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

Shanghai Jiao Tong University

Status and phase: Not yet enrolling; Phase 2

Conditions: Locally Advanced Cervical Cancer

Treatments: Drug: Neoadjuvant Chemotherapy (NACT)

Study type: Interventional

Funder types: Other

Identifiers

NCT06916117

immunotherapy-LACC

Details and patient eligibility

About

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.

Full 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 patients. Patients will be given two cycles of TP regimen + Sintilimab, followed by concurrent chemoraiotherapy, and consolidative 6 cycles of Sintilimab.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• (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 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> 2000 IU/ml or 104 copies/ml; hepatitis C virus (HCV) RNA> 10^3 copies/ml.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

treatment arm

Experimental group

Description:

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.

Treatment:

Drug: Neoadjuvant Chemotherapy (NACT)