cervical carcinoma
Conditions
Interventions
Chemotherapy group:TC scheme
Targeting therapy group:TC scheme+Apatininb
Immunotherapy group:TC scheme+SHR-1210
Sponsors
Shandong Institute of Cancer Prevention and Control
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years; 2. Cervical squamous cell carcinoma, adenosquamous cell carcinoma or adenocarcinoma confirmed by pathology at the time of initial treatment. It does not include the following rare pathological types of tumors: microbial adenocarcinoma, villous tubular adenocarcinoma, clear cell carcinoma or sarcoma. 3. Patients with advanced stage (IVB) and recurrent cervical cancer who are not suitable for surgery and/or radiotherapy; 4. Diagnosis of advanced and recurrent cervical cancer: Advanced and recurrent lesions (including local recurrence or distant metastasis) can be confirmed by histology or cytology as recurrence. Histology or cytologists are unavailable, and clinical diagnosis can be provided by combining medical history, laboratory and imaging examinations (such as CT, MRI, PET/CT). 5. There is at least one measurable lesion (according to RECIST 1.1 standard, the length of CT scan of tumor lesion is greater than or equal to 10 mm, and the short diameter of CT scan of lymph node lesion is greater than or equal to 10 mm). 6. ECOG score: 0-1; 7. The estimated survival period is longer than or equal to 3 months. 8. The damages caused by other treatments were recovered, with the interval of receiving nitroso or mitomycin (> 6 weeks), other cytotoxic drugs, radiotherapy or surgery (> 4 weeks) and the wound healed completely. 9. Subjects in the targeted therapy group should not have received any inhibitors of vascular endothelial growth factor R, such as sorafenib or sunitinib. 10. Subjects in the immunotherapy group should not have received other PD-1 antibody therapy or other immunotherapy for PD-1/PD-L 1 in the past. 11. The function of the main organs is normal, which meets the following criteria: (1) Blood routine examination standards should be met (no blood transfusion and blood products within 14 days): ANC (>1.5*10^9/L); B. PLT (> 80 *10^9/L); (2) Biochemical tests should meet the following criteria: TBIL 45 ml/min (Cockcroft-Gault formula); 12. Patients with potential fertility need to use a medically acceptable contraceptive measure (such as intrauterine device, contraceptive pill or condom) during the study period and within one month after the end of the study period, and HCG tests in serum or urine must be negative within 72 hours before the study group and must be non-lactating. 13. Subjects joined the study voluntarily and signed the informed consent. They had good compliance and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Severe allergic reactions to apatinib and/or its excipients and other monoclonal antibodies have been confirmed. 2. Patients had received systemic chemotherapy for cervical cancer (except concurrent radiotherapy and chemotherapy). 3. Subjects had any history of active autoimmune diseases or autoimmune diseases (e.g., autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism); Subjects had vitiligo or had complete remission of childhood asthma, and no need for any treatment in adults). Interventions can be included; asthma patients who need bronchodilators for medical intervention can not be included; 4. Subjects were using immunosuppressive agents or systemic or absorbable local hormones for immunosuppressive purposes (dosage > 10mg/prednisone or other therapeutic hormones) and were still using them within 2 weeks before admission. 5. Patients with hypertension who cannot be reduced to normal range by antihypertensive drugs (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg) 6. According to NYHA criteria, patients with grade III-IV cardiac insufficiency or with left ventricular ejection fraction (LVEF) less than 50% indicated by color Doppler echocardiography; 7. In patients with positive urinary protein (++), 24-hour urinary protein was confirmed to be more than 1.0 G. 8. There are many factors affecting oral medicines (such as inability to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction). 9. Patients with a definite tendency of gastrointestinal bleeding include the following: patients with locally active ulcer lesions and fecal occult blood {(++) not admitted to the group); patients with a history of melena and hematemesis within 2 months; 10. Coagulation dysfunction (INR > 1.5 APTT > 1.5 ULN), with bleeding tendency; 11. Long-term unhealed wounds or fractures; major surgical operations or severe traumatic injuries, fractures or ulcers within 4 weeks; 12. Subjects with congenital or acquired immunodeficiency (e.g. HIV-infected persons) or active hepatitis (hepatitis B reference: HBV DNA detection exceeded the upper limit of normal value; hepatitis C reference: HCV virus titer or RNA detection exceeded the upper limit of normal value); 13. Patients with central nervous system metastasis; 14. Pregnant or lactating women; 15. Those who have a history of psychotropic drug abuse and are unable to quit or have mental disorders; 16. According to the judgement of the researcher, patients with concomitant diseases that seriously endanger the safety of patients or affect the completion of patients'studies; 17. Researchers do not think it is suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;DOR;DCR;ORR; | — |
Countries
China
Contacts
Public ContactNaifu Liu
Shandong Institute of Cancer Prevention and Control
Outcome results
None listed