Concurrent Chemoradiotherapy Followed by PD-1 Inhibitor in Advanced Cervical Cancer
Recruiting now · Phase 1/Phase 2
Conditions studied: Locally Advanced Cervical Carcinoma, Concurrent Chemoradiotherapy, Immunotherapy
In brief
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
Key facts
- Study ID
- NCT06391190
- Run by
- RenJi Hospital
- People needed
- 20
- Starts
- 2022-01-01
- Expected to finish
- 2026-12-30
- Last updated by the study team
- 2024-04-30
Who can join
Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Age between 18 and 75;
- Untreated patients with pathologically proven locally advanced cervical cancer;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
- Adequate hematological, renal and hepatic functions:
- 1 Hemoglobin > 8.0 g/dl 4.2 Neutrophils > 2000 cells/μl; Leukocytes > 4 × 109/L 4.3 Platelets > 100 × 109/Lg. 4.4 Serum urea nitrogen (BUN) ≤ 1.5 × upper normal limit (UNL) 4.5 Serum creatinine (Cr) ≤ 1.5 × upper normal limit (UNL) 4.6 Serum ALT/AST ≤ 2.5× UNL 4.7 Serum Total bilirubin ≤ 1.5× UNL
- Life expectancy > 6 months
- Eligible for concurrent chemoradiotherapy assessed by principle investigator;
- No obvious active bleeding;
- Written informed consent must be available before study registration.
You may not qualify if…
- Recurrent or distant metastatic disease;
- Prior malignancies (other than curable non-melanoma skin cancer) within 5 years;
- Active autoimmune diseases requiring systemic treatment or other diseases requiring long-term use of substantial amount of hormones or other immunosuppressants;
- Patients who need to receive systemic corticosteroids (dose equivalent to or higher than prednisone 10mg qd) or other immunosuppressants within 14 days before enrollment or during the study;
- Vaccination of live attenuated vaccine 30 days before enrollment, or planned vaccination of live attenuated vaccine during the study;
- Previous organ transplantation or HIV patients;
- Allergic to macromolecular proteins /monoclonal antibodies, or to any test drug component;
- Active acute or chronic viral hepatitis B or C. Hepatitis B virus (HBV) DNA> 2000IU/ml or 104 copies/ml; hepatitis C virus (HCV) RNA> 103 copies/ml.
Where it is running
- RenJi hospital — Shanghai, China (enrolling)
Full record on ClinicalTrials.gov
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