Actively Recruiting
Concurrent Chemoradiotherapy Followed by PD-1 Inhibitor in Advanced Cervical Cancer
Led by RenJi Hospital · Updated on 2024-04-30
20
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To explore the safety and efficacy of Albumin-Bound Paclitaxel/Platinum based concurrent chemoradiotherapy Followed by PD-1 inhibitor (Sintilimab) in locally advanced cervical cancer
CONDITIONS
Official Title
Concurrent Chemoradiotherapy Followed by PD-1 Inhibitor in Advanced Cervical Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Untreated patients with pathologically confirmed locally advanced cervical cancer
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Adequate blood cell counts: hemoglobin > 8.0 g/dl, neutrophils > 2000 cells/µl, leukocytes > 4 x 10^9/L, platelets > 100 x 10^9/L
- Adequate kidney and liver function: serum urea nitrogen ≤ 1.5 times upper normal limit, serum creatinine ≤ 1.5 times upper normal limit, serum ALT/AST ≤ 2.5 times upper normal limit, serum total bilirubin ≤ 1.5 times upper normal limit
- Life expectancy greater than 6 months
- Eligible for concurrent chemoradiotherapy as assessed by the principal investigator
- No obvious active bleeding
- Written informed consent provided before study registration
You will not qualify if you...
- Recurrent or distant metastatic disease
- Prior malignancies within 5 years, except curable non-melanoma skin cancer
- Active autoimmune diseases requiring systemic treatment or diseases needing long-term use of high-dose hormones or immunosuppressants
- Use of systemic corticosteroids (equivalent to prednisone 10 mg daily or higher) or other immunosuppressants within 14 days before enrollment or during the study
- Vaccination with live attenuated vaccine within 30 days prior to enrollment or planned during the study
- Previous organ transplantation or HIV infection
- Allergy to macromolecular proteins, monoclonal antibodies, or any study drug components
- Active acute or chronic viral hepatitis B or C with viral loads above specified thresholds
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
RenJi hospital
Shanghai, China, 200127
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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