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A Non-Inferiority Randomized Controlled Trial of Tuteng Fang Combined with Long-Interval Chemotherapy in the Treatment of Advanced Colorectal Cancer

A Non-Inferiority Randomized Controlled Trial of Tuteng Fang Combined with Long-Interval Chemotherapy in the Treatment of Advanced Colorectal Cancer

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043996
Enrollment
Unknown
Registered
2021-03-06
Start date
2021-06-01
Completion date
Unknown
Last updated
2025-03-17

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

Conditions

colorectal cancer

Interventions

Combined group:1.Traditional Chinese Medicine therapy: Tusizi (Cuscuta chinensis Lam.) , Tengligen (Actinidia arguta ), Sangjisheng (Taxillus chiensis (DC.) Danser) , Qianshi(Euryale ferox), Baihuashe
Capecitabine at a dose of 1000 mg/m2, taken orally twice a day from day 1 to day 14. The interval between each chemotherapy cycle is 21 days, with a cycle lasting 35 days, and the treatment continues
Control group:Chemotherapy with the XELOX regimen alone is carried out. The interval between each chemotherapy cycle is 7 days, with one cycle lasting 21 days. The treatment continues for 6 cycles. Re

Sponsors

Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Patients with stage IV colorectal cancer confirmed according to the diagnostic criteria outlined in the Chinese Colorectal Cancer Diagnosis and Treatment Guidelines (2017 Edition); 2. No radical surgery, radiotherapy, chemotherapy, or other treatments were received after the diagnosis of stage IV disease; 3. Karnofsky Performance Score (KPS) > 60 points; 4. Age >18 years with no gender restrictions; 5. Expected survival time >= 3 months; 6. Patients provided informed consent and are willing to undergo follow-up; 7. Complete baseline patient information is available.

Exclusion criteria

Exclusion criteria: 1. Patients with BRAF, RAS, or VEGF gene mutations; 2. Patients with a history of mental illness; 3. Patients with hepatic or renal insufficiency; 4. Patients with concurrent cancer; Those who meet any of the above criteria will be excluded.

Design outcomes

Primary

MeasureTime frame
Progression-Free Survival;

Secondary

MeasureTime frame
Disease Control Rate;Karnofsky Performance Status;Traditional Chinese Medicine syndrome score;

Countries

China

Contacts

Public ContactFenggang Hou

Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine

fghou555@126.com+86 134 0211 0405

Outcome results

None listed

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