A randomized, controlled, single-center clinical study of Xiaoyan Decoction in combination with Durvalumab in the treatment of unresectable advanced NSCLC after radiotherapy and chemotherapy

Phase 1

Recruiting

• Conditions: lung cancer

• Registration Number: ITMCTR2100004486
• Lead Sponsor: The First Teaching Hospital of Tianjin 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. Age: 18 ~ 75 years old, male or female;
2. Patients with advanced non-small cell lung cancer diagnosed histomathologically and/or cytologically (Note: unresectable non-small cell lung cancer: A, tumor involving the heart, large blood vessels, trachea, or adjacent organs.B. Patients with multi-station or large lymph node metastases should be considered unresectable;It should be considered in conjunction with other factors, including age, PS score and response to treatment.C. Patients with supraclavicular lymph node involvement should be considered unresectable.D. Patients with distant metastasis (including non-regional lymph nodes) are unresectable.
3. Patients who have received at least previous radiotherapy and chemotherapy, and whose driver gene epidermal growth factor-receptor (EGFR) and anaplasticlymphoma kinase (ALK) related to lung cancer are wild-type;
4. ECOG PS: 0-2 points
5. Life expectancy, at least for 3 months and qi deficiency syndrome differentiation of traditional Chinese medicine to poison and blood stasis in patients with advanced non-small cell lung cancer ((differentiation) syndromes of traditional Chinese medicine standard reference set by the nature of Chinese society for the study of combining traditional Chinese and western medicine professional committee of standard of deficiency syndrome differentiation, Chinese society for the study of combining traditional Chinese and western medicine professional committee of blood stasis syndrome of blood stasis syndrome diagnostic standard , the state administration of traditional Chinese medicine published in 1994 standard of diagnosis of disease and curative effect of traditional Chinese medicine, standard of syndrome differentiation of traditional Chinese medicine).
Syndrome of Qi deficiency: fatigue, low voice, loss of appetite, fat tongue, weak pulse;
Symptoms of heat toxicity: red face, fever, sore swelling, red tongue, yellow moss, strong pulse;
Symptoms of blood stasis: rough skin, subcutaneous ecchymosis, pain at fixed sites, numbness of limbs, dark purple tongue or tongue ecchymosis, astringent pulse, no pulse or heavy string, late string.
At least one of the above syndromes is required for the diagnosis of Qi deficiency and poison stasis syndrome.
6. Damage caused by other treatments has been recovered (NCI-CTCAE 4.0 <= 1);
The interval of receiving nitrosourea or mitomycin was >= 6 weeks.Receiving other cytotoxic drugs, radiotherapy or surgery >= 4 weeks;
7. The major organs are functioning normally, that is, they meet the following criteria:
(1) Routine blood examination standards should be met (no blood transfusion and blood products within 14 days, no G-CSF and other hematopoietic stimulating factors have been used to correct):
A. HB 90 g/L or higher;
B. the ANC acuity 1.5 x 109 / L;
C. PLT acuity 80 x 109 / L;
(2) Biochemical examination shall meet the following standards:
A. TBIL < 1.5 ULN.
B. ALT and AST<2.5ULN, but < 5ULN in patients with liver metastasis;
C. Serum Cr <= 1.25ULN or endogenous creatinine clearance > 45 mL /min (Cockcroft-Gault formula);
8. Durvalumab can be treated with an attending physician's plan;
9. Women of child-bearing age must have used reliable contraceptives or had a pregnancy test (serum or urine) within 7 days prior to enrolment, be negative, and be willing to use appropriate methods of contraception during the trial and 8 weeks after the last administration of the test drug.For men, consent must

Exclusion Criteria

1. Participated in other drug clinical trials within 4 weeks prior to study commencement;Or patients who have previously used anti-PD-1 antibody, anti-CTLA-4 antibody, TCR-T, CAR-T and other immunotherapy for disease progression;
2. The persistence of toxicity associated with previous chemotherapy and/or radiotherapy;
3. Have any active autoimmune diseases or a history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaritis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after hormone replacement therapy);Patients with complete remission of childhood asthma without any intervention or vitiligo as adults were included, but patients requiring medical intervention with bronchodilators were not included;Congenital or acquired immunodeficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA >= 500 IU/ mL), hepatitis C (HCV antibody positive and HCV-RNA above the detection limit of the assay method) or co-infection with hepatitis B and hepatitis C;
4. Use of immunosuppressive drugs within 14 days prior to initial study drug use, excluding nasal and inhaled corticosteroids or systemic corticosteroids at physiological doses (i.e., not more than 10 mg prednisone/day or other corticosteroids at pharmacological doses equivalent);
5. Live attenuated vaccine injection within 4 weeks prior to initial administration or planned for the study period;
6. Within 4 weeks after the last systemic cytotoxic drug therapy or radiotherapy therapy or currently using other anti-tumor drugs;
7. Suffered from other malignant tumors in the past 3 years;
8. Uncontrolled hypertension (systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg, despite optimal medication);
9. Patients with grade II or above myocardial ischemia or myocardial infarction and poorly controlled arrhythmias (including QTc interval >= 450ms for males and >= 470ms for females). According to NYHA standard, grade III ~ ? cardiac insufficiency, or heart colour to exceed examination prompt left ventricular ejection fraction (LVEF) < 50% into the group of the first six months happened myocardial infarction, heart failure, New York heart association class II or above has not been control angina pectoris, out of control of severe ventricular arrhythmia, clinical significance of cardiac disease, or abnormal electrocardiogram (ecg) indicate that acute ischemia or active conduction system;
10. Severe infection (such as the need for intravenous antibiotics, antifungal or antiviral drugs) within 4 weeks prior to initial administration, or unexplained fever during screening/prior to initial administration, >38.5 degrees C;
11. Abnormal coagulation function (INR >1.5 or prothrombin time (PT) BBB>N +4 s or APTT BBB2 1>LN), bleeding tendency or receiving thrombolytic or anticoagulant therapy; Note: Under the premise of INR <= 1.5, low dose heparin (daily dose of adult 0.6 thousand ~ 12 thousand U) or low dose aspirin (daily dose of 100 mg or less) are allowed for prophylactic purposes.
12. Routine urine indicated that urine protein >= ++, or confirmed that 24-hour urine protein volume >= 1.0g;
13. Clinically significant blood spilt or hemoptysis greater than half teaspoon (2.5ml) or more per day within 2 months before enrollment;Or bleeding symptoms of significant clinical significance or a definite bleeding tendency, such as gastrointestinal bleeding, bleeding gastri

Study & Design

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

Primary Outcome Measures

Name	Time	Method
DCR;ORR;