Clinical study of astragalus polysaccharide Injection combined with Carrelizumab and Apatinib in the treatment of lung cancer patients with qi and Yin deficiency and its mechanism of enhancing efficacy and reducing toxicity

Phase 1

Recruiting

• Conditions: ung cancer

• Registration Number: ITMCTR2100004691
• Lead Sponsor: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

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

To be enrolled in this study, patients must meet all the following inclusion criteria:
1) Aged 18-80 years, male or female;
2) With at least one measurable single diameter lesion which could be clearly diagnosed by pathology (RECIST standard version 1.1);
3) ECOG score 0~2;
4) The expected survival time is not less than 12 weeks;
5) The main organs function normally:
Blood routine examination shall meet (no blood transfusion within 14 days, no use of hematopoietic factors and no use of medication correction): ANC >= 1.5 x 10^9/L; HB >= 90 g/L; PLT >= 100 x 10^9/L;
Biochemical examination shall meet the following standards: TBIL <= 1.5ULN; ALT and AST <= 2.5ULn ( <= 5ULN if abnormal liver function is caused by liver metastasis); serum creatinine sCr <= 1.5ULN, endogenous creatinine clearance rate >= 50ml/min (Cockcroft-Gault formula);
The coagulation function: INR <= 1.5 and APTT <= 1.5ULN; heart color doppler ultrasound LVEF >= 50%.
6) Women of childbearing age must have a pregnancy test (serum or urine) that is negative within 7 days of enrollment, and be willing to use an appropriate method of contraception during the test and 8 weeks after the last dose of the test drug;
7) Able to swallow oral medication;
8) The patient's syndrome belongs to deficiency of qi and Yin;
9) Subjects willing to participate in the study, sign the informed consent form, have good compliance and cooperate with the follow-up.

Exclusion Criteria

Patients with any of the following conditions shall not be enrolled in this study:
1) Participated in other drug clinical trials within 4 weeks before the start of the study;
2) Have any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after hormone replacement therapy)); Childhood asthma was in complete remission and adult patients without any intervention or vitiligo could be included, but patients requiring medical intervention with bronchodilators could not be included.
3) Congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA >= 500 IU/ml), hepatitis C (hepatitis C antibody positive and HCV-RNA higher than the detection limit for analytical methods) or co-infection with hepatitis B and Hepatitis C;
4) Immunosuppressive drugs were administered within 14 days prior to the first use of the study drug, excluding nasal spray and inhaled corticosteroids or systemic steroids at physiological doses (i.e., not exceeding 10 mg/ day of prednisone or other corticosteroids at the same physiologic dose);
5) Live attenuated vaccine were administered within 4 weeks before the first administration or during the study period;
6) Other anti-tumor drugs are being used within 4 weeks after the last systemic cytotoxic drug therapy or radiotherapy drug therapy;
7) With other malignant tumors in the past 3 years;
8) Uncontrolled hypertension (systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg, despite the best medication);
9) Patients with grade II or above myocardial ischemia or infarction and poorly controlled arrhythmias (including QTc interphase >= 450ms in males and >= 470ms in females).According to NYHA standard, grade III ~ ? cardiac insufficiency, or heart ultrasound:left ventricular ejection fraction (LVEF) < 50%; A history of myocardial infarction, New York Heart Association grade II or higher heart failure, uncontrolled angina, uncontrolled severe ventricular arrhythmia, clinically significant pericardial disease, or electrocardiogram indicating acute ischemia or abnormal activity of the conduction system within 6 months prior to enrollment.
10) severe infection (e.g., intravenous antibiotics, antifungal or antiviral drugs required) within 4 weeks prior to first administration, or unexplained fever of >38.5°C during screening/prior to first administration;
11) abnormal coagulation function (INR >1.5 or prothrombin time (PT) > ULN+4 seconds or APTT > 1.5uln), bleeding tendency or receiving thrombolytic or anticoagulant therapy; Note: Under the condition that the international standard ratio of prothrombin time (INR) <= 1.5, low-dose heparin (daily dosage for adults ranges from 66,000 to 12,000 U) or low-dose aspirin (daily dosage <= 100 mg) is allowed for preventive purposes.
12) Urine routine suggested urinary protein >= ++, or confirmed 24-hour urinary protein >= 1.0g;
13) Clinically significant cough blood or daily hemoptysis greater than half a teaspoon (2.5ml) or more within 2 months before enrollment;Or bleeding symptoms of significant clinical significance or a obvious clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, stool occult blood ++ or above at baseline, or with vasculitis;
14) arteriovenous thrombosis events o

Study & Design

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

Primary Outcome Measures

Name	Time	Method
PFS;

Secondary Outcome Measures

Name	Time	Method
PD;FACT-LQoL;ORR;