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From the perspective of spleen treatment, to explore the clinical and mechanistic research of spleen strengthening and tumor elimination formula in the treatment of advanced cholangiocarcinoma

From the perspective of spleen treatment, to explore the clinical and mechanistic research of spleen strengthening and tumor elimination formula in the treatment of advanced cholangiocarcinoma

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000367
Enrollment
Unknown
Registered
2024-09-03
Start date
2024-06-06
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Cholangiocarcinoma

Interventions

Traditional Chinese medicine + chemotherapy group:Spleen and tumor decoction + gemcitabine + cisplatin/oxaliplatin
Chemotherapy group:Gemcitabine + cisplatin/oxaliplatin

Sponsors

HENAN PROVINCE HOSPITAL OF TCM
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Age> 18 years old, gender is not limited; (2) Patients with a clear pathological diagnosis and clinical stage II-I; (3) No anti-tumor therapy and agreement to treatment within 2 weeks prior to enrollment; (4) KPS score >60 points: (5) The estimated survival time is greater than 3 months; (6) Patients without serious heart, lung, liver, kidney, brain and other organ diseases; (7) Obtain informed consent signed by the subject or his/her legal representative; (8) Those who can cooperate with the completion of research procedures and follow-up examinations.

Exclusion criteria

Exclusion criteria: (1) Currently receiving chemoradiotherapy, targeted therapy, etc.; (2) Investigators who are participating in other clinical trials; (3) Those with serious diseases of the heart, brain, lungs, liver, kidneys and hematopoietic system; (4) Factors affecting the efficacy such as failure to use drugs as prescribed, inability to determine the efficacy or incomplete data; (5) Those with allergies or allergies to the test drug; (6) Pregnant or lactating women and patients with mental illness; (7) Those who cannot cooperate with the completion of this trial.

Design outcomes

Primary

MeasureTime frame
Immunological Indicators;therapeutic efficacy indicators;

Secondary

MeasureTime frame
TCM Symptom Score;transcriptome analysis;Quality of Life Score;

Countries

China

Contacts

Public ContactZhizhongGuo

HENAN PROVINCE HOSPITAL OF TCM

fangliao0525@163.com18603719119

Outcome results

None listed

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