Cervical cancer
Conditions
Interventions
treatment group:1. Induction phase: a treatment cycle every 21 days, pepampriumab injection: 200 mg/time
Anlotinib hydrochloride capsule: 10 mg/time, oral on an empty stomach, continuous use for 2 weeks, stop for 1 week
Paclitaxel injection: 175 mg/m2
Cisplatin injection: 50 mg/m2
Carboplatin injection: AUC 5 mg/mL/min
Sponsors
Fujian Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Persistent, recurrent or metastatic cervical cancer (International Society of Obstetricians and Gynecologists [FIGO] STAGE IVB) confirmed by histopathology with squamous, adenocarcinoma or adenosquamous carcinoma; 2. It is not suitable for radical treatment such as surgery, radiotherapy, concurrent radiotherapy and chemotherapy; 3. No previous systemic treatment for persistent, recurrent or metastatic cervical cancer; 4. All subjects are required to provide archived or freshly obtained tumor tissue samples (formalin fixed paraffin-embedded tissue wax blocks or at least 5 unstained tumor tissue sections) within the last 2 years. Newly obtained tumor tissue samples are preferred) and pD-L1 positive (CPS >= 1) or pD-L1 positive report traceable to 2 years (CPS >= 1); 5. At least one measurable lesion confirmed according to RECIST 1.1; 6. Aged 18-75 years; 7. ECOG score: 0-1; 8. The expected survival time is more than 3 months; 9. Normal function of major organs, that is, meeting the following criteria: (1) Routine blood test (no blood transfusion and no growth factor support within 14 days before screening): hemoglobin (HGB) >= 90 g/L; Neutrophil count (NEUT) >= 1.5x10^9/L; platelet count (PLT) >= 100x10^9/L; (2) Biochemical examination: ALT and AST = 60 mL/min; (3) Coagulation function: activated partial thrombin time (APTT), international standardized ratio (INR), prothrombin time (PT) = 50%; 10. Female subjects of reproductive age should agree to use contraceptive methods (such as iUDS, birth control pills or condoms) during the study period and for 6 months after the end of the study; Serum pregnancy test negative within 7 days prior to study enrollment and must be non-lactating subjects; 11. Patients voluntarily joined the study and signed informed consent with good compliance.
Exclusion criteria
Exclusion criteria: 1. Associated with the following diseases or medical history: (1) The presence or current co-occurrence of other malignant tumors within the past 5 years. The following two conditions can be included: other malignant tumors treated by single surgery, R0 resection and no recurrence and metastasis; Cured non-melanoma skin cancer, nasopharyngeal carcinoma, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor infiltrating basal membrane)]; (2) Pathological findings of mucinous adenocarcinoma, clear cell adenocarcinoma, neuroendocrine tumor and other special pathological types; (3) Unrelieved toxicity higher than GRADE 1 of CTC-AE due to any prior treatment, excluding hair loss and peripheral sensory nerve disorders; (4) Major surgical treatment or significant traumatic injury within 28 days prior to the start of study treatment (excluding needle aspiration, endoscopic biopsy for diagnostic purposes, etc.); (5) Wounds or fractures that have not been cured for a long time; (6) Occurrence of arteriovenous/venous thrombosis events within 6 months, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc.; (7) Those who have a history of psychotropic drug abuse and cannot quit or have mental disorders; (8) Subject with any severe and/or uncontrolled disease, including: 1) Patients with poor blood pressure control after standard treatment (systolic blood pressure >= 150 mmHg or diastolic blood pressure >= 100 mmHg); 2) Patients who have experienced myocardial ischemia or myocardial infarction within six months; NYHA grade >= 2 congestive heart failure; Grade >= 2 atrioventricular block; Arrhythmias that cannot be stably controlled with drugs (including QTc >= 470 ms) and arrhythmias that may have a potential impact on trial treatment; 3) Active infection (>= CTC-AE grade 2 infection); 4) Decompensated cirrhosis, active hepatitis; active hepatitis (hepatitis b reference: HBsAg positive, and HBV DNA > 2,500 copies/mL or gt; 500 iu/mL; Hepatitis C reference: HCV antibody positive, and HCV virus titer test value exceeds the upper limit of normal value); Note: Subjects with positive surface antigen of hepatitis B or positive core antibody and hepatitis C patients eligible for inclusion are advised to continue antiviral therapy to prevent virus activation; 5) Known active syphilis, active tuberculosis; 6) Renal failure requiring hemodialysis or peritoneal dialysis: eGFR 10 mmol/L; 9) Patients with urine protein >= ++ as indicated by routine urine examination, and 24-hour urine protein quantity > 1.0 g; 10) Persons suffering from epilepsy and requiring medical treatment; 11) Previous or existing interstitial pneumonia, non-infectious pneumonia requiring corticosteroid therapy, or current pneumonia of grade 2 or more. 2. Tumor-related symptoms and treatment: (1) Have received surgery, radiotherapy or other anticancer therapy within 4 weeks prior to the start of study treatment (the washout period is calculated from the end of the last treatment); Those who had previously received local radiation therapy were eligible if they met the following criteria: the e
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free Survival;Disease Control Rate;Incidence of adverse events;The quality of life; | — |
Countries
China
Contacts
Public ContactQin Xu
Fujian Cancer Hospital
Outcome results
None listed