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Zuojinwan Combined With Chemotherapy and Cetuximab for Advanced Colorectal Cancer: a Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

Zuojinwan Combined With Chemotherapy and Cetuximab for Advanced Colorectal Cancer: a Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036686
Enrollment
Unknown
Registered
2020-08-24
Start date
2020-10-01
Completion date
Unknown
Last updated
2021-01-11

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

Conditions

colorectal cancer

Interventions

Sponsors

Shuguang Hospital, Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients who are diagnosed as colorectal cancer by pathology, cytology or imaging, and whose histological type is carcinoma, mucinous adenocarcinoma, signet ring cell carcinoma; 2. Colorectal cancer patients with stage IV according to AJCC staging; 3. RAS, BRAF wild-type, advanced unresectable colorectal cancer patients receiving chemotherapy combined with cetuximab; 4. After PET-CT, CT, MRI, bone scan and other imaging examinations, there is at least one measurable lesion; 5. TCM syndrome differentiation belongs to the syndrome of liver fire offending the stomach; 6. 18 years old = 60 points; 8. Estimated survival time >= 3 months; 9. Blood routine, liver function, kidney function, and heart function are generally normal, in line with chemotherapy indications; 10. Have good compliance and sign informed consent to cooperate with this research.

Exclusion criteria

Exclusion criteria: 1. Combined with other primary tumors; 2. Patients with severe cardiovascular and cerebrovascular diseases or severe mental illness; 3. Those who have used chemotherapy or Chinese medicine for less than 2 cycles; 4. Patients with active tuberculosis or infection; 5. Those who are unable to take drugs orally; 6. Those who have poor compliance and cannot complete the research; 7. Those who have participated in other clinical trials in the past month. 8. Women during pregnancy or breastfeeding.

Design outcomes

Primary

MeasureTime frame
progression free survival;

Secondary

MeasureTime frame
overall survival;Quality of Life;

Countries

China

Contacts

Public ContactWang Yan
wangyan_sg@126.com+86 17717074405

Outcome results

None listed

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