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Trial Title:
Concurrent Chemoradiotherapy Followed by PD-1 Inhibitor in Advanced Cervical Cancer
NCT ID:
NCT06391190
Condition:
Locally Advanced Cervical Carcinoma
Concurrent Chemoradiotherapy
Immunotherapy
Conditions: Official terms:
Uterine Cervical Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
single arm
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Albumin-Bound Paclitaxel, cisplatin, Sintilimab
Description:
with Albumin-Bound Paclitaxel 50-75mg/m2, cisplatin 25-40 mg/m2 weekly for up to 5 cycles
during radical radiation; followed by Sintilimab 200mg Q3W for 8 cycles
Arm group label:
treatment arm
Other name:
radiation
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age between 18 and 75;
2. Untreated patients with pathologically proven locally advanced cervical cancer;
3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
4. 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
5. Life expectancy > 6 months
6. Eligible for concurrent chemoradiotherapy assessed by principle investigator;
7. No obvious active bleeding;
8. Written informed consent must be available before study registration.
Exclusion Criteria:
1. Recurrent or distant metastatic disease;
2. Prior malignancies (other than curable non-melanoma skin cancer) within 5 years;
3. Active autoimmune diseases requiring systemic treatment or other diseases requiring
long-term use of substantial amount of hormones or other immunosuppressants;
4. 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;
5. Vaccination of live attenuated vaccine 30 days before enrollment, or planned
vaccination of live attenuated vaccine during the study;
6. Previous organ transplantation or HIV patients;
7. Allergic to macromolecular proteins /monoclonal antibodies, or to any test drug
component;
8. 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
RenJi hospital
Address:
City:
Shanghai
Zip:
200127
Country:
China
Status:
Recruiting
Contact:
Last name:
Yongrui Bai, Dr
Phone:
+862168383459
Email:
baiyongrui@renji.com
Start date:
January 1, 2022
Completion date:
December 30, 2026
Lead sponsor:
Agency:
RenJi Hospital
Agency class:
Other
Source:
RenJi Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06391190
