Efficacy and Safety of TQB2450 Injection Combined With Chemotherapy ± Anlotinib Hydrochloride Capsules for Advanced Endometrial Cancer or Sarcoma of Uterus.

Inclusion Criteria:

• The subjects voluntarily participated in this study, signed the informed consent,and had good compliance;

• Age: ≥18 years old (when signing the informed consent form); ECOG PS score: 0-1;expected survival period of more than 3 months; body mass index (BMI) > 18.5 andweight > 40kg;

• Who have not received first-line systemic anticancer therapy and are not suitablefor receiving treatment other than systemic treatment:

1. Group 1 and 2: Stage III/IV epithelial endometrial cancer (includingendometrioid carcinoma, non-endometrioid carcinoma, carcinosarcoma) confirmedby histopathology, and the subject also needs to meet one of the followingcategories:

2. Newly diagnosed subjects: there are still residual lesions visible onimaging after non-radical surgery;

3. Subjects with initial recurrence: if the subject received systemicplatinum-based adjuvant and/or neoadjuvant chemotherapy，and the recurrencetime is more than 6 months from the end of the last chemotherapy，then theprevious chemotherapy is allowed.

4. Group 3: Stage I-IV sarcoma of uterus, and the subject also needs to meet oneof the following categories:

5. Newly diagnosed/initial recurrence subject of high grade endometrialstromal sarcoma (ESS)、undifferentiated Uterine sarcoma (UUS) , uterineLeiomyosarcoma and adenosarcoma(uLMS) with sarcoma overgrowth (OS). Thedefinition of new diagnosis and initial recurrence is the same as above.

6. Low grade ESS, adenosarcoma without SO and other Uterine sarcoma withER+/PR+，the subjects who failed in antiestrogen treatment.

• According to the RECIST 1.1 criteria, there is at least one measurable lesion. Ifthe measurable lesion is located in the area of previous radiotherapy, it should beclearly defined as progressing state;

• Tumor tissue samples can be provided to detect MSI/MMR status or traceable testreports;

• The main organs function well and meet the following standards:

1. Blood routine examination standards (no blood transfusion within 7 days beforescreening, no correction with hematopoietic stimulating factor drugs):

2. Hemoglobin (HGB) ≥90 g/L;

3. The absolute value of neutrophils (NEUT)≥1.5×109/L;

4. Platelet count (PLT) ≥ 90 × 109/L;

5. The biochemical examination shall meet the following standards:

6. Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN);

7. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN. If accompanied by liver metastasis, ALT and AST≤5×ULN;

8. Serum creatinine (Cr) ≤ 1.5×ULN or creatinine clearance (Ccr) ≥ 60ml/min;

9. Serum albumin (ALB)>30g/L;

10. Urine routine examination standard: urine routine indicates urine protein <++;if urine protein ≥++, it is necessary to confirm the 24-hour urine proteinquantitative ≤1.0g;

11. Coagulation function or thyroid function tests should meet the followingcriteria:

12. Prothrombin time (PT), activated partial thromboplastin time (APTT),international normalized ratio (INR) ≤ 1.5×ULN (no anticoagulationtherapy);

13. Thyroid-stimulating hormone (TSH) ≤ ULN; T3 and T4 levels should beinvestigated if abnormal, and normal T3 and T4 levels can be selected.

14. Echocardiography assessment: Left ventricular ejection fraction (LVEF) ≥50%.

15. 12-lead electrocardiogram evaluation: QTc<470ms.

• Female subjects should agree that contraceptive measures (such as intrauterinedevices or condoms) must be used during the study period and within 6 months afterthe end of the study; the serum pregnancy test must be negative within 7 days beforestudy enrollment, and must be Non-lactating subjects.

Exclusion Criteria:

• Tumor disease and medical history:

1. Other malignant tumors that have occurred or are currently concurrently presentwithin 3 years. The following conditions were eligible for enrollment: othermalignancies treated with a single surgery, achieving 5 consecutive years ofdisease-free survival (DFS); cured cervical carcinoma in situ, non-melanomaskin cancer, and superficial bladder tumors [Ta ( non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor-infiltrating basement membrane)];

2. Pathologically suggested endometrial leiomyosarcoma, endometrial stromalsarcoma, undifferentiated uterine sarcoma or other high-grade sarcoma (Applicable to group 1 and 2), Pathologically suggested epithelial endometrialcancer or Carcinosarcoma (Applicable to group 3);

3. The presence of tumor thrombus, spinal cord compression caused by bonemetastases, brain metastases or cancerous meningitis;

4. Imaging (CT or MRI) shows that the tumor has invaded around important bloodvessels or the investigator judges that the tumor is very likely to invadeimportant blood vessels and cause fatal bleeding during the follow-up study;

5. Severe bone damage caused by tumor bone metastasis; including weight-bearingbone pathological fractures and spinal cord compression that occurred within 6months or predicted by the investigator to be likely to occur in the nearfuture;

6. Uncontrolled pleural effusion, pericardial effusion or ascites judged by theinvestigator that still needs repeated drainage.

• Previous anti-tumor therapy or concomitant medication (the washout period iscalculated from the end of the last treatment):

1. Previously received anti-angiogenesis drugs, related immunotherapy drugs forPD-1, PD-L1, CTLA-4;

2. Received drugs with immunomodulatory function, chemotherapy, radiotherapy,clinical trial drug treatment, traditional Chinese medicine or proprietaryChinese medicine with anti-tumor indications, or other anti-cancer therapywithin 4 weeks before receiving the study drug for the first time;

3. Received hormone therapy for endometrial cancer within 1 week before receivingthe first study drug treatment;

4. It is not satisfied that at least 5 half-lives have elapsed from the last useof the targeted drug to the first receiving of the study drug, if it is acombination drug, the drug with the longest half-life shall be calculated;

5. Those who have undergone major surgery, major surgical treatment, incisionalbiopsy, obvious traumatic injury, or have not recovered sufficiently fromprevious surgery in the judgment of the investigator within 3 weeks before thefirst treatment with the study drug, or are expected to be required during thestudy period. Major surgery;

6. The toxicity related to previous anti-tumor therapy has not recovered to CTCAE ≤ grade 1, except for alopecia and grade 2 peripheral neuropathy.

• Comorbid diseases and medical history:

1. History of liver-related diseases: a. Decompensated cirrhosis; b. Active orchronic hepatitis; c. Bleeding disease secondary to hepatic insufficiency.

2. Kidney related medical history: a. Renal failure requiring hemodialysis orperitoneal dialysis; b. Past or existing nephrotic syndrome, chronic nephritis.

3. Cardiovascular and cerebrovascular related medical history: a. Suffering fromepilepsy and requiring treatment; b. New York Heart Association class II-IVheart failure, second-degree or higher heart block, myocardial infarctionwithin the past 6 months or Arterial thrombosis events, unstable arrhythmia orunstable angina; c. Cerebrovascular accident, cerebral infarction, etc. within 6 months; d. If the treatment can adequately control blood pressure, the groupis allowed to enter the group; e. Past or current heart valve inflammation,endocarditis; f. Cardiovascular syncope, pathological ventricular arrhythmia.

4. Gastrointestinal-related medical history: a. Inability to take oralmedications; b. History of malabsorption syndrome or other diseases thatinterfere with gastrointestinal absorption; c. Active peptic ulcer or ulceratedlower gastrointestinal tract in the past 6 months Treated for inflammation; d.Persistent chronic diarrhea of grade 2 and above despite maximum medicaltreatment.

5. Lung-related medical history: a. History of idiopathic pulmonary fibrosis,organized pneumonia, drug-induced pneumonia, idiopathic pneumonia, or evidenceof active pneumonia found on chest CT scan during screening; b. Bronchodilatorrequired Medically intervened bronchial asthma; c. The clinical manifestationsare suspected to be tuberculosis, T-SPOT positive is judged by the investigatorto have tuberculosis infection or active tuberculosis within 1 year beforeenrollment;

6. Endocrine-related medical history: a. Poor control of type I or II diabetes; b.History of pituitary or adrenal dysfunction; c. Thyroid-stimulating hormone (TSH) > ULN, if T3 and T4 levels are normal, they can be enrolled.

7. Immune-related medical history: a. A history of immunodeficiency, including HIVpositive or other acquired and congenital immunodeficiency diseases; b. Organtransplantation planned or previously received, or hematopoietic stem cellsreceived within 60 days before the first dose Transplant, or have obvious hosttransplant response; c. Active autoimmune disease; d. Systemic or topicalimmunosuppressive or hormonal therapy is required to achieve immunosuppression,and continue to be used within 7 days before the first dose Glucocorticoids, orpatients who still need immunosuppressive drugs within 5 half-lives before thefirst dose.

8. Bleeding risk: a. Suffering from bleeding (hemoptysis), coagulation disease orusing warfarin, aspirin and other antiplatelet aggregation drugs (exceptaspirin ≤100 mg/d for prophylaxis); b. Regardless of severity, there are anysigns or history of bleeding constitution; c. within 4 weeks before the firstdose, any CTC AE ≥ grade 3 bleeding or bleeding events;

9. The patient has an active systemic infection or an excessive viral load;

10. Combining serious or not well-controlled diseases or diseases that theinvestigator determines may have a greater risk or affect the completion of thestudy, including but not limited to: a. History of clear neurological or mentaldisorders; b. Treponema pallidum specific antibody positive.

11. Those who have a history of drug abuse and cannot quit or have a history ofdrug use.

• Research and treatment related:

1. History of vaccination with live attenuated vaccine within 28 days before thestart of study treatment, inactivated vaccine within 7 days, or plannedvaccination during the study period;

2. Those who have a history of severe allergic diseases, severe drug allergies,and are known to be allergic to macromolecular protein preparations or TQB2450injection or any components in the prescription of Anlotinib capsules, theiradjuvants and similar drugs;

• Subjects with insufficient compliance or other reasons are not suitable forenrollment after the investigator's assessment.