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NCT06916117Not yet recruitingPhase 2

Neoadjuvant Chemo-immunotherapy Followed by Concurrent Chemoradiotherapy and Immunotherapy in LACC

A Prospective Single Arm Trial of Neoadjuvant Chemo-immunotherapy Followed by Concurrent Chemoradiotherapy and Immunotherapy in Locally Advanced Cervical Cancer

Source: ClinicalTrials.gov · Last updated 8 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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-immunotherapy in LACC resulted in higher pCR rate. This prospective single arm study is to investigate the efficacy and safety of neoadjuvant immuno-chemotherapy followed by concurrent chemoradiotherapy and consolidative immunotherapy in LACC patients.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
30 (estimated)
First submitted
31 Mar 2025
Start date
5 Apr 2025
Primary completion date
30 Dec 2026
Lead sponsor
RenJi Hospital
NCT number
NCT06916117

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 30
  • From 5 Apr 2025 to the primary completion date, 30 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • (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.

Who the study is looking for

  • (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.

Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
RenJi Hospital
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.