotic fistula, pancreatic fistula or anastomotic stenosis and other serious postoperative complications.