Squamous cell carcinoma, adEnocarcinoma and adenosquamous cell carcinoma
Conditions
Interventions
Test group:Treatment phase 6 cycles
Anlotinib:
10mg, taken orally for 2 weeks and stopped for 1 week. D1-D14 medication per cycle, 21 days as a treatment cycle
immune checkpoint inhibitors (ICIs):
PD-1/L1 monoclonal antibodies, CTLA-4 monoclonal antibodies, and bispecific antibodies are acceptable
Platinum-based chemotherapy: Chemotherapy agent selection at the discretion of the investigator
Maintenance Phase:
Anlotinib:
10mg, taken orally for 2 weeks and stopped for 1 week. D1-D14 medication p
ICI:
Every 21 days is a treatment cycle, and subjects continue to take the drug until one of the following occurs: loss of clinical benefit, death, initiation of new anti-tumor therapy, toxicity intol
Sponsors
Henan Provincial Cancer Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily participate in this study and sign an informed consent form; 2. Females aged 18 years and 70 years old, for female patients aged >70 years the investigator can decide whether to enroll in the group according to the patient's physical strength score, etc.; 3. ECOG score of 0 or 1 with predicted survival of not less than 3 months; 4. For persistent, recurrent or metastatic squamous cell carcinoma, adenocarcinoma and adenosquamous cell carcinoma; 5. The patient is not suitable for curative therapy (surgery or radiotherapy); 6. Patients with recurrent or metastatic disease who have not received systemic chemotherapy and are allowed to receive radiotherapy or concurrent chemoradiotherapy enrollment of patients, which needs to be completed at least 2 weeks prior to enrollment and adverse reactions reduced to Grade 1 or less; 7. There may be a 1-week washout period for palliative radiotherapy with non-central neuropathology; 8. Patient has measurable lesions as defined by RECIST1.1 criteria; 9. The function of major organs is good, and the laboratory examination indicators are satisfied: (1) Routine blood examination (no blood transfusion, no use of hematopoietic stimulating factors within 7 days before screening): 1) Hemoglobin (HB) > = 90g/L; 2) Absolute neutrophil count (ANC) >=1.5×10^9/L; 3) Platelets (PLT) > = 80×10^9/L; (2) Blood biochemical examination (no transfusion of blood or albumin within 7 days prior to screening): 1) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =60 ml/min; (3) Coagulation function test: 1) Activated partial thromboplastin time (APTT), International normalized ratio (INR), thrombin original Time (PT) = 50%; 10. Toxicity and side effects of any prior therapy have recovered to <=CTCAE1 grade or baseline level; 11. The patient has the ability to take medication orally; 12. Female subjects of childbearing potential must agree to be taken during the study and within 6 months after the last administration of study drug use of highly effective methods of contraception; Negative serum or urine pregnancy test within 7 days prior to study enrollment and must be non-lactating subjects;
Exclusion criteria
Exclusion criteria: Patients with any of the following cannot be enrolled in this study: 1. Participate in other clinical trials, or complete other clinical trials within 4 weeks; 2. Abnormal coagulation function (INR>2.0, PT>16s), bleeding tendency or receiving thrombolysis or anticoagulation therapy; 3. Prior use of medications without recovery from adverse events (other than alopecia); 4. The patient has any active autoimmune disease or has a history of autoimmune disease; 5. Have uncontrolled cardiac clinical symptoms or diseases; 6. Patients with congenital or acquired immunodeficiency; 7. Comorbid Illness/History: (1) Clinically significant hemoptysis (more than 50ml of hemoptysis per day) within 3 months prior to enrollment; or significant clinically significant bleeding symptoms or clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood and above at baseline, or vasculitis, etc.; (2) Arteriovenous thrombosis events occurring within 6 months prior to enrollment, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis (except for those with venous thrombosis caused by intravenous catheterization in the early stage of chemotherapy and judged to have been cured by the investigator) and pulmonary embolism; (3) hypertension that cannot be well controlled by antihypertensive drugs (systolic blood pressure > 140 mmHg or diastolic blood pressure >90 mmHg); Within 6 months prior to enrollment, the following conditions: myocardial infarction, severe/unstable angina, NYHA grade 2 or above cardiac insufficiency, clinically significant supraventricular or ventricular arrhythmias, and symptomatic congestive heart failure; (4) Interstitial lung disease, non-infectious pneumonia or uncontrollable systemic diseases (such as diabetes, pulmonary fibrosis and acute pneumonia, etc.); (5) Renal insufficiency: urine routine showed urine protein >= ++, or confirmed 24-hour urine protein volume = 1.0g; (6) History of live attenuated vaccination within 28 days prior to the first study administration or expected live attenuated vaccination during the study period; (7) Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); Active hepatitis (hepatitis B, defined as HBV-DNA >= 500 IU/ml; Hepatitis C, defined as HCV-RNA above the lower limit of detection of the analytical method) or co-infection with hepatitis B and C; (8) Severe infection within 4 weeks before the first dose, including but not limited to bacteremia requiring hospitalization, severe pneumonia, etc.; Active infection requiring treatment with systemic antibiotics within 2 weeks prior to the first dose> or unexplained fever >38.5°C during the screening period/prior to the first dose (as judged by the investigator, fever due to tumor causes may be enrolled); Evidence of active tuberculosis infection within 1 year prior to dosing; (9) Have a diagnosis of any other malignancy within 3 years prior to study entry; (10) Major surgery within 6 weeks prior to enrollment; 8. Subjects who have previously received or are preparing to undergo allogeneic bone marrow transplantation or solid organ transplantation; 9. Peripheral neuropathy >=grade 2; Patients with active brain metastases, carcinomatous meningitis, spinal cord compression, or disease of the brain or leptomeninges detected by imaging CT or MRI at screening (patients with brain metastases who have completed treatment and have stable symptom
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease control rate;uration of response;Safety;Progression-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactCheng Shuxia
Henan Provincial Cancer Hospital
Outcome results
None listed