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A multicenter study on the efficacy and influencing factors of Insect Compound Particle in the treatment of MMR related stage III colorectal cancer

Phase 1
Conditions
colorectal cancer
Registration Number
ITMCTR2000003835
Lead Sponsor
Shanghai Municipal Hospital of Traditional Chinese Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

(1) According to the above diagnostic criteria, stage III colorectal cancer was diagnosed;
(2) They agreed to accept radical operation, and were clinically diagnosed as tn1-2m0 after consultation, physical examination, laboratory examination and imaging examination;
(3) Agree to collect colorectal cancer tissue samples, and agreed to carry out pathological test, MMR, RAS, malta1, NF2 gene detection and Merlin protein expression;
(4) We agreed to collect peripheral blood for metabonomics analysis;
(5) Aged >=18 years old;
(6) The ECoG of the patients with an estimated survival time of more than 6 months was less than 2;
(7) They agreed to be followed up;
(8) The follow-up and clinical data were complete;
(9) Those who voluntarily sign informed consent.

Exclusion Criteria

(1) Complicated with other primary malignant tumor;
(2) Complicated with serious heart, brain, liver, kidney disease, electrolyte abnormality or mental illness;
(3) Patients who are allergic to the drugs used in this study or their ingredients;
(4) Pregnancy, lactation or planned pregnancy;
(5) With serious or uncontrollable infections;
(6) Those who took other traditional Chinese medicine or participated in other clinical trials in recent 2 weeks.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
DFS;
Secondary Outcome Measures
NameTimeMethod
TCM symptom score scale;OS;Quality of life scale;Safety-related physical and chemical indicators;
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