ITMCTR2100005329招募中1 期
TCM evidence-based capacity building and evidence-based implementation plan of TCM combined with chemotherapy in treatment of metastatic colorectal cancer:A bidirectional cohort study of Zhenqiliujun anti-cancer granules combined with mFOLFOX6/FOLFIRI regimen and bevacizumab/cetuximab in first-line treatment of advanced metastatic colorectal
Department of Oncology, Affiliated Hospital of Traditional Chinese Medicine, Southwest Medical University0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 性别
- All
入选标准
- •1. Diagnosis of advanced metastatic colorectal cancer by pathology and/or cytology (diagnosis of simultaneous metastasis and postoperative recurrence of atypical metastasis, previous adjuvant chemotherapy or radiotherapy with atypical metastasis for more than 3 months were included);
- •2. Aged 18 ~ 75 years(including boundary value), male or female;
- •3. ECOG PS score 0-2; [Zubrod-Ecog-Who (ZPS, 5-point method)];
- •4. Expected survival >= 3 months;
- •5. Subject has a measurable target lesion examined by CT or MRI or PET-CT according to RECIST 1.1 criteria;
- •6. Signed the informed consent.
排除标准
- •1. Prepare for tumor immunotherapy and/or radiation therapy;
- •3. Patients with unstable brain metastases with cerebral edema;
- •4. Pregnant and lactating women and patients of reproductive age who do not want to take contraceptive measures;
- •5. Patients with mental illness or low intelligence;
- •6. Known allergy or intolerance to the study drug;
- •(1) Absolute neutrophils count (ANC) < 1.5 x 10^9/L, or platelet count (PLT) < 100 x 10^9/L, or hemoglobin < 90g/L; Blood transfusion was not allowed within 1 week before enrollment; 2. Serum total bilirubin > 1.5 x upper normal limit (ULN); AST(SGOT)/ALT(SGPT) > 2.5 x upper normal limit, >= 5 times upper normal limit if it is clearly attributed to liver metastasis; 3. Creatinine clearance rate < 50mL/min; Clinically significant electrolyte abnormalities; Urine protein test results >= 2+ or urine protein volume >= 1.0g/24h); Cardiac function grade III-IV (NYHA grading).
- •8. Has been in the past 4 weeks or is participating in other clinical trials;
- •9. Failure to recover from the toxicity of previous anticancer therapy (NCICTCCAE > grade 1, including oxaliplatin induced hair loss and neurotoxicity <= 2), failure to fully recover from previous surgery, or the duration of previous anticancer therapy or surgery is less than 4 weeks;
- •10. Subjects with clinically detectable second primary malignancies or other malignancies within the last 5 years at the time of enrollment (excluding adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix);
- •11. Clinically uncontrolled active infections, such as acute pneumonia, active hepatitis B, hepatitis B, etc. (previous history of hepatitis B virus infection, with or without drug control, HBV DNA >= 10^4 copies /ml or >= 2000IU/ ml);
- •12. Difficulty swallowing or malabsorption of medication;
- •13. Coagulation dysfunction, bleeding tendency or obvious bleeding history after receiving anticoagulant therapy;
- •14. Arterial/venous thromboembolic events, such as cerebrovascular accidents (including transient ischemic attack), occurred within 12 months prior to initial treatment.
- •15. Acute myocardial infarction, acute coronary syndrome, or coronary bypass grafting within 6 months prior to initial treatment;
- •16. A fracture or wound remains unhealed for a long time;
- •17. Patients with brain metastases, digestive tract diseases, peritoneal and mesenteric diseases, and nervous system diseases that can cause non-chemotherapy-related nausea and vomiting;
- •18. Nausea and vomiting within 24 hours before chemotherapy;
- •19. Complications include one of the following symptoms: uncontrolled hypertension (uncontrolled hypertension with monotherapy, i.e., systolic blood pressure > 140mmHg or diastolic blood pressure >90mmHg after monotherapy), coronary artery disease, arrhythmias, and heart failure.
研究者
相似试验
尚未招募
不适用
Evidence-based capacity building project of traditional Chinese medicine for prevention and treatment of type 2 diabetes --A multi-center randomized controlled clinical study on the treatment of newly diagnosed type 2 diabetes mellitus with damp-heat syndrome by Huashi Jiangzhuo recipetype 2 diabetes mellitusITMCTR2200006156Guang'anmen Hospital of China Academy of Chinese Medical Sciences
招募中
不适用
Clinical efficacy evaluation for several diseases based on real world clinical data centerHematopathy, cardiovascular disease, nephropathy, COPD, chronic osteoarthritis, malignant tumorITMCTR2100004808The First Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine
尚未招募
不适用
A study for the standardization of TCM rehabilitation program for post-stroke cognitive impairmentpost-stroke cognitive impairmentITMCTR1900002795The First Affiliated Hospital of He'nan University of Chinese Medicine
尚未招募
1 期
Traditional Chinese medicine (TCM) collaborative care for patients with Poststroke depression: a randomized controlled trialPoststroke depressionITMCTR2000002968Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
招募中
1 期
Cohort study on the characteristics of TCM constitution and adverse metabolic reactions of antipsychotic drugs in patients with first-episode schizophreniaschizophreniaITMCTR2100004650Hangzhou Seventh Peoples Hospital