A Phase 2 interventional study of Zimberelimab and Platinum in Cervical Cancer, sponsored by Obstetrics & Gynecology Hospital of Fudan University. Not yet recruiting. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-11-30.
Sponsored by Obstetrics & Gynecology Hospital of Fudan University · Phase 2, Interventional, and Treatment
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.
For cervical cancer, although clinical research on PD-1 monoclonal antibodies was launched relatively late, the research results so far show that PD-1 monoclonal antibodies combined with chemotherapy have a high clinical effectiveness and a relatively high efficacy in the treatment of advanced/recurrent cervical cancer. Good security. However, there is currently a lack of clinical evidence for the use of PD-1 monoclonal antibodies combined with chemoradiotherapy in the treatment of high-risk patients after cervical cancer surgery. Therefore, this study intends to explore the clinical efficacy of postoperative adjuvant radiochemotherapy followed by PD-1 monoclonal antibody in the treatment of high-risk patients with locally advanced (IB3, IIA2) cervical cancer after surgery, and provide a new solution for clinical treatment.
1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.
This study's planned enrollment of 24 is below the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Obstetrics & Gynecology Hospital of Fudan University is the lead sponsor of 23 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1. Radiotherapy: Intensity modulated conformal radiation therapy (IMRT) is used for external irradiation, and the pelvic target volume dose (PTV) is: 45-50 Gy/1.8Gy/25-28f; the stump margin is positive, and after the external irradiation is completed, Additional CT-guided three-dimensional conformal brachytherapy, HR-CTV: 24--30Gy/4-5f. 2. Concurrent chemotherapy: performed during external radiotherapy. Starting from the first week of radiochemotherapy, cisplatin 40 mg/m2 was given. Chemotherapy is given every 7 days, up to 5-6 times; 3. Zimberelimab injection: 240 mg/time, intravenous infusion, administered every 21 days, starting within four weeks after completing concurrent chemoradiotherapy, and maintained for 8 cycles
Drug: Zimberelimab · Drug: Platinum · Radiation: radiotherapy
240mg, q3w,8 cycles
cisplatin 40mg/m2 for 5-6 cycles
45-50Gy/1.8Gy/25-28f
changes in tumor-related biomarkers
changes of tumor- related biomarkers (T cell receptor library profile and peripheral blood ctDNA content analysis)
Time frame: 3 years
OS
Overall Survival
Time frame: 5 years
DFS
Disease Free Survival
Time frame: 2 years
AE
Adverse event
Time frame: 3 years
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Obstetrics & Gynecology Hospital of Fudan University