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A Randomized Controlled Clinical Study for Traditional Chinese Medicine to Improve the Clinical Benefit Rate of Advanced Esophageal Cancer

Phase 1
Conditions
Esophageal cancer
M8000/3
Registration Number
ITMCTR2000003504
Lead Sponsor
Henan Province Hospital of TCM
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

1. Meet the diagnostic criteria of Chinese and Western medicine;
2. Esophageal cancer patients who cannot undergo surgery, radiotherapy, chemotherapy or disease progression after chemotherapy;
3. Gender and age are not limited;
4. The estimated survival time was more than 20 days;
5. KPS score >= 40;
6. Those who could take traditional Chinese medicine orally before treatment;
7. The patient voluntarily signs the informed consent with the informed consent.

Exclusion Criteria

1. Pregnant and lactating women;
2. Patients with mental illness who are difficult to cooperate with treatment;
3. Allergy to drugs;
4. Patients with severe liver, kidney, heart and hematopoietic system diseases;
5. There was no definite pathological diagnosis;
6. Have participated in other clinical research;
7. According to the researcher's judgment, other diseases or conditions that reduce the possibility of enrollment or complicate the enrollment, such as frequent changes in working environment and unstable living environment and other situations that are likely to cause patients to loss to follow-up.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
TCM syndrome score;Survival rate of 42 days;KPS score;42 days quality of life;
Secondary Outcome Measures
NameTimeMethod
Serum tumor markers (CEA, SCC, CA153, CA125, CA199);Safety indicator;T lymphocyte subsets (CD3, CD4, CD8, CD16, CD56), regulatory T cells (CD4 +, CD25 +, Foxp3);Remission of local lesions;
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