NCT07472153RecruitingPhase 2
To Validate, Develop and Implement The Scope of Medical Care for Metastatic, Persistent and Recurrent Cervical Cancer Using The Method of Chemoimmunotargeted Therapy
N.N. Alexandrov National Cancer Centre1 site in 1 country120 target enrollmentStarted: July 1, 2025Last updated:
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Overall survival
Study Overview
Brief Summary
This is a randomized trial evaluating the results of using of PD-1 and PD-L1 immune checkpoint inhibitors combined with chemotherapy, with or without bevacizumab, in patients with metastatic, persistent, and recurrent cervical cancer.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥18-≤75 years.
- •Histologically confirmed diagnosis.
- •One of the forms of the cervical cancer:
- •Metastatic cervical cancer (stage IVB according to FIGO (International Federation of Gynaecology and Obstetrics) 2018);
- •Persistent cervical cancer (primary incurability after radical treatment for stages IIB-IVA cervical cancer according to FIGO 2018);
- •Reccurent cervical cancer (first recurrence after completed radical treatment for IA-IVB cervical cancer according to FIGO 2018).
- •Availability of material for determining PD-L-1 expression for immunotherapy candidates.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •No contraindications to chemotherapy, immunotherapy, or bevacizumab.
- •Signed informed consent to participate in the study.
Exclusion Criteria
- •Presence of another active malignant invasive neoplasm.
- •Pregnancy or lactation period.
Arms & Interventions
PD-1
Experimental
Intervention: PD-1 antibody (Drug)
PD-L1
Experimental
Intervention: PD-L1 antibody (Drug)
Standard
Active Comparator
Intervention: Chemotherapy and bevacizumab (CT-BEV) (Drug)
Outcomes
Primary Outcomes
Overall survival
Time Frame: From enrollment through study completion, an average of 2 year
Time from randomization to the death of any cause
Median overall survival
Time Frame: From date of treatment initiation until the date of death from any cause, assessed up to 36 months
The timepoint at which 50% of patients are still alive following treatment initiation
Secondary Outcomes
- Objective response rate(From randomization until progression or study completion, average of 60 months)
- Duration of response(From date of first documented response until progression or death, assessed up to 60 months)
- Disease-free survival(From enrollment through study completion, an average of 2 year)
- Median Disease-free survival(From date of treatment initiation until the date of death from any cause, assessed up to 36 months)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Recruiting
Phase 1/2
Combining anti-PD-L1 immune checkpoint inhibitor durvalumab with TLR-3 agonist rintatolimod in patients with metastatic pancreatic ductal adenocarcinoma for therapy efficacy. DURIPANC Study2024-514597-42-00Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)43
Recruiting
Phase 2
PD-1 Inhibitor Plus Chemotherapy Followed by Immediate Versus Selective Re-irradiation for Locally Advanced Recurrent NPCNCT07332247Sun Yat-sen University94
Not yet recruiting
Phase 2
A Prospective, Single-Arm, Phase II Study: PD-L1 Monoclonal Antibody + Chemoradiotherapy as Bridge Therapy to Liver Transplantation for Locally Advanced Perihilar Cholangiocarcinoma (ACHIEVE-LT)NCT07471165The First Affiliated Hospital with Nanjing Medical University25
Recruiting
Not Applicable
The Efficacy of PD-1 Monoclonal Antibody Combined With Chemotherapy in Metastatic Gastric Cancer Based on Gut MicrobiotaGastric CancerNCT07400354Fudan University300
Recruiting
Phase 2
PD-1 Inhibitor Combined With Rituximab, Methotrexate, and Orelabrutinib (PD-1i+RMO) for Newly Diagnosed PCNSL and SCNSL.NCT07410520The First Affiliated Hospital with Nanjing Medical University50