Last updated: October 11, 2022
Sponsor: Shanghai Zhongshan Hospital
Overall Status: Active - Recruiting
Phase
2
Condition
Cervical Cancer
Uterine Disorders
Treatment
N/AClinical Study ID
NCT05437692
B2022-213R
Ages 18-75 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- FIGO 2018 stage IIB to IVA cervical cancer;
- Cervical squamous cell carcinoma, cervical adenocarcinoma or cervical adenosquamouscarcinoma confirmed by histology;
- Have not received any radiotherapy for cervical cancer in the past, and have notreceived immunotherapy;
- Have measurable lesions (according to RECIST v1.1 standard);
- ECOG score: 0 ~ 1;
- 18~75 years old (calculated on the day of signing the informed consent);
- The estimated survival period exceeds 6 months;
- Before enrollment, try to provide enough tumor tissue samples (archived or freshbiopsy samples) to evaluate and confirm the expression of PD-L1 and to detect otherbiomarkers; Considering the accessibility of clinical specimens, there is no mandatoryrequirement for specimens;
- Women of childbearing age should agree to use contraceptives (such as intrauterinedevices, contraceptives or condoms) during the study period and within ● months afterthe end of the study; Within 7 days before the study was enrolled, the serum or urinepregnancy test was negative, and must be non lactating patients;
- For the full organ function defined in the protocol, the test samples must becollected within 7 days before the start of the study treatment;
- The patients volunteered to join the study and signed the informed consent form.
Exclusion
Exclusion Criteria:
- The subjects have other histological subtypes except those permitted by inclusioncriteria 2;
- Bilateral hydronephrosis, unless at least one side has been implanted with a stent orsolved by a positioned nephrostomy;
- Those who are allergic to gadolinium, a common non-ionic CT contrast agent and amagnetic resonance contrast agent
- Have anatomical structure or tumor geometry or any other reasons or contraindicationsthat cannot be treated with intracavitary brachytherapy or intracavitary andimplantable brachytherapy;
- Severe hypersensitivity (≥ grade 3) to cepalimumab and / or any of its excipients;
- Participated in or had participated in clinical trials within 4 weeks beforerandomization;
- Have been vaccinated or will be vaccinated with live vaccine within 30 days before thefirst study treatment;
- Have received systemic immune stimulant, colony stimulating factor, interferon,interleukin and vaccine combination treatment within 6 weeks or 5 half lives (whichever is shorter) before the first administration;
- Within 7 days before the first administration, the patient has been diagnosed withimmune deficiency or is receiving chronic systemic steroid therapy (the dose exceeds 10mg prednisone equivalent per day) or any other form of immunosuppressive therapy;
- Active autoimmune diseases requiring systemic treatment during the past two years (such as the use of disease regulating drugs, corticosteroids or immunosuppressivedrugs);
- Have a history of (non infectious) pneumonia requiring steroid treatment or currentlyhave (non infectious) pneumonia;
- Active infection requiring systematic treatment;
- Known HIV infection history;
- Known hepatitis B (defined as HBsAg reactivity) or known active hepatitis C virus (defined as detection of HCV RNA [qualitative]) infection history;
- Known history of active tuberculosis (TB; Mycobacterium tuberculosis);
- Received allogeneic tissue / solid organ transplantation;
- Central nervous system metastasis such as tumor brain metastasis;
- Patients with uncontrolled hydrothorax and ascites;
- Patients with movement disorders such as pathological fractures caused by tumor bonemetastasis;
- Insufficient hematopoietic function of bone marrow (without blood transfusion within 14 days):
- Abnormal liver:
- Abnormal kidney:
- Risk of bleeding:
- Cardiovascular and cerebrovascular abnormalities:
Study Design
Total Participants: 19
Study Start date:
July 15, 2022
Estimated Completion Date:
July 01, 2025
Study Description
Connect with a study center
Shanghai Zhongshan hospital
Shanghai, Shanghai 200032
ChinaActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.