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The research of Sanghuangporusbaumii tablets on immune regulation of colorectal cancer patients after chemotherapy

Registration number：

ITMCTR2100005160

Date of Last Refreshed on：

2021-08-09

Date of Registration：

2021-08-09

Registration Status：

Prospective registration

Public title：

The research of Sanghuangporusbaumii tablets on immune regulation of colorectal cancer patients after chemotherapy

English Acronym：

Scientific title：

The research of Sanghuangporusbaumii tablets on immune regulation of colorectal cancer patients after chemotherapy

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

ChiCTR2100049792 ; ChiMCTR2100005160

Applicant：

Wang Ting

Study leader：

Li Ping

Applicant telephone：

+86 18110923277

Study leader's telephone：

+86 13965112719

Applicant Fax：

Study leader's fax：

Applicant E-mail：

wangting921204@163.com

Study leader's E-mail：

1964liping@sina.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

120 Wanshui Road, High Tech Zone,Hefei, Anhui, China

Study leader's address：

120 Wanshui Road, High Tech Zone,Hefei, Anhui, China

Applicant postcode：

Study leader's postcode：

Applicant's institution：

The First Affiliated Hospital of Anhui Medical University

Approved by ethic committee：

Approved No. of ethic committee：

PJ2020-03-50

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of clinical medical research in the First Affiliated Hospital of Anhui Medical University

Date of approved by ethic committee：

2020/12/27 0:00:00

Contact Name of the ethic committee：

Zhou Tao

Contact Address of the ethic committee：

218 Jixi Road, Shushan District, Hefei, Anhui, China

Contact phone of the ethic committee：

Contact email of the ethic committee：

Primary sponsor：

The First Affiliated Hospital of Anhui Medical University

Primary sponsor's address：

120 Wanshui Road, High Tech Zone,Hefei, Anhui, China

Secondary sponsor：

Country：

China

Province：

Anhui

City：

Hefei

Institution
hospital：

The First Affiliated Hospital of Anhui Medical University

Address：

218 Jixi Road, Shushan District

Source(s) of funding：

Provincial financial special funds of Anhui Province

Target disease：

Colorectal cancer

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Post-marketing clinical trial

Objectives of Study：

To evaluate the efficacy and safety of Sanghuangporusbaumii tablets for immune regulation in patients with immunocompromised colorectal cancer after chemotherapy.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

1. Colorectal cancer patients (TNM stage III-IV); 2. Those who are suitable for chemotherapy (the chemotherapy regimen is not limited), and patients with impaired immunity after chemotherapy (the ratio of CD4/CD8 in peripheral blood <1.4); 3. Age 18~75 years old, gender is not limited; 4. ECOG score 0~1 points; 5. Expected survival > 6 months.

Exclusion criteria：

1. Those with primary immunodeficiency disease and other serious infectious diseases, 2. Patients who have received immunomodulatory therapy before; 3. Patients with abnormal blood routine, liver function and renal function; 4. Pregnant or lactating women, and persons with mental disorders; 5. Those with poor compliance are easily lost to the follow-up.

Study execute time：

From 2021-01-01

To      2023-12-31

Recruiting time：

From 2021-08-01

To      2023-12-31

Interventions：

125

Group：

Experimental group

Sample size：

Intervention：

OralSanghuangporusbaumii tablets (15g per person per day, 200ml of boiling water for 15min, filter out the supernatant, then 200ml of boiling water for 15min, filter out the supernatant, combine the two supernatants for oral use), continuous treatment for 2 weeks

Intervention code：

125

Group：

Positive control group

Sample size：

Intervention：

The patient was treated with thymofaxine (1.6 mg subcutaneously twice a week) for 2 consecutive weeks.

Intervention code：

Total sample size ： 250

Countries of recruitment
and research settings：

Country：

China

Province：

Anhui

City：

Hefei

Institution/hospital：

The First Affiliated Hospital of Anhui Medical University

Level of the institution：

Tertiary A

Outcomes：

Outcome：

Adverse reactions

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Immunocompromised control ratio

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Symptom score

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Immune function index

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

Blood

Tissue：

Fate of sample 

Destruction after use

Note：

Recruiting

18
Min age years
75
Max age years

Recruiting status：

Participant age：

Gender：

Both

Randomization Procedure (please state who generates the random number sequence and by what method)：

Non-project group members were randomly selected by random number table and divided into experimental group and control group according to the smallest to the largest random number.

Blinding：

IPD sharing：

Yes

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

The data will be released with six months after the trial was completed

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

This project is designed with a clinical-specific CRF table forcase record and an electronic collection and management system, with a dedicated person for paper records, and all the above-mentioned information is kept at the investigator's office

Data Managemen Committee：

Not yet

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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