cervical cancer
Conditions
Interventions
Cohort 1:Induction phase: enlonstobart+paclitaxel+cisplatin/carboplatin±bevacizumab.
Concurrent phase: radiotherapy+cisplatin/carboplatin+enlonstobart.
Maintenance phase: enlonstobart.
Cohort 2:Induction phase: enlonstobart+paclitaxel+cisplatin/carboplatin±bevacizumab.
Concurrent phase: radiotherapy+cisplatin/carboplatin+enlonstobart.
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Female, age =18 and =70; 2. Histologically confirmed squamous carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix; 3. FIGO 2018 Stages IB3, IIA2, IIB, IIIA-IVA cervical cancer and without any treatment; 4. At least one assessable lesion per RECIST 1.1; 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; 6. According to the investigator's judgment, the expected survival time was =3 months; 7. Has provided tumor tissue sample for PD-L1 expression testing; 8. Adequate organ function as defined below: 1)Blood routine tests (No blood transfusions, hematopoietic stimulating factors, or other medications were used to correct blood cell counts for 14 days): White blood cell count (WBC)=2.5×10^9/L; Absolute neutrophil count (ANC) =1.5×10^9/L; Platelets =90×10^9/L; Hemoglobin (HGB)=90g/L; 2)Serum biochemical indexs: Serum creatinine =1.5 × ULN or >1.5 × ULN with creatinine clearance (CCr) = 60 mL/min; Serum total bilirubin (TBIL) = 1.5 × ULN; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =2.5 × ULN; 3)Coagulation function: Activated partial thromboplastin time (APTT) and International normalized ratio (INR) =1.5×ULN; 4)Thyroid function: Thyroid stimulating hormone (TSH) =ULN, Free triiodothyronine (FT3), Free thyroxine (FT4) levels were normal; 9. Female patients of childbearing age who had a negative pregnancy test, were not lactating, and were of childbearing potential were required to receive effective medical contraception (from the time they signed the informed consent until 6 months after the last study dose). 10. Has good compliance with the planned treatment and follow-up, understood the study procedures of this study, and signed informed consent form.
Exclusion criteria
Exclusion criteria: 1. Has distant metastasis; 2. Any prior antitumor therapy, including but not limited to surgery (other than biopsy), radiotherapy, or systemic therapy (chemotherapy, immunotherapy, targeted therapy); 3. Prior therapy with any immune checkpoint inhibitors, including but not limited to anti-PD-1, anti-PD-L1. 4. Active malignancy within 3 years prior to first dose of the investigational drug, except for cervical cancer studied in this trial and any locally curable tumor that has received radical therapy (e.g., resected basal or squamous cell skin cancer, superficial bladder cancer, cervical cancer in situ, breast cancer in situ, etc). 5. Patients has active autoimmune disease or a history of autoimmune disease within 2 years before enrollment for which systemic therapy was still required. However, patients with well-controlled type I diabetes, well-controlled hypothyroidism with hormone replacement therapy, skin diseases (such as vitiligo, psoriasis, or hair loss) without systemic treatment, or those who are not expected to relapse without external triggers, were allowed for further screening. 6. History of primary immunodeficiency; 7. Has received immunosuppressive therapy (e.g., cyclosporine) within 14 days before enrollment or the need for daily systemic steroid therapy, unless topical glucocorticoids were administered by nasal spray, inhalation or other route; 8. Human immunodeficiency virus antibody (HIV-Ab) positive or patients with active syphilis; Hepatitis B virus surface antigen (HBsAg) positive, and hepatitis B virus detection value (HBV-DNA) > 500IU/ml or 2500 copies/mL; HCV antibody (HCV-Ab) was positive, and HCV RNA quantification exceeded the upper limit of normal value of the detection unit; 9. Active bacterial, fungal, or viral infection (defined as the need for intravenous antibacterial, antifungal, or antiviral treatment) within 14 days before enrollment. Those who had no clinical manifestations of active infection before the first treatment and were given infection prophylaxis could be considered for enrollment. 10. Has active tuberculosis or a history of active tuberculosis; 11. Serious cardiovascular disease within 6 months prior to the first dose, including but not limited to: stable angina with functional class III-IV; unstable angina or myocardial infarction; NYHA grade III-IV congestive heart failure; severe arrhythmias requiring drug therapy (congestive heart failure allowed if ventricular rate can be controlled; severe arrhythmias requiring drug therapy (asymptomatic atrial fibrillation is allowed if the ventricular rate can be controlled); Severe arterial/venous thrombotic events (such as cerebral hemorrhage, cerebral infarction, deep vein thrombosis, pulmonary embolism, arterial thromboembolism, etc.). 12. Has interstitial lung disease or a history of interstitial lung disease. Or non-infectious pneumonitis requiring glucocorticoid therapy; 13. Presence of clinically significant hydronephros which cannot be relieved by ventriculostomy or ureteral stent placement assessed by investigator; 14. Current grade =3 proteinuria (24-hour urine protein =3.5g or 4+ proteinuria); 15. Has receipted of live or attenuated vaccine within 28 days before enrollment or planned for the duration of the study; 16. History of organ transplant or allogenic haemopoietic stem cell transplantation. 17. History of severe allergic reactions and uncontrolled allergic asthma to all components of the monoclonal antibody formulation; 18. Has
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2 year-PFS rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;During of response;Progression free survival;Overall survival;Safety; | — |
Countries
China
Contacts
Public ContactGuiling Li
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed