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Clinical and mechanism study on maintenance treatment of advanced gastric cancer and colorectal cancer with Xinjialiang Fujianpi Yiqihe prescription

Clinical and mechanism study on maintenance treatment of advanced gastric cancer and colorectal cancer with Xinjialiang Fujianpi Yiqihe prescription

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000853
Enrollment
Unknown
Registered
2025-04-27
Start date
2024-11-15
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

gastric cancer colorectal cancer

Interventions

Control group:Capecitabine or tigio are given orally
Experimental group:Give Xinjialiang Fujianpi Yiqihe prescription Granules

Sponsors

Dongzhimen Hospital Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Experimental group: 1) In line with the western diagnostic criteria for advanced gastric cancer and colorectal cancer; (2) In line with TCM "spleen and stomach deficiency cold qi stagnation and blood stasis" syndrome differentiation standard; (3) The patient has completed the induction phase of treatment and the efficacy is evaluated as Complete response (CR) Partial response (PR) or Stable disease (SD) and is about to enter the maintenance treatment stage and is intolerant or does not accept Western drug maintenance treatment. Include patients with 1 or 2 interrupted cycles of western drug maintenance therapy; Age between 18 and 80 years old male and female; (5) The expected survival time is more than 6 months; 6) Kastler score =60 points; (7) Did not participate in other clinical practices for the purpose of clinical efficacy observation; 8) The subject gives informed consent and signs the informed consent voluntarily. Control group: 1) It met the western diagnostic criteria for advanced gastric cancer and colorectal cancer; 2) The patient had completed the induction phase of therapy the efficacy was evaluated as CR PR or SD and was about to enter the maintenance phase of therapy and could tolerate and receive capecitabine or Tegorgone maintenance therapy; Age between 18 and 80 years old male and female; 4) The expected survival time is more than 6 months; 5) Kastler score =60 points; 6) did not participate in other clinical practices for the purpose of clinical efficacy observation; 7) The subject gives informed consent and signs the informed consent voluntarily. Note: Patients in the control group who maintained 1 or 2 cycles of treatment interruption could be transferred to the trial group. Healthy subjects: 1) No chronic diseases in the past no abnormal blood urine stool routine blood biochemistry physical examination electrocardiogram and other examinations; 2) Between the ages of 18 and 80 both male and female; 3) The subject gives informed consent and signs the informed consent voluntarily.

Exclusion criteria

Exclusion criteria: 1) Patients with primary heart brain liver kidney and hematopoietic diseases or with serious tumor complications and complications; 2) Participating in other clinical practices for the purpose of evaluating clinical efficacy; Pregnant and lactating women; (4) People who are allergic or known to be allergic to certain drugs prescribed; 5) There is a mental system disease or cognitive dysfunction; 6) Can not take medication on time or poor compliance or can not adhere to the interviewer; 7) Other primary malignant tumors.

Design outcomes

Primary

MeasureTime frame
Disease control rate;

Secondary

MeasureTime frame
Progression-free survival;Metabolomic changes;Cytokines;Lymphocyte subset count;Transcriptomic changes;Simple fatigue scale;The symptoms and signs of "spleen and stomach deficiency and cold qi stagnation and blood stasis syndrome" are scored;Quality of life questionnaire;Symptom assessment scale;

Countries

China

Contacts

Public ContactLi Hou

Dongzhimen Hospital Beijing University of Chinese Medicine

houli1203@126.com13488695608

Outcome results

None listed

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