Last updated: November 28, 2023
Sponsor: Fujian Cancer Hospital
Overall Status: Active - Not Recruiting
Phase
2
Condition
Cervical Cancer
Vaginal Cancer
Uterine Disorders
Treatment
Adebrelimab
Clinical Study ID
NCT06149767
23-OBU-FJ-CA-001
Ages 18-75 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- The subjects understand and voluntarily participate in the study, sign the informedconsent form (ICF), have good compliance, and cooperate with follow-up;
- Female, 18 years of age ≤75 years of age on the date of signing the informed consent;
- Cervical squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma confirmedby histopathology or cytology;
- FIGO 2018 consists of patients with stage IIB - IVA. Note: Lymph nodes with confirmedmetastasis are required for diagnosis of stage ⅢC1. Lymph node metastasis diagnosiscan be confirmed by biopsy or imaging diagnosis, and the following criteria must bemet for imaging diagnosis of lymph node metastasis: MRI or CT showing positive lymphnodes (minimum transverse diameter ≥15 mm)
- Have not previously received any radical surgery, radiotherapy or systemic treatment (including investigational drugs) for cervical cancer, and have not receivedimmunotherapy;
- An American Eastern Oncology Collaboration (ECOG) score of 0 or 1 within 7 days priorto the first study intervention;
- There is at least one measurable lesion that meets the requirements of RECIST v1.1standard (tumor lesion with CT scan diameter ≥10mm, lymph node lesion with CT scandiameter ≥15mm, and scan layer thickness 5mm);
- Expected survival ≥6 months;
- The major organs function normally and meet the following criteria:
(1) Blood routine examination must meet:
- Hemoglobin (Hb)≥90g/L
- White blood cell count (WBC)≥3×109/L
- Neutrophil count absolute value (ANC)≥1.5×109/L
- Platelet count (PLT)≥100×109/L; (2) Biochemical examination shall meet the followingstandards: a. Serum total bilirubin (TBIL) ≤1.5 × ULN (total bilirubin (BIL)≤3.0 mg/dL in patientsdiagnosed with Gilbert syndrome) b. Alanine aminotransferase (ALT) and aspartateaminotransferase (AST)≤3ULN c. Albumin (ALB) ≥3 g/dL d. Serum Cr≤1.5ULN, endogenouscreatinine clearance ≥60ml/min (Cockcroft-Gault formula); (3) The coagulation function testshall meet the following criteria:
- International Standardized Ratio (INR) ≤1.5
- Activated partial thromboplastin time (APTT) ≤1.5 ×ULN; 10. In potentially fertilewomen, serum or urine HCG negative for 72 hours prior to enlistment (postmenopausalwomen must be considered infertile for at least 12 months and a pregnancy test is notrequired for women who have been confirmed to have undergone tubal ligation), Femalesubjects of reproductive age and male subjects with a partner of a woman ofreproductive age must consent to contraception for 24 weeks from the date of signingthe informed consent to the last administration of the study drug.
Exclusion
Exclusion Criteria:
- Subjects have histological subtypes other than those permitted by inclusion criteria 3;
- Evidence of metastatic lesions according to RECIST 1.1 (including proximal L1 level orabove or inguinal regional lymph nodes);
- Have had a hysterectomy (defined as removal of the entire uterus) or had ahysterectomy as part of their initial treatment for cervical cancer;
- Bilateral hydronephrosis, which the investigators judged could not be relieved bynephrostomy or ureteral stenting;
- Patients with uncontrolled vaginal bleeding;
- Previous allergy to any investigational drug ingredient;
- Participate in clinical studies of other investigational drugs within 3 months priorto screening;
- Other malignancies developed within 5 years prior to admission, excluding adequatelytreatable basal cell or squamous cell skin cancer, local prostate cancer after radicalsurgery, and ductal carcinoma in situ after radical surgery;
- Have any active autoimmune disease or history of autoimmune disease (such asinterstitial pneumonia, uveitis, enteritis, hepatitis, pituitaritis, vasculitis,myocarditis, nephritis, hyperthyroidism, hypothyroidism, including but not limited tothese diseases or syndromes); Except for patients with vitiligo or childhoodasthma/allergies that have healed and do not require any intervention as adults;Autoimmune mediated hypothyroidism treated with a steady dose of thyroid replacementhormone; Type 1 diabetes using steady doses of insulin;
- A history of immunodeficiency, including HIV testing positive, or other acquired orcongenital immunodeficiency diseases, or a history of organ transplantation andallogeneic bone marrow transplantation;
- Accompanied by serious heart, lung, liver, kidney disease; Having neurological ormental illness; Jaundice or digestive tract obstruction with severe infection;
- Patients with hypertension who are not well controlled by antihypertensive drugs (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg); Or grade IIor above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥450ms for men and ≥470ms for women); According to NYHAcriteria, patients with grade Ⅲ to Ⅳ cardiac insufficiency or left ventricularejection fraction (LVEF) < 50% indicated by cardiac color ultrasound;
- Urine routine suggests urinary protein ≥(++), or 24h urinary protein ≥1g or severehepatic and renal insufficiency;
- Patients with Crohn's disease and ulcerative colitis;
- Subjects who have received systemic treatment with corticosteroids (>10 mg/ day ofprednisone or other equivalent hormones) or other immunosuppressants within 2 weeksprior to initial dosing. In the absence of active autoimmune disease, inhaled ortopical corticosteroids are permitted, as well as adrenal hormone replacement therapyat doses ≤10 mg/ day of prednisone efficacy;
- Pregnant or lactating women, fertile subjects unwilling or unable to take effectivecontraceptive measures;
- Those deemed unsuitable for inclusion by the researchers.
Study Design
Total Participants: 26
Treatment Group(s): 1
Primary Treatment: Adebrelimab
Phase: 2
Study Start date:
January 01, 2024
Estimated Completion Date:
March 31, 2028