Anlotinib Capsules in the Treatment for IPF/PF-ILDs

Inclusion Criteria:

1. The participants voluntarily joined the study and signed an informed consent form.They showed good compliance throughout the study.

2. The study includes individuals aged 40-85 years old, of any gender, with an expectedlifespan of over 1 year.

3. Subjects who meet either of the following two criteria: a. HRCT results confirmingIPF diagnosis within the past 5 years and HRCT results within the past 12 monthsshowing a range of parenchymal fibrotic changes between ≥10% and <50%, with lessthan 25% honeycombing change in the lung, and no other facilitating factors (e.g.asbestos exposure, allergic pneumonia, systemic sclerosis, rheumatoid arthritis) asdetailed in Annex 1A. b. PF-ILDs: Patients with characteristics of fibrotic lungdisease (see Annex 1B), and at least one of the following diagnostic criteria ismet: i. Relative decline in FVC% predicted by ≥10% within 6 months; ii. Relativedecline in FVC% predicted by ≥5-10% with worsening respiratory symptoms, or anincrease in the degree of fibrosis on chest HRCT; ii. Worsening respiratory symptomscombined with an increase in the degree of fibrosis on chest HRCT;

4. Carbon monoxide diffusion capacity (DLco) (corrected for hemoglobin) between 30% and 80% of predicted value;

5. Force vital capacity (FVC) ≥ 45% predicted;

6. The 6MWT distance is ≥ 150 meters

7. Arterial partial pressure of oxygen (PaO2) ≥ 60 mmHg (measured at sea levelatmospheric pressure, at rest, and breathing room air)

8. "Major organ functions are good, and meet the following criteria: a. Standard bloodroutine examination (not corrected by blood transfusion or hematopoietic growthfactor drugs in the past 7 days): hemoglobin (HGB) ≥ 90 g/L; absolute neutrophilcount (NEUT) ≥ 1.5 × 10^9/L; platelet count (PLT) ≥ 90 × 10^9/L; b. Biochemicalexamination should meet the following criteria: total bilirubin (TBL) ≤ 1.5 timesthe upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartateaminotransferase (AST) ≤ 2.5 × ULN; serum creatinine (Cr) ≤ 1.5 × ULN or creatinineclearance rate (Ccr) ≥ 60 ml/min; c. Coagulation function or thyroid functionexamination should meet the following criteria: prothrombin time (PT), activatedpartial thromboplastin time (APTT), international normalized ratio (NR) ≤ 1.5 × ULN (not receiving anticoagulation therapy) or stable use of anticoagulants in the 2weeks before enrollment; d. Thyroid-stimulating hormone (TSH) ≤ ULN after standardtreatment; if abnormal, T3 and T4 levels should be investigated and can be enrolledif T3 and T4 levels are normal. e. Echocardiography evaluation: Left ventricular ejection fraction (LVEF) ≥50%

9. Female participants of childbearing potential must agree to use contraception (suchas intrauterine device, contraceptive pill, or condom) during the study and for 6months after the end of the study; must have a negative serum pregnancy test within 7 days before study entry and must not be lactating. Male participants must agree touse contraception during the study and for 6 months after the end of the study.

Exclusion Criteria:

1. Patients with acute exacerbation of PF/PF-ILDs.;

2. Multiple factors that affect oral medication (such as dysphagia, chronic diarrhea,and intestinal obstruction)

3. Received major surgical treatment, incisional biopsy, or significant traumaticinjury within 28 days prior to the start of the study treatment.

4. Long-standing non-healing wound or fracture.

5. Patients who have experienced thrombotic events, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, and cerebralinfarction), deep vein thrombosis, and pulmonary embolism, within the past 6 months,or those with other bleeding tendencies.

6. Subjects with any severe or uncontrolled comorbidities or undergoing immunotherapy,such as:

7. Blood pressure remains uncontrolled even after antihypertensive therapy (systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100mmHg); 2nd-degree myocardial ischemia or myocardial infarction, arrhythmia (includingQTc ≥450ms (men), QTc ≥470ms (women)) or 2nd-degree congestive heart failure (New York Heart Association (NYHA) classification); pulmonary or systemicinfections within 4 weeks before enrollment;

8. Severe pulmonary arterial hypertension (systolic pulmonary artery pressure (SPAP) ≥70mmHg);

9. Renal failure requiring hemodialysis or peritoneal dialysis;

10. History of immune deficiency diseases, including HIV-positive or other acquiredor congenital immune deficiency diseases, or history of organ transplantation;

11. Known clinically significant liver disease history, including viral hepatitis,known carriers of hepatitis B virus (HBV) must exclude active HBV infection,i.e., HBV DNA positive (>2500 copies/mL or >500IU/mL, and greater than theupper limit of normal); known hepatitis C virus (HCV) infection and positiveHCV RNA (>1×103 copies/mL), or other decompensated liver diseases;

12. Fasting blood glucose (FBG) >10mmol/L after administration of hypoglycemicdrugs (poor blood glucose control patients);

13. Urine routine test indicates urine protein ≥+, and 24-hour urine proteinquantitation is confirmed to be >1.0g.

14. Received high-dose steroids (e.g. prednisone >15mg/kg) within 1 month prior torandomization；

15. Use of immunosuppressants within 1 month prior to randomization after enrollment;

16. Long-term use (>1 week) of drugs such as amiodarone that may cause pulmonaryfibrosis prior to enrollment;

17. Received interferon, N-acetylcysteine (>1800mg), or other anti-fibrotic drugs within 1 month prior to randomization

18. Received treatment with nintedanib or pirfenidone for less than 28 days beforerandomization.

19. Participation in other drug trials within 3 months prior to randomization

20. The researcher considers any ineligible candidates.