A randomized, controlled, double-blind trial for the efficacy of Xianglianwan in the immunotherapy of advanced malignant tumors

Phase 1

Recruiting

• Conditions: malignant tumors

• Registration Number: ITMCTR1900002635
• Lead Sponsor: Shanghai TCM-integrated Hospital, Shanghai University of TCM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. in line with the diagnostic criteria for malignant tumors, pathological examination to confirm the diagnosis, TNM stage IV;
2. receiving PD-1/L1 monoclonal antibody, CTLA-4 antibody, or immunological combination therapy;
3. aged 18-80 years old, male or female;
4. KPS score >=60 points, estimated survival >=3 months.

Exclusion Criteria

1. combined with severe primary diseases such as cardiovascular and cerebrovascular diseases, as well as mental illness;
2. In the course of clinical research, the compliance is poor and the data is incomplete;
3. the diagnosis is not clear;
4. subjects who have not performed the provisions of this protocol;
5. Observing subjects who are incomplete and unable to evaluate the test results and side effects;
6. participated in other clinical trials in the past 3 months;
7. have received other immune-related treatments or Chinese medicine treatments that may affect immune function;
8. During the course of medication, patients who are suffering from other diseases due to non-pharmaceutical factors cannot continue to complete immunotherapy;
9. ECOG 3~4;
10. used antibiotics, systemic corticosteroids (or less than 10 mg/day of prednisone) and other immunosuppressants within 1 month prior to enrollment;
11. with inflammatory bowel disease, radiation enteritis, rheumatism and other diseases;
12. Other serious comorbidities.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intestinal flora;PFS;

Secondary Outcome Measures

Name	Time	Method
D-LA;T cell subset;DAO;Hormone use;OS;ECOG score;ET;KPS score;Cytokines;frequency, grading and time of occurrence of irAEs;TCM syndrome;