Actively Recruiting
Concurrent Chemoradiotherapy with Albumin-Bound Paclitaxel/Cisplatin Followed by PD-1 Inhibitor Sintilimab in Locally Advanced Cervical Cancer
Led by RenJi Hospital · Updated on 2024-04-30
20
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a treatment combining Albumin-Bound Paclitaxel and cisplatin chemotherapy with radiotherapy, followed by a PD-1 inhibitor called Sintilimab, in patients with locally advanced cervical cancer. This prospective trial aims to explore how well this combined approach works and its safety profile in this patient group. Participants will receive weekly doses of Albumin-Bound Paclitaxel (50-75 mg/m2) and cisplatin (25-40 mg/m2) for up to five weeks during radical radiation therapy, which includes external beam radiation followed by brachytherapy. After completing chemoradiotherapy, patients will receive Sintilimab 200 mg every three weeks for eight cycles as an immunotherapy treatment. During the study, participants will be closely monitored for disease progression and treatment safety for up to two years. Researchers will assess progression-free survival, objective response rate three months after treatment, and distant-metastasis-free survival. Safety evaluations will continue for one year, with regular clinical visits, laboratory tests, and assessments to track treatment effects and patient health.
CONDITIONS
Brief 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
- Pathologically confirmed locally advanced cervical cancer, untreated
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Adequate blood counts: hemoglobin > 8.0 g/dl, neutrophils > 2000 cells/µl, leukocytes > 4 × 10^9/L, platelets > 100 × 10^9/L
- Adequate kidney and liver function: serum urea nitrogen ≤ 1.5 × upper normal limit (UNL), serum creatinine ≤ 1.5 × UNL, serum ALT/AST ≤ 2.5 × UNL, serum total bilirubin ≤ 1.5 × UNL
- 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 long-term immunosuppressants
- Need for systemic corticosteroids (prednisone ≥10 mg daily) or other immunosuppressants within 14 days before enrollment or during the study
- Vaccination with live attenuated vaccine within 30 days before enrollment or planned during the study
- Previous organ transplantation or HIV infection
- Allergies to macromolecular proteins, monoclonal antibodies, or any study drug components
- Active acute or chronic hepatitis B or C with viral load above specified limits (HBV DNA > 2000 IU/ml or 10^4 copies/ml; HCV RNA > 10^3 copies/ml)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 29 weeks (5 weeks chemoradiotherapy plus 24 weeks of Sintilimab treatment)
Participants receive concurrent chemoradiotherapy with weekly Albumin-Bound Paclitaxel and cisplatin for up to 5 weeks during radiation therapy, followed by Sintilimab infusions every 3 weeks for 8 cycles.
Weekly visits for up to 5 weeks during chemoradiotherapy, then visits every 3 weeks for 8 cycles of Sintilimab
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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