Colorectal Cancer
Conditions
Interventions
Experimental group:intravenous arsenic trioxide
Sponsors
Sir Run Run Shaw Hospital affiliated to Medical College of Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients who meet all of the following selection criteria are eligible for this study: 1) Prior to the implementation of procedures related to any research program rather than routine care, the informed consent form signed and dated by the subject must be obtained in accordance with regulations and institutional guidelines. 2) Aged >= 18 years. 3) There is definite histological evidence to prove that it is adenocarcinoma of colon or rectum. 4) The score of ECOG physical status was 0-1. 5) distant metastasis of colon or rectal adenocarcinoma was confirmed by CT or MR evaluation, and according to RECISTv1.1 criterion, at least one measurable lesion was confirmed by independent central imaging, and after multidisciplinary discussion, it was considered that there was no local treatment at present or in the near future (operation, intervention, radiotherapy, etc.). 6) Patients with metastatic colorectal cancer who have previously received at least second-line standard regimens, including fluorouracil, oxaliplatin and irinotecan. 7) The following laboratory tests obtained on the first day of each treatment cycle within 7 days before treatment, Have appropriate organ function: hemoglobin >= 90g/L, neutrophil count >= 1.5x10^9 / L, platelet count >= 75 x 10^9 / L, serum total bilirubin <= 1.5 x normal upper limit (UNL), aspartate transferase <= 2 x UNL, alanine transferase <= 3 x UNL, serum creatinine <= 1.5 x UNL 8) are willing and able to abide by the research procedure and visit plan. 9) the structural mutant p53 gene mutation was confirmed by the central laboratory. 10) recurrence or progression of the disease less than 6 months after the end of the last standard treatment for colorectal cancer.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following conditions will be excluded from the study: 1) patients with severe infection, obstruction, active bleeding or perforation require emergency surgery or stent placement. 2) there are other active malignant tumors in the past or at the same time (except malignant tumors that have been cured for more than 5 years or cancer in situ that can be cured by adequate treatment). 3) in the previous 2 weeks, he had undergone major operations such as laparotomy, thoracotomy, laparoscopic resection of organs or severe trauma. 4) there was active coronary artery disease, severe / unstable angina pectoris or newly diagnosed angina pectoris or myocardial infarction within 12 months before participating in the study. 5) Thrombosis or embolism occurred in the past 6 months, such as cerebrovascular accident (including transient ischemic attack), pulmonary embolism and deep venous thrombosis. 6) congestive heart failure with grade (NYHA) II or above of New York Heart Association. 7) it is known that there is human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)-related diseases, or active hepatitis B or C hepatitis. 8) there is active inflammatory bowel disease or other colorectal diseases that cause chronic diarrhea. 9) there is any unresolved toxicity of CTCAE2 grade or above caused by previous treatment (except anemia, hair loss, skin pigmentation). 10) known or suspected history of allergies to any related drugs used in the study. 11) patients who plan to undergo local treatment (surgery, intervention, radiotherapy, etc.) in the near future. 12) pregnant or lactating women. 13) any medical condition that may affect patient safety and research compliance. 14) received radiotherapy less than 4 weeks before the first dose of the study drug, or chemotherapy, biotherapy, endocrine therapy or small molecule targeted therapy before the first dose of the study drug (distance from the first dose of the study drug, elution >= 5 half-lives can be included in the group). 15) deficiency of hematopoietic function or organ function (correction with blood products, such as blood transfusion, etc.) is not allowed within 14 days before the first dose of the drug is studied.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;progression-free survival;Clinical benefit rate;Disease control rate; | — |
Countries
China
Contacts
Public ContactZhangfa Song
Sir Run Run Shaw Hospital affiliated to Medical College of Zhejiang University
Outcome results
None listed