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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

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

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100005329
Enrollment
Unknown
Registered
2021-04-14
Start date
2021-04-25
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colorectal cancer

Interventions

Sponsors

Department of Oncology, Affiliated Hospital of Traditional Chinese Medicine, Southwest Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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 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 = 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 = 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.

Design outcomes

Primary

MeasureTime frame
Adverse incident;Progression-free survival;

Countries

China

Contacts

Public ContactZhongming Yang

The Traditional Chinese Medicine Hospital Affiliated to Southwest

brainyang@swmu.edu.cn+86 13438010665

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026