Concurrent Chemoradiotherapy Followed by PD-1 Inhibitor in Advanced Cervical Cancer
- Conditions
- ImmunotherapyLocally Advanced Cervical CarcinomaConcurrent Chemoradiotherapy
- Interventions
- Drug: Albumin-Bound Paclitaxel, cisplatin, Sintilimab
- Registration Number
- NCT06391190
- Lead Sponsor
- RenJi Hospital
- Brief Summary
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
- Detailed Description
Patients with pathologically confirmed locally advanced cervical cancer will be treated with concurrent chemoradiotherapy (weekly Albumin-Bound Paclitaxel and cisplatin), followed by Sintilimab 200mg q3w for 8 cycles.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 20
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Age between 18 and 75;
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Untreated patients with pathologically proven locally advanced cervical cancer;
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Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
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Adequate hematological, renal and hepatic functions:
4.1 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
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Life expectancy > 6 months
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Eligible for concurrent chemoradiotherapy assessed by principle investigator;
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No obvious active bleeding;
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Written informed consent must be available before study registration.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description treatment arm Albumin-Bound Paclitaxel, cisplatin, Sintilimab with Albumin-Bound Paclitaxel 50-75mg/m2, cisplatin 25-40 mg/m2 weekly for up to 5 cycles during radical radiation (EBRT followed by brachytherapy); followed by Sintilimab 200mg Q3W for 8 cycles.
- Primary Outcome Measures
Name Time Method progression disease free survival -2 years the time interval from the date of treatment to disease progression, local or distant recurrence.
safety of Albumin-Bound Paclitaxel/cisplatin based concurrent chemoradiotherapy followed by Sintilimab -1 years the occurrence and grade of side effect from treatment according to the CTCAE 4.0 and NCCN clinical practice guidelines in the evaluation treatment-related toxicity (through the symptoms, physical examination, and also through blood/image/encoscopy examination, such as blood routine, liver and renal function, TSH/T3/T4/ACTH concentration, myocardial enzymes, and EKG, echocardiography, CT, et al).
- Secondary Outcome Measures
Name Time Method Objective Response Rate (ORR) 3 months the percentage of the participants in the population who have a Complete Response or Partial Response accordingly to RECIST 1.1
distant-metastasis free survival -2 years the time interval from the date of treatment to distant recurrence.
Trial Locations
- Locations (1)
RenJi hospital
🇨🇳Shanghai, China