NCT06128460Not yet recruitingPhase 2
Adjuvant Chemoradiotherapy Followed by Zimberelimab for Locally Advanced Cervical Cancer.
Adjuvant Chemoradiotherapy Followed by Zimberelimab for Locally Advanced Cervical Cancer (IB3, IIA2) Patients
Source: ClinicalTrials.gov · Last updated 30 Nov 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Locally advanced cervical cancer (stage IB3, IIA2) patients with postoperative risk factors need better treatment. We initiated a clinical study to explore the effectiveness of adjuvant chemoradiotherapy followed by Zimberelimab for these patients.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 6 Nov 2023
- Start date
- 1 Dec 2023
- Primary completion date
- 1 Dec 2025
- Lead sponsor
- Obstetrics & Gynecology Hospital of Fudan University
- Diseases
- Cervical cancer
- NCT number
- NCT06128460
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 24
- From 1 Dec 2023 to the primary completion date, 1 Dec 2025
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participate in or have participated in other clinical trials within 4 weeks before enrollment;
- Have received or will receive inactivated vaccine within 30 days prior to the first study treatment;
- Received a combination of systemic immune stimulants, colony-stimulating factors, interferon, interleukin, and vaccine within 6 weeks or 5 half-lives (if shorter) prior to initial administration;
- Have been diagnosed with an immune deficiency or are receiving chronic systemic steroid therapy (doses greater than 10mg daily equivalent of prednisone) or any other form of immunosuppressive therapy within 7 days prior to the first dose;
- Has received allogeneic tissue/solid organ transplantation;
Other illness
- Severe hypersensitivity to cepalizumab and/or any of its excipients (≥ grade 3);
- Have an active autoimmune disease in the past 2 years that requires systemic treatment (such as the use of disease-modulating drugs, corticosteroids, or immunosuppressive drugs);
- Have a history of (non-infectious) pneumonia requiring steroid treatment or have a current (non-infectious) pneumonia;
- An active infection requiring systematic treatment;
- Known history of HIV infection;
- A known history of hepatitis B (defined as HBsAg reactive) or known active hepatitis C virus (defined as detection of HCV RNA\[qualitative\]) infection;
- Known active tuberculosis (TB; Tuberculosis) medical history;
- Patients with mobility disorders such as pathological fractures caused by tumor bone metastasis;
- Bleeding risk;
Other
- Subjects have histological subtypes other than those permitted by inclusion criteria;
- Suffering from central nervous system metastases such as brain metastases;
- Patients with uncontrolled chest and abdominal fluid;
- Insufficient hematopoietic function of bone marrow;
- Abnormal liver;
- Abnormal kidney;
- Cardiovascular and cerebrovascular abnormalities.
Who the study is looking for
- Histologically confirmed cervical squamous cell carcinoma, cervical adenocarcinoma, or cervical adenosquamous carcinoma;
- According to FIGO2018 staging, patients with locally advanced cervical cancer (IB3, IIA2) who require concurrent radiotherapy and chemotherapy;
- Patients with radical surgery for cervical cancer;
- Female patients: 18-70 years old;
- ECOG physical condition score: 0\~1 point;
- Subjects have not received previous immunotherapy;
- Expected survival ≥6 months;
- Women of reproductive age should agree to use contraceptives (such as Iuds, contraceptives, or condoms) during the study period and for 6 months after the study ends; Have a negative serum or urine pregnancy test within 7 days prior to study enrollment and must be a non-lactating patient;
- For adequate organ function as defined in the protocol, test samples must be collected within 7 days prior to initiation of the study therapy
- Subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up.
Age in the registry: 18 years to 70 years · Sex: Female · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.