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

Recruiting now · Phase 2

Conditions studied: Cervical Cancer

In brief

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.

Key facts

Study ID

NCT07092696

Run by

Tianjin Medical University Cancer Institute and Hospital

People needed

34

Starts

2024-12-01

Expected to finish

2028-12-01

Last updated by the study team

2025-07-30

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Tianjin Medical University Cancer Institute&Hospital — Tianjin, China (enrolling)

Full record on ClinicalTrials.gov

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