Status:
NOT_YET_RECRUITING
Neoadjuvant Chemo-immunotherapy Followed by Concurrent Chemoradiotherapy and Immunotherapy in LACC
Lead Sponsor:
RenJi Hospital
Conditions:
Locally Advanced Cervical Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
Brief Summary
Concurrent chemoradiotherapy -immunotherapy followed by ICI maintenance was proved to improve the PFS by the Keynote-A18 in the LACC patients, and still more than 30% progressed. Neoadjuvant chemo-imm...
Detailed Description
This prospective single arm study aims to investigate the efficacy and safety of neoadjuvant immuno-chemotherapy followed by concurrent chemoradiotherapy and consolidative immunotherapy in LACC patien...
Eligibility Criteria
Inclusion
- (1)Age between 18 and 75; (2)Untreated patients with pathologically proven squamous carcinoma; (3)T3-4N1-2M0 cervical cancer; (4)Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1; (5)Adequate hematological, renal and hepatic functions: (6)Hemoglobin \> 8.0 g/dl ; Neutrophils \> 2000 cells/μl; Leukocytes \> 4 × 109/L; Platelets \> 100 × 109/L; Serum urea nitrogen (BUN) ≤ 1.5 × upper normal limit (UNL); Serum creatinine (Cr) ≤ 1.5 × upper normal limit (UNL); Serum ALT/AST ≤ 2.5× UNL; Serum Total bilirubin ≤ 1.5× UNL; (7)Life expectancy \> 6 months; (8)Eligible for concurrent chemoradiotherapy assessed by principle investigator; (9)No obvious active bleeding; (10)Written informed consent must be available before study registration.
Exclusion
- (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\> 2000 IU/ml or 104 copies/ml; hepatitis C virus (HCV) RNA\> 10\^3 copies/ml.
Key Trial Info
Start Date :
April 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06916117
Start Date
April 5 2025
End Date
December 30 2028
Last Update
April 8 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Renji Hospital
Shanghai, Shanghai Municipality, China, 200127