NCT07092696 Induction Immunotherapy Combined With Chemotherapy Followed by Concurrent Chemoradiotherap and Immunotherapy for Cervical Cancer

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 34 participants in total. It began in 2024-12-01 with a primary completion date of 2025-12-01.

Brief Summary

To explore the efficacy and tolerability of a platinum-based regimen combined with the PD-1 antibody toripalimab administered prior to concurrent chemoradiotherapy in patients with locally advanced cervical cancer.

Eligibility Criteria

Inclusion Criteria: * Women aged 18-75 years. * Histologically confirmed, previously untreated locally advanced cervical cancer of squamous, adenocarcinoma, or adenosquamous type. * At least one measurable lesion that has not received prior local therapy (non-nodal lesion ≥ 10 mm longest diameter or pathological lymph node ≥ 15 mm short axis, per RECIST 1.1). * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1. * Estimated life expectancy ≥ 6 months. * Investigator-assessed eligibility for concurrent chemoradiotherapy. * No clinically significant active bleeding. * Laboratory values: WBC \> 4 × 10⁹/L; platelets \> 100 × 10⁹/L. * No history of other malignancies. * Women of child-bearing potential must have a negative serum pregnancy test and use effective contraception throughout the study. * Written informed consent obtained prior to any study-related procedures. Exclusion Criteria: * Tumor recurrence or distant metastasis at screening. * Active autoimmune disease requiring systemic therapy, or any chronic condition requiring long-term high-dose corticosteroids (≥10 mg/day prednisone or equivalent) or other immunosuppressive agents. * Systemic corticosteroids (\>10 mg/day prednisone or equivalent) or any other immunosuppressive drugs within 14 days before first study dose or anticipated during the study. * Live-attenuated vaccination within 30 days before first dose or planned during the study. * Prior organ transplantation or known HIV infection. * Active hepatitis B (HBV DNA \>2000 IU/mL or \>10⁴ copies/mL, or HBsAg positive) or active hepatitis C (HCV RNA \>10³ copies/mL); co-infection with both viruses is also excluded. * Prior therapy with any agent targeting PD-1, PD-L1, PD-L2, CD137, CTLA-4 (e.g., ipilimumab), or any other antibody or drug that modulates T-cell co-stimulation or checkpoint pathways. * Known hypersensitivity to monoclonal antibodies, fusion proteins, or any excipients in the investigational products. * History of another malignancy within the past 5 years, except adequately treated cervical carcinoma in situ, basal-cell carcinoma of the skin, or other localized malignancies considered cured. * Severe non-surgical comorbidity or acute infection. * Peripheral neuropathy \> Grade 1 (NCI-CTCAE). * Inadequate hematologic or organ function: * WBC \< 4.0 × 10⁹/L, ANC \< 1.5 × 10⁹/L, platelets \< 100 × 10⁹/L, Hb \< 90 g/L * TBIL \> 1.5 × ULN, ALT/AST \> 2.5 × ULN, BUN \> 1.5 × ULN, creatinine \> 1.5 × ULN * Symptomatic brain metastases. * Clinically significant cardiac arrhythmias, myocardial ischemia, severe conduction block, heart failure, or severe valvular disease. * Severe bone-marrow failure. * Uncontrolled psychiatric illness. * Pregnant or lactating women. * Investigator-judged unsuitability for the trial. * Concurrent participation in another interventional clinical study.

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