A clinical study of traditional Chinese medicine prolonging the survival of advanced gastric cancer patients by regulating the immunosuppressive cell population: A study protocol for a multicenter, randomized controlled trail
- Conditions
- Gastric Cancer
- Registration Number
- ITMCTR1900002830
- Lead Sponsor
- Jiangsu Province Hospital of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1. Patients with pathological diagnosis of gastric cancer;
2. Patients with histologically or cytologically confirmed stage III after resection or IV,who cannot undergo radical surgery or postoperative recurrence and metastasis;
3. KPS scores >60;
4. Aged from 18 to 75 years old;
5. Patients with life expectancy of at least 6 months;
6. Patients who provide written informed conset to participate in the study according to the GCP criteria;
7. Childbearing age women whose urine pregnancy test is negative within 7 days before enrollment. All the patients and their spouse should abstinence all the time or at fixed periods during this trail or take at least 2 effective contraceptives. Abstinence or contraceptives still need to be used for 2 years after the trail.
1. Patients who is unable to swallow oral medications(including with digestive tract obstruction and jejunostomy;
2. Patients with symptomatic brain metastasis or mental disorder;
3. Patients who has severe cardiovascular disease, hepatopathy, kidney disease or blood disease;
4. Patients whose laboratory examination before enrollment is abnormal: Blood routine examination: ANC< 2.0x10^9/L, Hb< 90g/L, PLT <80x10^9/L, Renal function: Cr>1.5 UNL, CCr<50ml/min, liver function:TBil>1.5 UNL, ALT(SGPT) and AST(SGOT) >1.5×UNL;
5. Patients who are pregnant, nursing;
6. Patients who are substance abuse,or with clinical ,mental and social features which is interference for the study and informed consent.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1 year survival rate;progression free survival;
- Secondary Outcome Measures
Name Time Method TCM sydrome score;immunosuppressive cell population;Quality of life;tumor marker;cytokines;piper fatigue scale;objective remission rate;overall survival;