Last updated: July 12, 2022
Sponsor: Zhejiang Cancer Hospital
Overall Status: Active - Recruiting
Phase
2
Condition
Cervical Cancer
Vaginal Cancer
Pelvic Cancer
Treatment
N/AClinical Study ID
NCT05247619
BGB-A317-2007
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Voluntary participation and signature of informed consent;
- Age ≥18;
- Eastern United States Cancer Collaboration Group (ECOG) score 0-1;
- Patients with metastatic (IVB), persistent or first recurrent cervical cancer isunsuitable for surgical treatment;
- Histopathology was defined as: cervical squamous cell carcinoma, adenocarcinoma,adenosquamous carcinoma, patients included in adenocarcinoma histology will be limitedto 20% of the entire study population;
- Patients must have lesions that can be measured according to RECIST v1.1 criteria;
- The main organs function well and are defined as:
- Patients received no blood, platelet transfusion or growth factor supporttreatment within 14 days ≤ the beginning of treatment and was required to:
- x 109/L ANC ≥1.5
- Platelet ≥100 x 109/L
- g/L ≥90
- AST and ALT≤2.5 times ULN (5 times if liver metastasis occurs)
- Serum total bilirubin ≤ ULN 1.5 times
- Serum creatinine <1.5x upper limit (ULN)
- Urine routine examination, urine protein <2+
- The internationally standardized ratio (INR)≤1.5 or prothrombin time ULN 1.5times
- The activated partial thromboplastin time (aPTT)≤1.5 times ULN time
- Serum albumin ≥30 g/L
- Life expectancy ≥3 months;
- Pregnant women must agree to effective contraception ≥120 days during the study periodand after the last drug administration, and the results of serum pregnancy tests werenegative 7 days ≤ before the first drug administration;
Exclusion
Exclusion Criteria:
- Patients whose bilateral hydronephrosis can not be alleviated by ureteral stent orpercutaneous drainage; non-communicable cystitis CTCAE(5.0 Edition)≥ grade 2;
- Exclusion criteria of bevacizumab, i.e. clinical significance of cardiovascular andcerebrovascular diseases, abdominal fistula or gastrointestinal perforation history,acute intestinal obstruction or subimpedance, active bleeding;
- hypertension (systolic blood pressure greater than 140 mmHg and/or diastolic bloodpressure greater than 90 mmHg), hypertension crisis or history of hypertensiveencephalopathy, which remains uncontrolled under medication;
- Previous medical history showing newly discovered thrombotic disease within 6 monthsof screening or during screening; patients with severe wound nonunion, ulcers orfractures;
- Patients with other malignancies and brain metastases;
- Patients with central nervous system diseases, including uncontrolled seizure standarddrug therapy, or historical cerebrovascular accidents (CVA, stroke), transientischemic attacks (TIA) or subarachnoid hemorrhage within six months.
- Previous treatment with antiprogrammed cell death protein-1(anti PD-1), antiprogrammeddeath ligand-1(anti PD-L1) or anti PD-L2 drugs, or have received another drugtreatment (e.g., cytotoxic T lymphocyte-associated antigen-4[ CTLA-4]、OX-40,] antigenpatients CD137[ tumor necrosis factor receptor superfamily member 9(TNFRSF9)]; Apatient who has previously received any VEGF drugs, including bevacizumab.
- Patients who received live vaccinations or had undergone major surgery within 30 daysprior to the first administration of the study; patients who were expected to undergoinvasive surgery during treatment;
- Active autoimmune diseases requiring systemic treatment in the past two years;
- ≤14 days before the first administration of the study drug, any condition requiringsystemic treatment with corticosteroids (prednisone or equivalent >10 mg/ days) orother immunosuppressive drugs;
- History of known human immunodeficiency virus (HIV) infection;
- Untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers (HBV DNA >500 IU/mL) or active HCV carriers with detectable levels; Note: Non-active hepatitisB surface antigen (HBsAg) carriers, treated and stable hepatitis B patients (HBV DNA <500 IU/mL) can be enrolled;
- History of interstitial lung disease, non-infectious pneumonia or uncontrolleddisease, including pulmonary fibrosis, acute lung disease, etc;
- Severe chronic or active infections (including tuberculosis infections) requiringsystemic antimicrobial, antifungal or antiviral therapy within 14 days prior to thefirst administration of the study drug Note: Patients with viral hepatitis are allowedantiviral therapy;
- with severe cardiovascular diseases such as myocardial infarction, acute coronarysyndrome, or coronary angioplasty/stenting/bypass transplantation in the past 6months, or new york heart disease association (NYHA) class ii-class IV congestiveheart failure (CHF), or history of class NYHA III or IV CHF;
- who are known to be allergic to components of a study drug or its analog;
- Participate in another clinical study at the same time, unless it is an observational (non-intervention) clinical study or at a follow-up period of an intervention study;
- Pregnant or lactating women;
- Previous heterogenous stem cell transplantation or organ transplantation;
- Other conditions judged by the researchers did not meet the requirements of the group.
Study Design
Total Participants: 49
Study Start date:
June 30, 2022
Estimated Completion Date:
January 31, 2025
Study Description
Connect with a study center
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
ChinaActive - Recruiting

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