colorectal cancer
Conditions
Interventions
experimental group:fuzhong xiaoji therapy
Control group:Placebo
Sponsors
Ruijin Hospital, Shanghai JiaoTong University, School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients who enter the group must sign an informed consent form after entering the initial screening; 2. Aged from 18 years old to 75 years old; 3. Histological pathology confirmed as "colorectal" adenocarcinoma; according to the 8th edition of the AJCC staging criteria, stage IIIC colorectal cancer patients; 4. Laparoscopic or open surgery R0 resection patients, and at least 6 cycles of CAPOX program or 8 cycles of FOLFOX6 regimen adjuvant chemotherapy, randomized into 2:1 group into clinical studies. The grouping time was within 2 months after the end of the last chemotherapy, and no recurrence and metastasis was found at enrollment time. 5. Patients with rectal cancer are allowed to receive perioperative radiation therapy (preoperative radiotherapy and chemotherapy, postoperative radiotherapy or chemotherapy or chemotherapy alone); 6. The general condition of the subjects is good, the ECOG score is 0-2, and the expected survival time is more than 6 months; 7. serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2.5 times the upper limit of normal, bilirubin = 1.5 times the upper limit of normal, creatinine = 1.5 times the upper limit of normal; no serious other complications, such as cardiac insufficiency Patients who are not suitable for clinical research; 8. Women of childbearing age need effective contraceptive measures (both male and female)
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women, women of childbearing age who do not use contraception; 2. After the completion of adjuvant therapy, the Chinese medicine treatment was evaluated to have disease metastasis or recurrence before enrollment; 3. The subject has a symptomatic heart disease (arrhythmia, cardiac insufficiency or history of myocardial infarction); 4. The subject has active infection, active bleeding or severe metabolic disorders; 5. The subject has a history of other malignancies (unless he has been cured for more than 5 years); 6. Undertake of other interventional clinical trials or the end of the previous clinical trials less than 3 treatment cycles; 7. The investigator determines other subjects who are not eligible to participate in the program.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease free survival;Disease free survival; | — |
Countries
China
Contacts
Public ContactLan zheng
Ruijin Hospital, Shanghai JiaoTong University, School of Medicine
Outcome results
None listed