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

NCT06916117 | Not Yet Recruiting Phase 2

• 1 other identifier: immunotherapy-LACC
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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-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.

Conditions

Locally Advanced Cervical Cancer

Keywords

immunotherapy; LACC; chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

• Progression disease free survival

  the time interval from the date of treatment to disease progression, local or distant recurrence

  2 year

Secondary Outcomes (1)

• Adverse events

  one year from the start of immunotherapy

Study Arms (1)

treatment arm

EXPERIMENTAL

Neoadjuvant chemotherapy (TP regimen) combined with PD-1 inhibitor was given, followed by concurrent chemoradiotherapy (cisplatin and PD-1 inhibitor) , and PD-1 inhibitor maintenance was given sequenced after RT.

Drug: Neoadjuvant Chemotherapy (NACT)

Interventions

Neoadjuvant Chemotherapy (NACT) DRUG

Neoadjuvant chemotherapy: The neoadjuvant regimen prior to radiotherapy consists of paclitaxel 135-175 mg/m², cisplatin 75 mg/m², and Sintilimab 200 mg, administered every 3 weeks for 2 cycles. Concurrent chemoradiotherapy: Radical dose to the pelvic concurrent with cisplatin. Consolidative immunotherapy: Following the completion of chemoradiotherapy, Sintilimab consolidation therapy will be administered based on treatment efficacy and the patient's physical condition, for a total of 6 cycles, starting 3-4 weeks after chemoradiotherapy.

treatment arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

Location

MeSH Terms

Interventions

Neoadjuvant Therapy

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Central Study Contacts

Dr. Chen

CONTACT

86-21-68383624; chenhaiyan1220@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 8, 2025
• Study Start: April 5, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2028
• Last Updated: April 8, 2025

Record last verified: 2025-03

Locations

CN (1)